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.
Predicate lineage
Cited as predicate by: K101149, K101874, K101878, K103649, K103677, K110870, K110943, K111582, K122114, K123564, K141459, K142443, K254021
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 |
|---|---|---|---|---|
| 2017-12-06 | VAI | Voluntary action indicated | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC | 2 |
- A-scan probe NIDEK CO.,LTD.
- C60XI/5-2 MHZ FUJIFILM SONOSITE, INC.
- HITACHI, LTD. HITACHI, LTD.
- HITACHI, LTD. HITACHI, LTD.
- Lumify Diagnostic Ultrasound System Philips Ultrasound LLC
- TEE ESAOTE SPA
- Transducer V6-2 Philips Ultrasound LLC
- "MyLabSeven LCD 19""" ESAOTE SPA
- 1 MHz Monitoring Adapter Compumedics Germany GmbH
- 1 MHz probe, handheld Compumedics Germany GmbH
- 1 MHz probe, handheld Compumedics Germany GmbH
- 1 MHz probe, monitoring Compumedics Germany GmbH