510(k) K140808 ยท LLZ System, Image Processing, Radiological
Q-STATION
| Applicant | Philips Ultrasound, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Apr 17, 2014 |
| Received | Apr 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2015 | Philips Ultrasound, Inc. Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391
Q-Station is application software intended to manage, view, analyze, and rep Terminated |
LLZ | None listed |
| Dec 16, 2014 | Philips Ultrasound, Inc. Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391.
Intended to manage, view, analyze Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.