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Solid State X-Ray Imager (Flat Panel/Digital Imager)
FDA product code MQB · Class 2 · Radiology
1,716
Registered devices
1,282
Adverse events
195
Recalls
424
510(k) clearances
Devices with this code
1417WCA — Rayence Co., Ltd.D-EVO II G35 — FUJIFILM CORPORATIONSchick AE — SIRONA DENTAL, INC.XIOS XG SUPREME — SIRONA DENTAL, INC.SCHICK33 — SIRONA DENTAL, INC.Digital Flat Panel Detector — iRay GroupRadmedix AcuityDR 1717 G4 — RADMEDIX, LLCSEDECAL — SEDECALDigitalDiagnost — Philips Medical Systems DMC GmbHRadmedix AcuityDR 1417 G4 — RADMEDIX, LLCChiroSight Flat Panel and Software — Biokinemetrics, Inc.Schick — Dentsply International Inc.Schick — Dentsply International Inc.Nical Flat Panel — NICAL SPASchick — Dentsply International Inc.EXPD 4343S — DRTECH CorporationFDR D-EVOIII Battery Pack — FUJIFILM CORPORATIONTRIMAX 3543C Detector — CARESTREAM HEALTH, INC.FCR CARBON X — FUJIFILM CORPORATIONVilla Sistemi Medicali — VILLA SISTEMI MEDICALI SPAD-EVO II G43 — FUJIFILM CORPORATIONSchick — Dentsply International Inc.FONA STELLARIS — SIRONA DENTAL, INC.Schick AE — SIRONA DENTAL, INC.
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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