Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, X-Ray, Stationary

FDA product code KPR · 331 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1680
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-26 – 2026-09-08

KPR 2016-11-22

Multix Fusion Max

Applicant Siemens Medical Solutions USA, Inc.

K number K162971

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KPR 2016-10-06

CuattroDR

Applicant Cuattro, LLC

K number K161937

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KPR 2016-09-22

ArtPix Mobile EZ2GO

Applicant Cmt Medical Technologies, Ltd.

K number K162224

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KPR 2016-07-15

FDR Visionary Suite

Applicant Shimadzu Corporation

K number K152294

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KPR 2016-07-06

GC85A

Applicant Samsung Electronics Co., Ltd.

K number K160997

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KPR 2016-06-20

RADspeed Pro

Applicant Shimadzu Corporation

K number K152244

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KPR 2016-03-30

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

Applicant Visaris D.O.O. Belgrade

K number K160620

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KPR 2016-03-14

Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,

Applicant Summit Industries, LLC

K number K153119

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KPR 2013-11-12

GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS

Applicant Radiology Solutions, LLC

K number K132294

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KPR 2013-06-20

DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A

Applicant Samsung Electronics Co., Ltd.

K number K123106

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KPR 2013-06-07

XGEO GU60

Applicant Samsung Electronics Co., Ltd.

K number K123105

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KPR 2013-02-15

CPI RAD VISION

Applicant Communications & Power Industries Canada, Inc.

K number K122726

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KPR 2013-01-18

XGEO GC80

Applicant Samsung Electronics Co., Ltd.

K number K123098

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KPR 2012-11-20

FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION

Applicant Fujifilm Medical System U.S.A., Inc.

K number K122454

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KPR 2012-10-05

DFP4343C7

Applicant Mdi Consultants, Inc.

K number K122589

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KPR 2012-09-13

DX-D FULL LEG FULL SPINE

Applicant Afga Healthcare N.V.

K number K122119

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KPR 2012-08-22

SYSTEM, X-RAY, STATIONARY

Applicant Beijing Sinopharm Hundric Mediline Info. Tech. Co.

K number K121854

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KPR 2012-08-10

MULTIX FUSION

Applicant Siemens Medical Solution

K number K121513

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KPR 2012-06-08

AERODR STITCHING SYSTEM

Applicant Konica Minolta Medical & Graphic, Inc.

K number K120752

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KPR 2012-06-01

SR SUITE 1.0

Applicant Halifax Biomedical, Inc.

K number K121345

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KPR 2012-05-23

AERODR X70

Applicant Konica Minolta Medical & Graphic, Inc.

K number K121109

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KPR 2012-04-17

RADIOGRAPHIC X-RAY SYSTEM

Applicant Orich Medical Equipment (Tianjin Co., Ltd.

K number K120034

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KPR 2012-01-25

PANORAD, PANORAD SL

Applicant Imix Adr Finland OY

K number K113855

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KPR 2012-01-17

AERODR SYSTEM WITH P-21

Applicant Konica Minolta Medical & Graphic, Inc.

K number K113248

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KPR 2011-11-30

FLAATZ 760

Applicant Drtech Corp.

K number K111655

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KPR 2011-10-27

DX-D 600

Applicant Agfa Healthcare N.V.

K number K112670

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KPR 2011-08-23

DDRELEMENT

Applicant Swissray Medical AG

K number K110828

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KPR 2011-08-12

BRIVO XR385

Applicant Ge Medical Systems, LLC

K number K103448

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KPR 2011-05-16

CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM

Applicant Jpi Healthcare Co, Ltd.

K number K101779

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KPR 2011-04-26

PRESTODR 4143

Applicant Cmt Medical Technologies, Ltd.

K number K110849

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KPR 2011-01-24

VIZION DR

Applicant Viztek, Inc.

K number K102123

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KPR 2011-01-03

KRYSTALRAD (ATAL8)

Applicant Medicatech USA

K number K102285

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KPR 2011-01-03

KRYSTALRAD 560 (FLAATZ 560)

Applicant Medicatech USA

K number K102284

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KPR 2010-12-27

DIGITAL DIAGNOSTIC X-RAY SYSTEM

Applicant DRGEM Corporation

K number K102408

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KPR 2010-11-24

AERODR SYSTEM

Applicant Konica Minolta Medical & Graphic, Inc.

K number K102349

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KPR 2010-10-29

DX-D 300

Applicant Agfa Healthcare N.V.

K number K103050

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KPR 2010-10-29

FDR IMAGE STITCHING OPTION

Applicant Fujifilm Medical System U.S.A., Inc.

K number K101686

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KPR 2010-10-29

BLADEVIEW

Applicant Accogent, LLC

K number K101042

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KPR 2010-10-22

Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM

Applicant Control-X Medical, Inc.

K number K102680

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KPR 2010-10-05

DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600

Applicant Medien International Co, Ltd.

K number K093816

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KPR 2010-09-15

IMIX PANORAD AND SOMARAD

Applicant Imix Adr Finland OY

K number K101435

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KPR 2010-07-21

DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000

Applicant VATECH Co., Ltd.

K number K092830

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KPR 2009-11-12

VIZTEK WL

Applicant Viztek, Inc.

K number K091752

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KPR 2009-08-25

IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR

Applicant Imasight, Inc.

K number K092307

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KPR 2009-07-20

DRX-EVOLUTION, MODEL VX3733-SYS

Applicant Carestream Health, Inc.

K number K091889

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KPR 2009-07-01

FLAATZ 500

Applicant Drtech Corp.

K number K091747

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KPR 2009-06-29

DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D

Applicant Choong Wae Medical Corp.

K number K083640

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KPR 2009-03-11

SEDECAL, MILLENNIUM PLUS

Applicant Sedecal., Sa.

K number K090279

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KPR 2009-02-27

SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS

Applicant Sedecal., Sa.

K number K090238

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KPR 2009-02-13

DRAD30003/RADREX-I

Applicant Toshiba America Medical Systems, In.C

K number K083503

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KPR 2009-01-08

KUBTEC XPERT 20

Applicant Kub Technologies, Inc.

K number K083510

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KPR 2008-12-04

SUINSA DIAGNOSTIC X-RAY SYSTEM

Applicant Suinsa

K number K083109

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KPR 2008-11-26

QV-9000 UNIVERSAL SYSTEM

Applicant Quantum Medical Imaging, LLC

K number K083181

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KPR 2008-11-21

VIZTEK DR, MODELS: DR1000, DR3000, DR4000

Applicant Viztek, Inc.

K number K082604

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KPR 2008-11-06

DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS

Applicant Dxrad Solutions , Ltd.

K number K082261

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KPR 2008-10-28

DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000

Applicant Medicatech USA

K number K082798

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KPR 2008-08-22

RADVISION ET DIAGNOSTIC X-RAY SYSTEM

Applicant Almana Medical Imaging

K number K082064

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KPR 2008-08-22

YSIO

Applicant Siemens Medical Solutions USA, Inc.

K number K081722

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KPR 2008-07-30

CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM

Applicant Carestream Health, Inc.

K number K081836

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KPR 2008-06-20

DR VISION NEO, DR VISION DOU

Applicant Almana Medical Imaging

K number K080614

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KPR 2008-05-15

MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA

Applicant Medicatech USA

K number K080582

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KPR 2008-05-09

CHRYSALIS

Applicant Meta Imaging Solutions, LLC

K number K080655

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KPR 2008-04-16

DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16

Applicant Vieworks Co., Ltd.

K number K080553

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KPR 2008-02-06

FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371

Applicant Fujifilm Medical Systems U.S.A, Inc.

K number K073650

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KPR 2008-01-17

IMIX INSIGHT X-RAY SYSTEMS

Applicant Imix Adr Finland OY

K number K073114

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KPR 2008-01-10

INTUITION, MODEL 0170

Applicant Arcoma AB

K number K073632

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KPR 2007-11-21

IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K

Applicant Imix Adr Finland OY

K number K072867

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KPR 2007-11-15

RAD VISION, MODELS E AND EU

Applicant Almana Medical Imaging

K number K072659

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KPR 2007-09-18

EOS

Applicant Biospace Med

K number K071546

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KPR 2007-08-07

QUANTUM DIREX SYSTEM

Applicant Quantum Medical Imaging, LLC

K number K072010

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KPR 2007-08-03

PXS-810, PODIATRY X-RAY SYSTEM

Applicant Source-Ray, Inc.

K number K071392

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KPR 2007-06-22

X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM

Applicant Imaging Dynamics Company , Ltd.

K number K071401

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KPR 2007-06-21

SYNERAD OMNI, MODELS AN6255 AND AN6265

Applicant Analogic Corp.

K number K071430

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KPR 2007-06-13

X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR

Applicant Imaging Dynamics Company , Ltd.

K number K071408

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KPR 2007-06-11

X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM

Applicant Imaging Dynamics Company , Ltd.

K number K071403

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KPR 2007-06-08

X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM

Applicant Imaging Dynamics Company , Ltd.

K number K071409

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KPR 2007-06-08

X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM

Applicant Imaging Dynamics Company , Ltd.

K number K071402

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KPR 2007-05-02

DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST

Applicant Swissray International, Inc.

K number K070678

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KPR 2006-11-22

XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND

Applicant Imaging Dynamics Company , Ltd.

K number K063247

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KPR 2006-11-22

XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND

Applicant Imaging Dynamics Company , Ltd.

K number K063246

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KPR 2006-10-06

ORTHOXP

Applicant Imaging Dynamics Company , Ltd.

K number K062634

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KPR 2006-09-15

XPLORER 1100

Applicant Imaging Dynamics Company , Ltd.

K number K062417

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KPR 2006-09-14

SEDECAL X PLUS LP PLUS

Applicant Sedecal., Sa.

K number K062335

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KPR 2006-09-13

XPLORER 1590

Applicant Imaging Dynamics Company , Ltd.

K number K062405

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KPR 2006-08-17

XAMINER

Applicant Imaging Dynamics Company , Ltd.

K number K061595

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KPR 2006-03-31

KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386

Applicant Eastman Kodak Company

K number K060550

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KPR 2005-12-15

DDRFORMULA AND DDRFORMULA PLUS

Applicant Swissray Medical AG

K number K052943

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KPR 2005-11-03

MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM

Applicant Avant Medical Systems

K number K052541

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KPR 2005-08-09

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS

Applicant GE Healthcare

K number K051967

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KPR 2005-06-01

KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345

Applicant Eastman Kodak Company

K number K051258

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KPR 2005-04-08

MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING

Applicant General Electric Co.

K number K050704

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KPR 2005-03-18

UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS

Applicant Medlink Imaging

K number K033577

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KPR 2005-02-09

MULTIDIAGNOST ELEVA

Applicant Philips Medical Systems North America, Inc.

K number K050151

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KPR 2004-11-19

SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250

Applicant Analogic Corp.

K number K043025

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KPR 2004-11-18

URS LP DIGITAL, MILLENNIUM, RADPRO

Applicant Sedecal., Sa.

K number K042876

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KPR 2004-05-25

SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150

Applicant Analogic Corp.

K number K040995

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KPR 2003-11-19

AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS

Applicant Analogic Corp.

K number K033345

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KPR 2003-06-17

PHILIPS EASYDIAGNOST ELEVA

Applicant Philips Medical Systems North America Co.

K number K031535

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KPR 2002-11-13

UNIVERSAL SYSTEM, MODEL QV-800

Applicant Quantum Medical Imaging, LLC

K number K023008

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KPR 2002-10-22

HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC

Applicant Health Care Mfg., Inc.

K number K022737

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