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)K220783Substantially equivalent (SESE) · 2022-09-07clearance family
Predicate lineage
Cited as predicate by: K232000, K232799, K232856, K232899, K252304
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
- .decimal Astroid Dosimetry App DECIMAL, INC.
- .decimal Astroid Planning App 3.x DECIMAL, INC.
- .decimal P.D DECIMAL, INC.
- .decimal Proton Shell and Lid Assembly DECIMAL, INC.
- 3D Bolus Application Adaptiiv Medical Technologies Inc
- 3D Bolus Software Adaptiiv Medical Technologies Inc
- 3D Brachy Application Adaptiiv Medical Technologies Inc
- ARIA Radiation Therapy Management VARIAN MEDICAL SYSTEMS, INC.
- ART-Plan THERAPANACEA
- ART-Plan THERAPANACEA
- ART-Plan THERAPANACEA
- Accuray Precision Treatment Planning System Accuray Incorporated
Select up to two to place side-by-side with this device.