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
- 510(k)K232899Substantially equivalent (SESE) · 2024-04-03clearance family
Predicate lineage
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 |
|---|---|---|---|---|
| 2014-09-25 | NAI | No action indicated | Siemens AG/Siemens Healthcare GmbH | 0 |
| 2011-06-09 | VAI | Voluntary action indicated | Siemens Healthcare GmbH | 1 |
| 2010-09-14 | NAI | No action indicated | Siemens AG/Siemens Healthcare GmbH | 0 |
Similar devices
- AATMA Elekta Solutions AB
- ART-Plan THERAPANACEA
- ART-Plan THERAPANACEA
- ART-Plan THERAPANACEA
- ARTAssistant Manteia Technologies Co.,Ltd.
- AVIEW RT ACS CORELINE SOFT CO.,LTD.
- AccuContour Manteia Technologies Co.,Ltd.
- AccuContour Manteia Technologies Co.,Ltd.
- AccuContour Manteia Technologies Co.,Ltd.
- AccuContour Manteia Technologies Co.,Ltd.
- Auto Segmentation GE Medical Systems, L.L.C.
- AutoContour Radformation, Inc
Select up to two to place side-by-side with this device.