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.
No recalls linked.
- 510(k)K191928Substantially equivalent (SESE) · 2020-02-28clearance family
Predicate lineage
- K191928
Cited as predicate by: K193562, K202700, K203235, K203610, K212116, K212274, K213155, K220264, K221706, K223724, K230082, K231855, K231928
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.
None in the loaded window.
- AATMA Elekta Solutions AB
- AI-Rad Companion Organs RT Siemens Healthcare GmbH
- AI-Rad Companion Organs RT Siemens Healthcare GmbH
- AI-Rad Companion Organs RT Siemens Healthcare GmbH
- AI-Rad Companion Organs RT Siemens Healthcare GmbH
- AI-Rad Companion Organs RT Siemens Healthcare GmbH
- AI-Rad Companion Organs RT Siemens Healthcare GmbH
- ART-Plan THERAPANACEA
- ART-Plan THERAPANACEA
- ART-Plan THERAPANACEA
- AVIEW RT ACS CORELINE SOFT CO.,LTD.
- Auto Segmentation GE Medical Systems, L.L.C.