510(k) K023441 ยท IZI System, X-Ray, Angiographic
PHILIPS MULTIDIAGNOST ELEVA
| Applicant | Philips Medical Systems, Best, NL |
| Decision | Substantially Equivalent, Oct 30, 2002 |
| Received | Oct 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips MultiDiagnost Eleva with the following Model Numbers:
Model # 708032 for MultiDiagnost Eleva;
Model # 708034 for MultiDiagnost Eleva with Flat Detector;
Model # 708036 for MultiDiagnost Eleva Open, Classified |
IZI | None listed |
| Sep 7, 2023 | Philips Medical Systems Nederland B.V. MultiDiagnost-Eleva Open, Classified |
KPR | None listed |
| Dec 30, 2019 | Philips North America, LLC MultiDiagnost Eleva, System codes 722030
722016
722017
708032
708036
708034
708037
708038 Terminated |
IZI | None listed |
| Feb 28, 2019 | Philips North America, LLC MultiDiagnost-Eleva, Product codes 708032, 708036
Product Usage:
As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed al Terminated |
IZI | None listed |
| May 3, 2018 | Philips Medical Systems Nederlands MultiDiagnost Eleva 708036
As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional Terminated |
IZI | None listed |
| Jul 19, 2016 | Philips Electronics North America Corporation MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038. Terminated |
IZI | None listed |
| Jul 19, 2016 | Philips Electronics North America Corporation MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036 Terminated |
IZI | None listed |
| Feb 26, 2015 | Philips Medical Systems, Inc. Philips Multi Diagnost Eleva II Terminated |
IZI | None listed |
| Jun 20, 2012 | Philips Healthcare Inc. Philips Multi Diagnost Eleva II with swivel cable
Product Codes;
708032, 708036
Multi Diagnost Eleva with FlatDetector with swivel cable
Product Codes: 708034, 708037
This Philips MultiDiagnost Eleva Terminated |
IZI | None listed |
| Mar 9, 2012 | Philips Medical Systems Nederlands Philips MultiDiagnost Eleva II Software Version R4.1.x
Model: 708032
This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Terminated |
IZI | None listed |
| Mar 9, 2012 | Philips Medical Systems Nederlands Philips MultiDiagnost Eleva FD, Software R5.1.x
Model: 708034
Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography Terminated |
IZI | None listed |
| Feb 8, 2012 | Philips Healthcare Inc. MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1
Product Code 708036
Product Usage:
The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal sy Terminated |
IZI | None listed |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO 70800114. Terminated |
IZI | None listed |
| Jan 18, 2011 | Philips Medical Systems North America Co. Phillips Philips MultiDiagnost Eleva with Digital Image (DI) Rel.2 system.
The Philips MultiDiagnost Eleva is intended use as a multi-functional universal system, general RF, Fluoroscopy, Radiography and Angi Terminated |
IZI | None listed |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Multi 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.