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

K193644E-COM DR-2000 DRLiverMoreTech, Inc.
K193238Nexus DR Digital X-Ray Imaging System (with VSharp)Varex Imaging Corporation
K193173CareView 1800LeCareRay Digital Medical System Co., Ltd.
K193031EXPD 4343P, EXPD 3643PDRTECH Corporation
K193017EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WPDRTECH Corporation
K192932FDR D-EVO III Flat Panel Detector SystemFUJIFILM Corporation
K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessCanon, Inc.
K192512Focus 35C Detector, Trimax 35C DetectorIRay Technology Taicang Ltd.
K192440FDR SE LiteFujifilm Corporation
K192400EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AGDRTECH Corporation
K191939Yushan X-Ray Flat Panel DetectorInnoCare Optoelectronics Corp.
K191645SKR 4000Konica Minolta, Inc.
K190691Pixx2430 Digital Diagnostic X-Ray Receptor PanelPixxgen Corporation
K190611VIVIX-S 1751SVieworks Co., Ltd.
K190368Enhanced Feature Software Pack CXDI SeriesCanon, 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,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
2018-12-27
2018-12-27
2018-12-27

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