510(k) K191647 ยท QIH Automated Radiological Image Processing Software
QLAB Advanced Quantification Software
| Applicant | Philips Health Care, Bothell WA, US |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Jun 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191647
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.