System, X-ray, Mobile

Product Code: IZL

Radiology Medical Diagnostic X-Ray Equipment

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1720


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as IZL

5344System, X-ray, MobileMobile X-ray System.

Total Product Life Cycle (TPLC) Devices

5344System, X-ray, MobileMobile X-ray System.

FDA Consensus Standards

System, X-Ray, Mobile [37593]21 CFR §892.1720 🔎
System, X-Ray, Mobile [37630]21 CFR §892.1720 🔎
System, X-Ray, Mobile [32778]21 CFR §892.1720 🔎
System, X-Ray, Mobile [33118]21 CFR §892.1720 🔎
System, X-Ray, Mobile [32777]21 CFR §892.1720 🔎

Pre-market Notifications for IZL

K212515MOVIX DReamyStephanix
K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.
K211473Micro C Medical Imaging System, M01OXOS Medical, Inc.
K211423RoverMicro-X Limited
K211383NFLK-2501 Portable X-ray UnitNEUF Inc.
K210982AMX NavigateGE Medical Systems, LLC
K210479IMPACT And X-RangerMinXray, Inc.
K203782Nanox Cart X-ray SystemNano-x Imaging Ltd.
K203658Micro C Medical Imaging System, M01OXOS Medical, Inc.
K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI)
K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI)
K201575CMDR 2C (Multiple Models)MinXray, Inc
K201488RoverMicro-X Ltd.
K201340AQUILA 320 D / AQUILA 320 SVMI Tecnologias LTDA
K201124TOPAZ Mobile DR SystemDRGEM Corporation

Global Unique Device Identification Database

00458237384007System, X-Ray, Mobile
00817100020353System, X-Ray, Mobile
00817100020124System, X-Ray, Mobile
00817100020117System, X-Ray, Mobile
00868162000289System, X-Ray, Mobile
00868162000272System, X-Ray, Mobile
00868162000265System, X-Ray, Mobile
00868162000258System, X-Ray, Mobile
00868162000241System, X-Ray, Mobile
00868162000234System, X-Ray, Mobile
00867538000304System, X-Ray, Mobile
00861050000323System, X-Ray, Mobile
00861050000316System, X-Ray, Mobile
00861050000309System, X-Ray, Mobile
00860290000346System, X-Ray, Mobile

Maude Adverse Events

SYSTEM, X-RAY, MOBILECARESTREAM HEALTH, INC.2020-03-27
!M1!M1 MODELONESOLUTIONS FOR TOMORROW AB2020-03-09
2020-02-19
OPTIMA PORTABLE RADIOLOGY MACHINEGE MEDICAL SYSTEMS, LLC2020-02-10
PORTABLE X-RAY MACHINEGE2020-02-07
FDR AQROFUJIFILM CORPORATION2020-02-07
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2020-01-30
GM85SAMSUNG ELECTRONICS CO., LTD.2020-01-20
MEDTRONIC NAVIGATIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-01-09
MOBILETT ELARA MAXSIEMENS HEALTHCARE GMBH2020-01-06
DRX-REVOLUTION MOBILE X-RAY SYSTEMCARESTREAM HEALTH INC.2019-11-06
OPTIMA XR240AMXGE MEDICAL SYSTEMS, LLC2019-10-24
MEDTRONIC NAVIGATIONMEDTRONIC NAVIGATION, INC (LITTLETON)2019-10-02
MOBILETT MIRA MAXSIEMENS HEALTHCARE GMBH2019-09-25
OPTIMAGE MEDICAL SYSTEMS, LLC2019-09-23
OPTIMAGE MEDICAL SYSTEMS, INC.2019-09-16
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-08-30
AMX-4 PLUS MOBILE X-RAY SYSTEMGE MEDICAL SYSTEMS, LLC2019-08-21
MOBILETT ELARA MAXSIEMENS S.A.2019-08-12
OPTIMA XR200GE MEDICAL SYSTEMS, LLC2019-07-29
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-07-26
CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEMCARESTREAM HEALTH INC2019-07-25
MOBILETT XP HYBRIDSIEMENS HEALTHCARE GMBH2019-07-22
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-07-11
PHILIPS PORTABLE X-RAY MOBILE DIAGNOST WDR RELEASE 2PHILIPS2019-06-21
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-06-18
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-05-06
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-04-30
MOBILETT XP HYBRIDSIEMENS HEALTHCARE GMBH2019-04-23
MOBILETT MIRA MAXSIEMENS HEALTHCARE GMBH2019-04-19
MOBILETT MIRA MAXSIEMENS HEALTHCARE GMBH2019-04-17
MOBILETT MIRA MAXSIEMENS HEALTHCARE GMBH2019-04-17
AMX-4 PLUS MOBILE X-RAY SYSTEMGE MEDICAL SYSTEMS2019-04-10
MOBILETT XP HYBRIDSIEMENS HEALTHCARE GMBH2019-03-27
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-03-19
OPTIMA XR240AMXGE MEDICAL SYSTEMS, LLC2019-03-14
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-02-27
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-01-25
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-01-22
CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEMCARESTREAM HEALTH INC2019-01-16
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-01-09
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-01-09
MOBILEDIAGNOST WDR REL. 22019-01-09
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2019-01-09
MOBILE DIAGNOSTIC WDRPHILIPS MEDICAL SYSTEMS, INC.2018-12-12
O-ARM IMAGING SYSTEM2018-11-19
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA N.V.2018-11-13
DRX-REVOLUTION MOBILE X-RAY SYSTEMCARESTREAM HEALTH, INC2018-10-31
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100AGFA HEALTHCARE N.V.2018-10-19
PHILIPSSEDECAL SA2018-10-19

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