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 2002-10-22

HCMI X-RAY

Applicant Health Care Mfg., Inc.

K number K022667

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KPR 2002-02-01

AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)

Applicant Siemens Medical Systems, Inc.

K number K013826

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KPR 2001-11-02

DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION

Applicant GE Medical Systems

K number K013481

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KPR 2001-11-02

OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM

Applicant Sedecal USA, Inc.

K number K012546

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KPR 2001-09-19

OLDELFT THORASCAN MODEL NUMBER 180T

Applicant Nucletron Corp.

K number K012165

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KPR 2001-08-10

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM

Applicant Ge Medical Systems, Inc.

K number K012389

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KPR 2001-06-20

Q-RAD RADIOGRAPHIC SYSTEM

Applicant Quantum Medical Imaging, LLC

K number K011486

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KPR 2001-05-30

MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)

Applicant Modular X-Ray Devices

K number K011111

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KPR 2000-06-02

DR5000 DEDICATED CHEST X-RAY SYSTEM

Applicant Analogic Corp.

K number K001341

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KPR 2000-06-02

DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM

Applicant Analogic Corp.

K number K001336

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KPR 2000-06-01

MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS

Applicant Siemens Medical Solutions USA, Inc.

K number K001201

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KPR 1999-12-21

PENSIL TRAUMA, MODEL WWS6100

Applicant Wuestec Medical, Inc.

K number K993962

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KPR 1999-11-12

LEGEND CRF FLUORO AND RAD SYSTEM

Applicant Ge Medical Systems, Inc.

K number K993665

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KPR 1999-10-01

SILHOUETTE FC

Applicant Ge Medical Systems, Inc.

K number K993090

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KPR 1999-08-30

REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM

Applicant GE Medical Systems

K number K992066

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KPR 1999-04-16

SHIMADZU CEILING TUBE SUPPORT CH-30GH

Applicant Shimadzu Corp.

K number K990715

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KPR 1999-03-03

TOPOGRAPHIC IMAGING MARKER

Applicant I.Z.I. Medical Products Corp.

K number K990298

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KPR 1999-03-03

TOPOGRAPHIC IMAGING MARKER

Applicant I.Z.I. Medical Products Corp.

K number K990242

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KPR 1998-12-11

FV-RF

Applicant Philips Medical Systems (Cleveland), Inc.

K number K984111

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KPR 1998-11-04

SILHOUETTE VR

Applicant GE Medical Systems

K number K982955

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KPR 1998-10-29

X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID

Applicant I.E.D., Inc.

K number K982824

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KPR 1998-10-20

DX-480, ADD ON DIGITAL IMAGER

Applicant Wuestec Medical, Inc.

K number K981880

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KPR 1998-10-06

DIGITAL RADIOGRAPHIC IMAGING SYSTEM

Applicant GE Medical Systems

K number K982196

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KPR 1998-06-18

PHILIPS THORAVISION

Applicant Philips Medical Systems North America, Inc.

K number K981657

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KPR 1998-06-12

VARIAN XIMATRON SCAN VISION CT

Applicant Varian Medical Systems, Inc.

K number K981056

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KPR 1998-04-17

OLDELFT DIGIDELCA

Applicant Oldelft Corp. of America

K number K980296

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KPR 1998-03-17

IMIX DIGITAL THORAX SYSTEM

Applicant Advanced Instrument Development, Inc.

K number K974863

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KPR 1998-03-09

ADC COMPACT (AGFA DIAGNOSTIC CENTER)

Applicant Bayer Corp., Agfa Div.

K number K974597

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KPR 1998-01-29

VACUDAP, MODEL 2000, 2001

Applicant Victoreen, Inc.

K number K974112

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KPR 1997-12-18

DIGITAL ADD ON MULTI SYSTEM

Applicant Swissray International, Inc.

K number K973710

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KPR 1997-11-21

DIGITAL ADD-ON BUCKY

Applicant Swissray Teleray AG

K number K970136

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KPR 1997-10-08

AMBER DU

Applicant Oldelft Corp. of America

K number K973219

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KPR 1997-08-14

PIVOTING COMPENSATING FILTERS FOR THE HEAD

Applicant Octostop, Inc.

K number K972766

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KPR 1997-07-08

X-RAY ASSIST BAR

Applicant Ralph Lindel, D.C.

K number K972000

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KPR 1996-11-27

THE PHARAOH COMPENSATING FILTER

Applicant Octostop, Inc.

K number K963941

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KPR 1996-09-20

KODAK DIGITAL SCIENCE REMOTE CASSETTE

Applicant Eastman Kodak Company

K number K962896

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KPR 1995-10-24

UNIVERSIX 120

Applicant Philips Medical Systems (Cleveland), Inc.

K number K954196

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KPR 1995-09-12

SOLARIX FV

Applicant GE Medical Systems

K number K953832

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KPR 1995-07-20

RIDGES PLUS

Applicant Octostop, Inc.

K number K952871

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KPR 1995-07-13

VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM

Applicant Bennett X-Ray Corp.

K number K952672

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KPR 1995-05-11

FAST FIND GRID

Applicant Webb Research, Inc.

K number K950980

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KPR 1995-04-19

UPSCAN

Applicant Merlin Engineering Works, Inc.

K number K933512

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KPR 1995-01-18

SHOULDER RETRACTOR

Applicant Northwest Medical Physics Center

K number K944613

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KPR 1994-12-14

SII 525 MS

Applicant Scott Imaging Intl., Inc.

K number K945709

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KPR 1994-12-14

SII 360 MS

Applicant Scott Imaging Intl., Inc.

K number K945708

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KPR 1994-12-14

PHILIPS BUCKY DIAGNOST FAMILY

Applicant Philips Medical Systems North America, Inc.

K number K945278

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KPR 1994-12-12

BES - BREATH EXPOSURE SYNCHRONIZER

Applicant The Henry G. Dietz Co., Inc.

K number K942581

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KPR 1994-10-20

CARPAL BOX

Applicant Innovative Medical Technologies, Inc.

K number K936087

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KPR 1994-09-15

PHILIPS THORAVISION

Applicant Philips Medical Systems, Inc.

K number K931071

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KPR 1994-09-06

OCTOSTOP COMPENSATING FILTERS

Applicant Octostop, Inc.

K number K940306

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KPR 1994-07-29

BUCKY STAND BR-10M

Applicant Shimadzu Corp.

K number K942792

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KPR 1994-06-06

WEIGHT BAG

Applicant Biocor, Inc.

K number K941592

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KPR 1994-05-26

DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR

Applicant Victoreen, Inc.

K number K941931

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KPR 1994-02-09

WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY

Applicant Bennett X-Ray Corp.

K number K935649

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KPR 1993-12-13

WHITMORE ANKLE X-RAY EXTENSION (AXE)

Applicant Whitmore Ent., Inc.

K number K933778

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KPR 1993-11-24

SHIMADZU CEILING TUBE SUPPORT CH-30GX

Applicant Shimadzu Corp.

K number K934005

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KPR 1993-11-19

FAST FIND GRIND

Applicant Webb Research Ii, Inc.

K number K934755

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KPR 1993-09-20

CERVICAL TRACTION STRAP

Applicant Cook (Canada), Inc.

K number K933023

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KPR 1993-05-17

525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR

Applicant Tingle X-Ray Products, Inc.

K number K926554

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KPR 1993-05-17

TOP-X 650HF RADIOGRAPHIC X-RAY

Applicant Control-X, Inc.

K number K920347

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KPR 1993-04-27

FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK

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

K number K921112

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KPR 1993-01-21

WRIST TRACTION

Applicant Octostop, Inc.

K number K926069

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KPR 1992-12-28

HFG 350, 650, 1050

Applicant Varian Canada, Inc.

K number K923455

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KPR 1992-11-05

PXI URCD

Applicant Brotherston/Pxi

K number K913435

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KPR 1992-10-14

GENTLE SLOPE

Applicant Octostop, Inc.

K number K913711

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KPR 1992-10-14

LITTLE PRISM

Applicant Octostop, Inc.

K number K913659

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KPR 1992-08-11

GEN-X 800-400 -- MODIFICATION

Applicant Swiss Ray Medical Systems

K number K922813

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KPR 1992-08-11

GEN-X 800/6/50

Applicant Swiss Ray Medical Systems

K number K921539

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KPR 1992-04-06

VORTECH'S FILM DIGITIZER, FD-1

Applicant Vortech Data, Inc.

K number K915362

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KPR 1992-03-06

KONICA DIRECT DIGITIZER KD-1000

Applicant Konica Corp.

K number K920558

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KPR 1991-10-30

HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST

Applicant Hologic, Inc.

K number K913757

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KPR 1991-09-19

FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109

Applicant Continental X-Ray Corp.

K number K912517

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KPR 1991-09-19

FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-9110

Applicant Continental X-Ray Corp.

K number K912515

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KPR 1991-09-16

THE BULLION

Applicant Octostop, Inc.

K number K910757

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KPR 1991-06-21

NDI MODEL IRS-TD

Applicant National Diagnostic Imaging, Inc.

K number K904676

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KPR 1990-12-13

HUGH YOUNG II UROLOGICAL X-RAY SYSTEM

Applicant Mallinckrodt Group, Inc.

K number K904147

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KPR 1990-12-13

NEURO VISION RADIOGRAPHIC X-RAY SYSTEM

Applicant Mallinckrodt Group, Inc.

K number K904146

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KPR 1990-12-13

HYDRA VISION UROLOGICAL X-RAY SYSTEM

Applicant Mallinckrodt Group, Inc.

K number K904145

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KPR 1990-10-29

G.E. 48-4 CEILING TUBEHANGER

Applicant Electromek Diagnostic Systems, Inc.

K number K902791

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KPR 1990-09-27

RADIOPAQUE RULER

Applicant Professional Medical Services

K number K902606

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KPR 1990-06-14

CARDIOTHORACIC RULER

Applicant Devcom, Inc.

K number K902378

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KPR 1990-04-10

TRANS X 100 CHEST FILM CHANGER

Applicant Acoma Medical Imaging, Inc.

K number K900562

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KPR 1989-03-15

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B

Applicant Shimadzu Precision Instruments, Inc.

K number K884477

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KPR 1988-11-04

MEDRAD OMNIPLANE 300 SYSTEM

Applicant Medrad, Inc.

K number K883834

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KPR 1988-09-08

CATAPULT BUCKY (KATAPULT BLENDA)

Applicant Bay X-Ray, Inc.

K number K883160

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KPR 1988-07-14

MTX GENERATOR

Applicant Philips Medical Systems (Cleveland), Inc.

K number K880352

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KPR 1988-06-06

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY

Applicant Orion Corporation Soredex

K number K880982

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KPR 1988-02-22

A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH

Applicant M.C. Johnson Co., Inc.

K number K872525

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KPR 1987-08-12

BC 1800 FINGER POSITIONER

Applicant Instrumentation Industries, Inc.

K number K872317

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KPR 1987-08-12

BC 1400 HAND POSITIONER

Applicant Instrumentation Industries, Inc.

K number K872316

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KPR 1987-07-01

JOVI MYELOGRAPHY HARNESS

Applicant Jovi, Inc.

K number K872468

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KPR 1987-06-18

SCX INFORMATION MANAGEMENT SYSTEM

Applicant General Electric Co.

K number K870400

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KPR 1987-03-25

BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75

Applicant Belmont Equipment Corp.

K number K870300

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KPR 1987-01-16

REFURBISH DIAGNOSTIC X-RAY EQUIPMENT

Applicant Chemarts and Assoc., Inc.

K number K863309

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KPR 1986-09-02

AMBER-CHEST

Applicant Old Delft Corp. of America

K number K862616

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KPR 1986-07-18

MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM

Applicant Medicor USA , Ltd.

K number K861994

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KPR 1986-05-07

MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR

Applicant Medicor USA , Ltd.

K number K860025

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KPR 1986-03-06

KEITHLEY MODEL 75100 & 75200

Applicant Keithley Instruments, Inc.

K number K854110

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KPR 1986-02-12

UPRIGHT BUCKY STAND/MOUNT

Applicant X-Ray Systems

K number K855161

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KPR 1985-11-15

BOOMERANG ABSORPTION COMENSATION FILTER

Applicant Entreprises Octostop, Inc.

K number K853330

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