Home › Device types › MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
FDA product code MQB · Class 2 · Radiology
1,686
Registered devices
1,277
Adverse events
195
Recalls
424
510(k) clearances
Devices with this code
Digital flat panel detector — iRay GroupFocus 35C Detector — CARESTREAM HEALTH, INC.FLAATZ — DRTECH Corporation0909FCC — Rayence Co., Ltd.XIOS AE — SIRONA DENTAL, INC.14X17 Portable GOS Flat Panel Detector without USB — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.LG — LG Electronics Inc.Digital Flat Panel Detector — iRay GroupDocking stand — FUJIFILM CORPORATIONMano2530A Wireless Digital Flat Panel Detector — iRay Group10X12 Cassette for CR Reader — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.X-ray Flat Panel Detector — CareRay Digital Medical Technology Co., Ltd.1717WCC — Rayence Co., Ltd.X-ray Flat Panel Detectors — CareRay Digital Medical Technology Co., Ltd.VIVIX-S 4343VAW — VIEWORKS CO., LTD.DR-ID 602SE — FUJIFILM CORPORATIONVarex Digital Imaging Software, Nexus DR, v4.15 — VAREX IMAGING CORPORATIONDRGEM — DRGEM CorporationSEDECAL — SEDECALSchick AE — SIRONA DENTAL, INC.X3C 2200 Digital Radiographic System — Imaging Dynamics Company LtdSchick33 — SIRONA DENTAL, INC.DR-ID 1212SE — FUJIFILM CORPORATIONPEDRA — Radisen Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-01 | Philips North America Llc | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. |
| 2023-05-19 | Philips North America Llc | There is a software login in issue that may prevent the user from logging in. |
| 2021-09-22 | Philips Healthcare | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This incl |
| 2021-03-11 | LIEBEL-FLARSHEIM COMPANY LLC | Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate |
| 2021-02-05 | Canon Medical System, USA, INC. | The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. |
| 2020-12-08 | Canon Medical System, USA, INC. | System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. |
| 2020-04-06 | Siemens Medical Solutions USA, Inc | It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pre |
| 2020-03-03 | Canon Medical System, USA, INC. | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. |
| 2020-01-07 | Palodex Group Oy | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which m |
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