510(k) K982993 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS OMNIDIAGNOST
| Applicant | Philips Medical Systems, Inc., Da Best, NL |
| Decision | Substantially Equivalent, Sep 29, 1998 |
| Received | Aug 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982993
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2019 | Philips North America, LLC Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025
Product Usage:
The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs Terminated |
JAA | None listed |
| Jun 27, 2018 | Philips Medical Systems Nederlands OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025 Terminated |
OWB | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips OmniDiagnost Terminated |
JAA | None listed |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America OmniDiagnost System Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.