Solid State X-ray Imager (flat Panel/digital Imager)

Product Code: MQB

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: 892.1680


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as MQB

5392Solid State X-ray Imager (flat Panel/digital Imager)Stationary X-ray System.

Total Product Life Cycle (TPLC) Devices

5392Solid State X-ray Imager (flat Panel/digital Imager)Stationary X-ray System.

FDA Consensus Standards

Solid State X-Ray Imager (Flat Panel/Digital Imager) [37593]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [28638]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [37630]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [33118]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [32777]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [37989]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [37990]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [34029]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [28640]21 CFR §892.1680 🔎
Solid State X-Ray Imager (Flat Panel/Digital Imager) [33117]21 CFR §892.1680 🔎

Pre-market Notifications for MQB

K221876Digital Radiography CXDI-Pro, Digital Radiography D1Canon Inc.
K221714Flat Panel DetectorIRay Technology Taicang Ltd.
K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.
K22146110HQ701G-BLG Electronics Inc.
K22143417HQ701G-BLG Electronics Inc.
K22139414HQ701G-BLG Electronics Inc.
K221345Wireless Digital Flat Panel DetectorIRay Technology Taicang Ltd.
K221144PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FGRadisen Co., Ltd
K220668Wireless Digital Flat Panel DetectorIRay Technology Taicang Ltd.
K22055917HQ901G-BLG Electronics Inc.
K220536Digital Flat Panel DetectorIRay Technology Taicang Ltd.
K220510Yushan X-Ray Flat Panel Detector With DROCInnoCare Optoelectronics Corp.
K220098Digital Radiography CXDI-Pro, Digital Radiography D1Canon Inc.
K21404414HQ901G-BLG Electronics Inc.
K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.

Global Unique Device Identification Database

00628451892021Solid State X-Ray Imager (Flat Panel/Digital Imager)
00754020100072Solid State X-Ray Imager (Flat Panel/Digital Imager)
00754020100065Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020214Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020184Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020177Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020160Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020153Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020139Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020122Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020108Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020092Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020085Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020078Solid State X-Ray Imager (Flat Panel/Digital Imager)
00812589020061Solid State X-Ray Imager (Flat Panel/Digital Imager)

Maude Adverse Events

HUT EXT DR FINAL ASSY,ST,FPDLIEBEL-FLARSHEIM2020-03-18
DIGITALDIAGNOST DUAL DETECTORPHILIPS MEDICAL SYSTEMS DMC GMBH2020-03-06
DIGITALDIAGNOST SINGLE DETECTORPHILIPS MEDICAL SYSTEMS DMC GMBH2020-01-23
HUT EXT DR FINAL ASSY,RE,FPDLIEBEL-FLARSHEIM2019-10-16
DRX-1 TRANSPORTABLE SYSTEMCARESTREAM HEALTH, INC.2019-10-02
DIGITALDIAGNOSTPHILIPS MEDICAL SYSTEMS DMC GMBH2019-09-17
DIGITALDIAGNOSTPHILIPS MEDICAL SYSTEMS DMC GMBH2019-09-17
DIGITALDIAGNOST DUAL DETECTORPHILIPS MEDICAL SYSTEMS DMC GMBH2019-08-27
DIGITALDIAGNOST 4.1 HIGH PERFORMANCEPHILIPS MEDICAL SYSTEMS DMC GMBH2019-08-20
DIGITALDIAGNOST DUAL DETECTORPHILIPS MEDICAL SYSTEMS DMC GMBH2019-08-14
HUT EXT DR FINAL ASSY,RE,FPDLIEBEL-FLARSHEIM2019-08-12
DR 400AGFA-GEVAERT HEALTHCARE GMBH2019-07-29
DIGITALDIAGNOST DUAL DETECTORPHILIPS MEDICAL SYSTEMS DMC GMBH2019-07-18
DIGITALDIAGNOST 4.1 HIGH PERFORMANCEPHILIPS MEDICAL SYSTEMS DMC GMBH2019-07-11
HUT EXT DR FINAL ASSY,ST,FPDLIEBEL-FLARSHEIM2019-06-19
HUT EXT DR FINAL ASSY,ST,FPDLIEBEL-FLARSHEIM2019-06-14
HUT EXT DR FINAL ASSY,RE,FPDLIEBEL-FLARSHEIM2019-05-21
DIGITALDIAGNOST DUAL DETECTORPHILIPS MEDICAL SYSTEMS DMC GMBH2019-05-16
FDR D-EVO SUITE IIFUJIFILM CORPORATION2019-05-10
FDR D-EVO SUITE IIFUJIFILM CORPORATION2019-05-10
DIGITALDIAGNOST VMPHILIPS MEDICAL SYSTEMS DMC GMBH2019-05-10
UROSKOP OMNIA MAXSIEMENS HEALTHCARE GMBH2019-04-23
DIGITALDIAGNOST 4 HIGH PERFORMANCEPHILIPS MEDICAL SYSTEMS DMC GMBH2019-04-17
DIGITALDIAGNOST 4.1 HIGH PERFORMANCEPHILIPS MEDICAL SYSTEMS DMC GMBH2019-04-10
DIGITALDIAGNOST 3.1.XPHILIPS MEDICAL SYSTEMS DMC GMBH2019-04-09
DIGITALDIAGNOST 4.1 HIGH PERFORMANCEPHILIPS MEDICAL SYSTEMS DMC GMBH2019-02-21
2019-01-15
2019-01-15
2019-01-15
2019-01-15
2019-01-08
2019-01-08
2019-01-08
2019-01-08
2019-01-08
2019-01-03
2019-01-03
2019-01-03
INFIMED, NEXUS IMAGE PROC SYSLIEBEL-FLARSHEIM2019-01-03
2019-01-03
2019-01-03
2019-01-03
2019-01-03
2018-12-31
2018-12-31
2018-12-31
2018-12-31
2018-12-28
2018-12-27
2018-12-27

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