510(k) K132165 ยท LLZ System, Image Processing, Radiological
QLAB QUANTIFICATION SOFTWARE
| Applicant | Philips Ultrasound, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Aug 9, 2013 |
| Received | Jul 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132165
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Philips Ultrasound, Inc. Additional devices identified in new FSN MA-FCO 83000190:
QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips
Xcelera software.
************************************************ Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.