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)K170332Substantially equivalent (SESE) · 2017-03-01clearance family
Predicate lineage
- K170332
Cited as predicate by: K173517, K183541, K190368, K192011, K192632, K192936, K202293, K203849, K211542, K212515, K212553, K213780, K222339
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.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2014-09-19 | NAI | No action indicated | Canon Components, Inc. (Factory Site) | 0 |
| 2014-09-17 | NAI | No action indicated | Canon Inc. | 0 |
| 2014-09-17 | NAI | No action indicated | Canon Inc. | 0 |
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