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System, X-Ray, Mobile

FDA product code IZL · 226 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1720
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-05 – 2026-08-03

IZL 2011-08-05

SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY

Applicant Sedecal., Sa.

K number K101517

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IZL 2011-07-19

MOBILEDIAGNOST WDR

Applicant Sedecal., Sa.

K number K111725

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IZL 2011-06-16

BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

Applicant Ge Medical Systems, LLC

K number K103476

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IZL 2011-01-26

SEDECAL

Applicant Sedecal., Sa.

K number K103522

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IZL 2011-01-03

DX-D 100

Applicant Agfa Healthcare N.V.

K number K103597

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IZL 2010-07-16

SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM

Applicant Transamerican Medical Imaging

K number K092713

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IZL 2010-04-23

MINXRAY MODEL CMDR-2S

Applicant Minxray, Inc.

K number K100449

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IZL 2010-04-22

PRESTODR PORTABLE

Applicant Cmt Medical Technologies, Ltd.

K number K100400

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IZL 2009-07-14

PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260

Applicant Source-Ray, Inc.

K number K090655

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IZL 2009-06-30

SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION

Applicant Shimadzu Corp.

K number K090268

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IZL 2009-03-17

EASY MOVING PLUS, SM-XXHF-YY

Applicant Sedecal., Sa.

K number K090322

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IZL 2008-11-21

NEORAY DR 2520 DIGITAL IMAGING SYSTEM

Applicant Portavision Medical, LLC

K number K083048

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IZL 2008-11-07

MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL

Applicant Minxray, Inc.

K number K082627

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IZL 2008-05-14

SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION

Applicant Shimadzu Corp.

K number K080701

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IZL 2008-04-18

FCR GO PORTABLE DIGITAL X-RAY SYSTEM

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

K number K080945

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IZL 2007-09-25

OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K072392

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IZL 2007-07-11

SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110

Applicant Soyee Product, Inc.

K number K070634

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IZL 2007-05-10

OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K071015

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IZL 2006-12-26

AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS

Applicant Virtual Imaging

K number K063262

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IZL 2006-10-31

OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115

Applicant Source-Ray, Inc.

K number K062472

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IZL 2006-09-15

PULSERA

Applicant Philips Medical Systems North America Co.

K number K061685

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IZL 2006-04-05

MINXRAY, MODELS HFP24 AND HFP40

Applicant Mikasa X-Ray Co., Ltd.

K number K060566

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IZL 2005-11-08

GE DEFINIUM AMX 700, MODEL AMX 700

Applicant General Electric Medical Systems

K number K052897

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IZL 2005-10-27

MINXRAY, MODEL HF100H+

Applicant Minxray, Inc.

K number K052721

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IZL 2005-10-07

AJEX 9015/135H PORTABLE X-RAY

Applicant Jpi America, Inc.

K number K052341

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IZL 2005-08-11

MODEL SR-115 PORTABLE X-RAY SYSTEM

Applicant Source-Ray, Inc.

K number K052001

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IZL 2004-12-13

MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM

Applicant Source-Ray, Inc.

K number K043062

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IZL 2004-11-18

SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR

Applicant Sedecal., Sa.

K number K043002

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IZL 2004-11-02

AMX5 AND AMX5D MOBILE X-RAY SYSTEMS

Applicant Ge Healthcare Technologies

K number K042866

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IZL 2004-10-04

PRACTIX CONVENIO

Applicant Philips Medical Systems North America Co.

K number K042368

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IZL 2004-09-29

DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D

Applicant Sedecal USA, Inc.

K number K042361

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IZL 2004-07-28

GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR

Applicant General Electric Co.

K number K041922

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IZL 2004-07-13

SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES

Applicant Shimadzu Corp.

K number K041763

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IZL 2004-02-02

MINXRAY, MODEL HF120/60H POWERPLUS

Applicant Minxray, Inc.

K number K040046

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IZL 2004-02-02

PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF

Applicant United Radiology Systems, Inc.

K number K032628

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IZL 2003-11-14

MOBILETTE XP AND MOBILETT XPHYBRID

Applicant Siemens Medical Systems, Inc.

K number K033238

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IZL 2003-09-10

SIREMOBIL ISO-C 3D

Applicant Siemens AG

K number K032280

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IZL 2003-05-20

SR-130

Applicant Source-Ray, Inc.

K number K030494

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IZL 2002-08-13

3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D

Applicant Siemens Medical Solutions USA, Inc.

K number K022337

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IZL 2002-06-17

AMX-4 PLUS MOBILE X-RAY SYSTEM

Applicant GE Medical Systems

K number K021016

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IZL 2002-02-22

PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0

Applicant Sedecal., Sa.

K number K020436

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IZL 2001-08-31

EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)

Applicant Sedecal USA, Inc.

K number K012663

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IZL 2001-08-16

PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM

Applicant Trex Enterprises Corp.

K number K012379

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IZL 2001-02-12

MXR-2000 MOBILE X-RAY UNIT

Applicant Irom Imaging, Inc.

K number K010304

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IZL 2000-09-15

CORDLESS COMPACT MOBILE X-RAY SYSTEM

Applicant Medison Radiology Systems, Inc.

K number K002685

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IZL 2000-06-27

SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES

Applicant Shimadzu Corp.

K number K001517

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IZL 1999-08-06

MXU-125 OR TMX-125

Applicant Trex Medical Corp.

K number K992229

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IZL 1998-07-14

XR-910

Applicant Imaging Sciences Intl., Inc.

K number K981466

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IZL 1997-12-30

CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL

Applicant Dynarad Corp.

K number K973833

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IZL 1997-12-12

MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT

Applicant Minxray, Inc.

K number K973712

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IZL 1997-12-12

COMPACT OR COMP-X

Applicant Eurotec, S.R.L.

K number K972365

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IZL 1997-10-08

ACU-RAY HF SERIES PORTABLE X-RAY UNIT

Applicant Sterne Equipment Co., Ltd.

K number K972204

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IZL 1997-05-02

SEALED LEAD ACID BATTERY PACK

Applicant Portable Power Systems, Inc.

K number K970234

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IZL 1995-12-22

MOBILE X-RAY SYSTEM

Applicant Shimadzu Corp.

K number K955036

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IZL 1995-12-21

SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM

Applicant Sierra Battery, Inc.

K number K955095

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IZL 1995-11-30

OSTEO-RAY 100

Applicant Micro Focus Imaging, Inc.

K number K953404

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IZL 1995-11-22

CP 100/30

Applicant Micro-Focus Imaging., Inc.

K number K953292

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IZL 1995-03-14

GENERAL ELECTRIC AMX 110, AMX II AND AMX 3

Applicant Pro-Tronics, Inc.

K number K944442

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IZL 1995-01-20

BATTERY PACK #PMX120-18A

Applicant Portable Power Systems, Inc.

K number K945043

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IZL 1995-01-19

MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT

Applicant Minxray, Inc.

K number K945707

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IZL 1994-09-14

MOBILETT PLUS MOBILE X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K932106

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IZL 1994-07-20

PHANTOM

Applicant Dynarad Corp.

K number K941363

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IZL 1994-02-17

REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.

Applicant Portable Power Systems, Inc.

K number K931483

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IZL 1994-01-31

HF-110A

Applicant Dynarad Corp.

K number K932353

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IZL 1994-01-24

HAND HELD DENTAL X-RAY DEVICE

Applicant Dept. of the Army

K number K934818

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IZL 1993-11-03

ACU-RAY

Applicant Sterne Equipment Co., Ltd.

K number K931279

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IZL 1993-08-09

M6-M

Applicant X-Cel X-Ray Corp.

K number K930699

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IZL 1993-08-03

9150A, 1100F

Applicant Dynarad Corp.

K number K932355

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IZL 1993-07-23

9170, 1170

Applicant Dynarad Corp.

K number K932354

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IZL 1993-07-13

BATTERY PACKS (VARIOUS MODELS)

Applicant Access / God Loves You

K number K931200

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IZL 1993-06-22

INFRARED EXPOSURE HAND SWITCH

Applicant Mid X-Ray, Inc.

K number K930049

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IZL 1993-04-07

PORT-XP

Applicant Mobile Dental Equipment Corp.

K number K923359

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IZL 1992-10-16

BATTERY PACK

Applicant Portable Power Systems, Inc.

K number K924798

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IZL 1992-10-05

PX-100 PORTABLE X-RAY GENERATOR

Applicant Acoma Medical Imaging, Inc.

K number K921116

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IZL 1992-08-27

SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R

Applicant Acoma Medical Imaging, Inc.

K number K921425

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IZL 1991-09-09

VMX MOBILE X-RAY SYSTEM

Applicant GE Medical Systems

K number K910902

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IZL 1991-09-06

THE REMOTE

Applicant Remote Technologies, Inc.

K number K912323

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IZL 1991-08-26

MINXRAY P300 X-RAY SYSTEM

Applicant Minxray, Inc.

K number K911841

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IZL 1991-08-09

MOBILE X-RAY FLOOR STAND

Applicant Dntl Corp.

K number K912400

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IZL 1990-10-26

G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS

Applicant Electromek Diagnostic Systems, Inc.

K number K902984

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IZL 1990-07-02

GENERAL ELECTRIC AMX 3

Applicant Pro-Tronics, Inc.

K number K902610

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IZL 1989-12-14

RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT

Applicant Lorad Medical Systems, Inc.

K number K894643

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IZL 1989-09-01

MOBILE X-RAY UNIT

Applicant Ziehm International, Inc.

K number K894021

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IZL 1989-07-20

MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM

Applicant Shimadzu Medical Systems

K number K893637

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IZL 1989-05-03

GENERAL ELECTRIC AMX 110

Applicant Pro-Tronics, Inc.

K number K891143

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IZL 1989-05-01

GENERAL ELECTRIC AMX II

Applicant Pro-Tronics, Inc.

K number K891142

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IZL 1989-04-17

BCM-ARC 105 X-RAY MOBILE UNIT

Applicant B C Medical , Ltd.

K number K890306

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IZL 1988-10-13

BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR

Applicant Bennett X-Ray Corp.

K number K883092

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IZL 1988-02-22

PB-A LEAD-ACID BATTERY CONVERSION KIT

Applicant Diagnostic Imaging Specialists Corp.

K number K875106

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IZL 1988-01-11

BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A

Applicant Bennett X-Ray Corp.

K number K874840

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IZL 1987-10-30

GX-MOBILE X-RAY UNIT

Applicant Gendex Corp.

K number K873982

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IZL 1986-07-22

MX MOBILE X-RAY SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K862452

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IZL 1986-06-16

MODEL MBA-130 MOBILE X-RAY SYSTEM

Applicant Elscint, Inc.

K number K862118

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IZL 1985-04-18

AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL

Applicant Fairchild Medical Systems, Inc.

K number K850678

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IZL 1984-09-05

APR MOBILE

Applicant Philips Medical Systems (Cleveland), Inc.

K number K843192

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IZL 1983-11-21

PORTA. X-RAY UNIT FP220 SCM-1-ETC,

Applicant Showa X-Ray Co., Ltd.

K number K833239

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IZL 1983-10-28

PMX MOBILE X-RAY SYSTEM

Applicant Philips Medical Systems, Inc.

K number K833226

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IZL 1981-12-03

MOBIL-AID AUTOMATIC EXPOSURE CONTROL

Applicant Advanced Instrument Development, Inc.

K number K813128

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IZL 1981-05-21

BETA I & BETA II

Applicant Porta Ray, Inc.

K number K811082

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IZL 1981-03-11

ALPHA I AND ALPHA II

Applicant Porta Ray, Inc.

K number K810276

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