510(k) K050151 ยท KPR System, X-Ray, Stationary
MULTIDIAGNOST ELEVA
| Applicant | Philips Medical Systems North America, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Feb 9, 2005 |
| Received | Jan 24, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050151
| 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 18, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost E Open, Classified |
KPR | None listed |
| Sep 14, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems Open, Classified |
OWB | 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 w/ Flat Detector, Product codes 708034, 708037, 708038
Product Usage:
As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiog Terminated |
KPR | None listed |
| Feb 19, 2019 | Philips Medical Systems Nederlands Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038
Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, Terminated |
IZI | None listed |
| Feb 19, 2019 | Philips Medical Systems Nederlands Foot Switches used with the following systems:
722001 Allura Xper FD 10 C
722002 Allura Xper FD10 F
722003 Allura Xper FD10
722005 Allura Xper FD10/10
722006 Allura Xper FD20
722008 Allura Xper FD2 Terminated |
IZI | None listed |
| May 3, 2018 | Philips Medical Systems Nederlands MultiDim Eleva 708032
As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional ap Terminated |
KPR | None listed |
| May 3, 2018 | Philips Medical Systems Nederlands Mutlidiagnost-Eleva with Flat Detector 708034
As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more special Terminated |
KPR | None listed |
| May 3, 2018 | Philips Medical Systems Nederlands Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037
As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Perform Terminated |
KPR | None listed |
| May 3, 2018 | Philips Medical Systems Nederlands MultiDiagnostic-Eleva with Flat Detector 708038
As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more speci Terminated |
KPR | None listed |
| May 3, 2018 | Philips Medical Systems Nederlands MultiDiagnostic-Eleva with Flat Detector 708035
As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more speci Terminated |
KPR | None listed |
| Feb 26, 2015 | Philips Medical Systems, Inc. Philips Multi Diagnost Eleva with FlatDetector Terminated |
IZI | None listed |
| Sep 24, 2014 | Philips Medical Systems, Inc. Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038
This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. Gen Terminated |
KPR | None listed |
| Sep 24, 2014 | Philips Medical Systems, Inc. Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper Terminated |
IZI | None listed |
| Aug 8, 2012 | Philips Healthcare Inc. Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034
Product Usage:
Philips X-ray System Terminated |
KPR | 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 |
| Feb 2, 2012 | Philips Healthcare Inc. Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1
Product Code 708037
Product Usage:
The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. Ge Terminated |
IZI | None listed |
| Sep 25, 2009 | Philips Medical Systems North America Co. Phillips Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher
Used for general R/F, fluoroscopy, radiography, and angiography examinations. Terminated |
KPR | None listed |
| May 28, 2008 | Philips Medical Systems North America Co. Phillips MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems,
Bothell, WA, 98021 Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.