510(k) K153022 ยท LLZ System, Image Processing, Radiological
Philips IntelliSpace Cardiovascular
| Applicant | Philips Medical Systems Nethrlands BV, Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Nov 18, 2015 |
| Received | Oct 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2025 | Philips Medical Systems Nederland B.V. IntelliSpace Cardiovascular, Software 8.0.0.4. Open, Classified |
LLZ | None listed |
| May 8, 2025 | Philips Medical Systems Nederland B.V. IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. Open, Classified |
LLZ | None listed |
| Feb 28, 2025 | Philips Medical Systems Nederland B.V. Philips IntelliSpace Cardiovascular software, Model 830089. Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.