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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 2026-08-03

XLITE

Applicant GEMSS HEALTHCARE CO., LTD.

K number K260236

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IZL 2026-06-18

Portable DR Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd.

K number K253058

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IZL 2026-05-14

RAYMO Mobile X-ray System (Model: RAYMO)

Applicant DRGEM Corporation

K number K260085

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IZL 2026-03-11

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

Applicant Carestream Health

K number K253185

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IZL 2026-02-23

AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

Applicant Poskom Co., Ltd.

K number K253244

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IZL 2025-12-19

Airbile-100

Applicant Poskom Co., Ltd.

K number K250976

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IZL 2025-10-24

Mobile X-ray unit (!M1)

Applicant Solutions For Tomorrow AB

K number K251710

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IZL 2025-09-12

BONX805

Applicant Bontech Co., Ltd.

K number K243864

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IZL 2025-08-22

PROMO

Applicant DRGEM Corporation

K number K251443

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IZL 2025-08-04

HnX-P1, HnX-PB

Applicant H&abyz Co., Ltd.

K number K251223

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IZL 2025-07-31

REMEX Xcam6

Applicant Remedi, Inc.

K number K250597

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IZL 2025-07-29

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS

Applicant Prognosys Medical Systems Private Limited

K number K243473

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IZL 2025-07-18

INNOVISION-P5

Applicant Dk Medical Systems Co., Ltd.

K number K250750

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IZL 2025-05-28

Europa (Alternative: AiRTouch) portable X-ray system

Applicant Livermoretech, Inc.

K number K244049

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IZL 2025-05-06

!M1

Applicant Solutions For Tomorrow AB

K number K241980

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IZL 2025-04-18

ULTRA 1040

Applicant Ecoray Co., Ltd.

K number K241996

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IZL 2024-12-16

TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

Applicant DRGEM Corporation

K number K242015

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IZL 2024-12-10

DRX-Revolution Mobile X-ray System

Applicant Carestream Health, Inc.

K number K241505

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IZL 2024-12-09

Digital Radiography System (ManntiX B, ManntiX K)

Applicant Shenzhen Browiner Tech Co., Ltd.

K number K240841

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IZL 2024-10-10

uDR 380i Pro

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K242515

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IZL 2024-10-01

GM85

Applicant Samsung Electronics Co., Ltd.

K number K242651

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IZL 2024-09-20

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)

Applicant Energy Resources International Co., Ltd.

K number K234108

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IZL 2024-07-03

iQFlex Pro

Applicant First Source, Inc.

K number K240009

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IZL 2024-03-28

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)

Applicant Shenzhen Browiner Tech Co., Ltd.

K number K240284

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IZL 2024-02-14

Radiography 7000 M

Applicant Philips Medical Systems Dmc GmbH

K number K233678

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IZL 2023-08-21

SM-IV

Applicant Sedecal., Sa.

K number K232185

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IZL 2023-08-16

TOPA12 Portable X-ray Unit

Applicant Neuf, Inc.

K number K230581

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IZL 2023-07-25

MOBILETT Impact

Applicant Siemens Medical Solutions

K number K231577

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IZL 2022-12-20

AirRay

Applicant Poskom Co., Ltd.

K number K222896

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IZL 2022-11-21

SM-V

Applicant Sedecal., Sa.

K number K222951

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IZL 2022-11-01

Combined High Frequency X-ray Source

Applicant Suzhou Powersite Electric Co., Ltd.

K number K222258

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IZL 2022-09-30

uDR 380i Pro

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K222339

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IZL 2022-09-29

GM85

Applicant Samsung Electronics Co., Ltd.

K number K222353

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IZL 2022-09-13

CLAROX plus (Model: VX-100)

Applicant Vsi Co., Ltd.

K number K221417

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IZL 2022-07-18

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.

Applicant Sedecal., Sa.

K number K221803

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IZL 2022-07-10

MINE ALNU (Model: Mine 2.1)

Applicant Hdt Co., Ltd.

K number K213405

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IZL 2022-06-13

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System

Applicant First Source, Inc.

K number K221081

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IZL 2022-05-04

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine

Applicant Yian Medical Technology (Haining) Co., Ltd.

K number K220700

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IZL 2022-04-21

GM85

Applicant Samsung Electronics Co., Ltd.

K number K220175

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IZL 2022-03-31

APX-24 Portable X-ray System

Applicant Aspenstate, Inc.

K number K220678

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IZL 2022-03-23

DRX-Rise Mobile X-ray System

Applicant Carestream Health

K number K213568

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IZL 2022-03-04

Skanmobile, Skanmobile-Dr

Applicant Skanray Technologies Limited

K number K212940

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IZL 2022-02-11

EzRay M18 (Model: VMX-P400)

Applicant VATECH Co., Ltd.

K number K213462

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IZL 2022-02-04

Micro C Medical Imaging System, M01

Applicant Oxos Medical, Inc.

K number K212654

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IZL 2021-11-03

MOVIX DReamy

Applicant Stephanix

K number K212515

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IZL 2021-09-14

PHOENIX

Applicant Sedecal., Sa.

K number K212291

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IZL 2021-08-25

Diagnostic X-ray System/PLX5200A

Applicant Nanjing Perlove Medical Equipment Co., Ltd.

K number K212134

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IZL 2021-08-13

NFLK-2501 Portable X-ray Unit

Applicant Neuf, Inc.

K number K211383

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IZL 2021-08-03

Remex KA6

Applicant Remedi Co., Ltd.

K number K212144

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IZL 2021-06-04

Micro C Medical Imaging System, M01

Applicant Oxos Medical, Inc.

K number K211473

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IZL 2021-05-21

Rover

Applicant Micro-X Limited

K number K211423

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IZL 2021-04-28

AMX Navigate

Applicant Ge Medical Systems, LLC

K number K210982

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IZL 2021-04-01

Nanox Cart X-ray System

Applicant Nano-X Imaging , Ltd.

K number K203782

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IZL 2021-03-19

IMPACT and X-Ranger

Applicant Minxray, Inc.

K number K210479

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IZL 2021-02-02

EzRay M (Model: VMX-P300)

Applicant VATECH Co., Ltd.

K number K203667

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IZL 2021-01-12

Micro C Medical Imaging System, M01

Applicant Oxos Medical, Inc.

K number K203658

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IZL 2021-01-06

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K number K202350

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IZL 2020-12-23

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K number K202353

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IZL 2020-07-17

Rover

Applicant Micro-X , Ltd.

K number K201488

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IZL 2020-07-09

SR-8100 Portable X-ray Unit

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K number K200637

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IZL 2020-07-08

CMDR 2C (Multiple Models)

Applicant Minxray, Inc.

K number K201575

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IZL 2020-06-19

AQUILA 320 D / AQUILA 320 S

Applicant Vmi Tecnologias Ltda

K number K201340

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IZL 2020-06-10

SR-8230, SR-8230S Portable X-ray Unit

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K number K200976

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IZL 2020-05-19

TOPAZ Mobile DR System

Applicant DRGEM Corporation

K number K201124

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IZL 2020-05-07

EZER, Portable X-ray System

Applicant Livermoretech, Inc.

K number K193535

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IZL 2020-04-13

AcuityPDR

Applicant Radmedix, LLC

K number K200726

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IZL 2019-11-15

Soltus 500

Applicant Sedecal., Sa.

K number K192936

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IZL 2019-09-25

PhoeniX

Applicant Sedecal., Sa.

K number K192011

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IZL 2019-08-09

DR 100s

Applicant Agfa N.V.

K number K191884

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IZL 2019-08-02

MobileDiagnost wDR 2.2

Applicant Sedecal., Sa.

K number K191813

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IZL 2019-07-03

CMDR 2CW (Multiple models)

Applicant Minxray, Inc.

K number K191451

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IZL 2019-05-17

DRX-Revolution Mobile X-ray System

Applicant Carestream Health, Inc.

K number K191025

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IZL 2019-05-15

Topaz Mobile DR System

Applicant DRGEM Corporation

K number K183292

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IZL 2019-03-15

MOBILETT Elara Max

Applicant Siemens Medi Cal Solutions, Inc.

K number K182639

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IZL 2019-02-05

JADE Mobile X-Ray

Applicant DRGEM Corporation

K number K183388

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IZL 2018-12-14

TR90BH

Applicant Minxray, Inc.

K number K182207

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IZL 2018-09-24

AMADEO M-DR mini, AMADEO M-AX mini

Applicant Oehm Und Rehbein GmbH

K number K182317

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IZL 2018-09-14

MX40 Mobile Digital X-ray System

Applicant Huestis Machine Corporation

K number K181874

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IZL 2018-09-06

Optima XR240amx

Applicant Ge Medical Systems, LLC

K number K182234

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IZL 2018-07-20

Digital Diagnostic Mobile X-ray System

Applicant Samsung Electronics Co., Ltd.

K number K181626

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IZL 2018-02-05

DRX-Revolution Nano Mobile X-ray System

Applicant Carestream Health, Inc.

K number K173924

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IZL 2018-01-26

DRAGON X SPSL4HC, DRAGON X SPSL8HC

Applicant Sedecal., Sa.

K number K173299

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IZL 2018-01-12

Optima XR240amx, AutoGrid

Applicant Ge Medical Systems, LLC

K number K173602

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IZL 2017-11-20

MDR17 Mobile Direct Radiographic System

Applicant Del Medical, Inc.

K number K173018

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IZL 2017-11-16

MobileDiagnost M50

Applicant Philips India Limited

K number K173187

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IZL 2017-07-17

!M1

Applicant Solutions For Tomorrow AB

K number K170607

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IZL 2017-06-21

DRX-Revolution Nano Mobile X-ray System

Applicant Carestream Health, Inc.

K number K170755

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IZL 2017-06-07

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris

Applicant Minxray, Inc.

K number K171353

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IZL 2017-05-12

GM85

Applicant Samsung Electronics Co., Ltd.

K number K171119

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IZL 2017-04-24

FDR AQRO (DR-XD 1000)

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

K number K170858

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IZL 2016-12-12

UC-5000 Mobile X-Ray

Applicant Source-Ray, Inc.

K number K163063

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IZL 2016-11-15

Optima XR240amx

Applicant Ge Medical Systems, LLC

K number K162990

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IZL 2016-11-15

Digital Diagnostic Mobile X-ray System

Applicant Samsung Electronics Co., Ltd.

K number K162278

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IZL 2016-10-21

Paragon 2

Applicant Meridian Medical Systems, LLC

K number K162687

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IZL 2016-07-06

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

Applicant Sedecal., Sa.

K number K161345

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IZL 2016-02-02

HF1202H PowerPlus Portable X-ray Equipment

Applicant Minxray, Inc.

K number K153059

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IZL 2012-10-05

PORTA 100HF

Applicant Job Corporation

K number K122697

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IZL 2012-08-02

DRAGON LW

Applicant Sedecal., Sa.

K number K121410

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IZL 2012-04-13

DRX-REVOLUTION MOBILE X-RAY SYSTEM

Applicant Carestream Health, Inc.

K number K120062

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IZL 2011-09-19

MOBILETT MIRA

Applicant Siemens Medical Solutions USA, Inc.

K number K111912

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