Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-02-06 | Z-1203-2023 | Class II | Open, Classified | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.Distribution: US, Argentina, Panama | 7 units | clearance family |
Regulatory clearances
- 510(k)K221803Substantially equivalent (SESE) · 2022-07-18clearance family
Predicate lineage
- K221803
Cited as predicate by: K223267
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-01-24 | OAI | Official action indicated | SEDECAL SA | 4 |
| 2013-06-28 | VAI | Voluntary action indicated | SEDECAL SA | 2 |
| 2010-01-15 | NAI | No action indicated | SEDECAL SA | 0 |
Similar devices
- Wireless Digital Flat Panel Detector iRay Group
- !M1 Solutions For Tomorrow AB
- 0909FCB Rayence Co., Ltd.
- 0909FCC Rayence Co., Ltd.
- 0909FCC-HS Rayence Co., Ltd.
- 0909FCE Rayence Co., Ltd.
- 0909FCE-HS Rayence Co., Ltd.
- 1012WCA Rayence Co., Ltd.
- 1012WCC Rayence Co., Ltd.
- 1012WGC Rayence Co., Ltd.
- 10X12 Cassette for CR Reader KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
- 1210SGA Rayence Co., Ltd.
Select up to two to place side-by-side with this device.