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
No recalls linked.
Regulatory clearances
Predicate lineage
- K193360
- K141440
- K142475
- K150725
- K151942
- K152172
- K160620
- K161730
- K162552
- K162555
- K171137
- K180332
- K182348
- K182550
- K182551
- K183286
- K183422
- K183713
Cited as predicate by: K231995
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 |
|---|---|---|---|---|
| 2023-11-16 | NAI | No action indicated | RadmediX LLC | 0 |
| 2023-11-16 | NAI | No action indicated | RadmediX LLC | 0 |
| 2019-04-16 | NAI | No action indicated | RadmediX LLC | 0 |
| 2019-04-16 | NAI | No action indicated | RadmediX LLC | 0 |
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