510(k) K032046 ยท OWB Interventional Fluoroscopic X-Ray System
PHILLIPS OMNIDIAGNOST ELEVA
| Applicant | Philips Medical Systems, Inc., Da Best, NL |
| Decision | Substantially Equivalent, Jul 17, 2003 |
| Received | Jul 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2019 | Philips North America, LLC OmniDiagnost Eleva System codes 708028
708027 Terminated |
OWB | None listed |
| Feb 28, 2019 | Philips North America, LLC URODiagnost Eleva, Product codes 708026, 708027, 708028
Product Usage:
The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide ran Terminated |
OWB | None listed |
| Jun 27, 2018 | Philips Medical Systems Nederlands OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028 Terminated |
JAA | None listed |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115. Terminated |
IZI | None listed |
| Jan 18, 2011 | Philips Medical Systems North America Co. Phillips Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system.
The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventiona Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips OminDiagnost Eleva Terminated |
JAA | None listed |
| Sep 16, 2008 | Philips Medical Systems North America Co. Phillips Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. Terminated |
IZI | None listed |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Omni Diagnost Eleva Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.