510(k) K031535 ยท KPR System, X-Ray, Stationary
PHILIPS EASYDIAGNOST ELEVA
| Applicant | Philips Medical Systems North America Co., Bothell WA, US |
| Decision | Substantially Equivalent, Jun 17, 2003 |
| Received | May 16, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2023 | Philips North America Llc EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | None listed |
| Jul 10, 2020 | Philips North America, LLC EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose. Terminated |
JAA | None listed |
| Jul 14, 2017 | Philips Electronics North America Corporation Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector w Terminated |
KPR | None listed |
| Aug 19, 2014 | Philips Medical Systems, Inc. Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050 Terminated |
KPR | None listed |
| Dec 2, 2013 | Philips Medical Systems, Inc. Easy Diagnost Eleva
Universal Fluoroscopic applications Terminated |
KPR | None listed |
| Feb 1, 2013 | Philips Healthcare Inc. Phillips Easy Diagnost Eleva DRF. Model Number: 706034
Product Usage:
Universal Fluoroscopic Applications Terminated |
KPR | None listed |
| Aug 15, 2012 | Philips Healthcare Inc. Philips Easy Diagnost Classic-Stationary x-ray system
Catalog Numbers: 70642, 70643, 706030, 706031, 706032
Stationary x-ray system, Universal RF system for general use. Terminated |
IXR | None listed |
| Jun 18, 2012 | Philips Healthcare Inc. Philips Easy Diagnost
Product Usage: Stationary Fluoroscopic system Terminated |
IXR | None listed |
| Mar 23, 2012 | Philips Medical Systems Gmbh, DMC Philips Easy Diagnost Eleva DRF, Software release 4.0
Fluoroscopic image-intensified Stationary X-Ray System. Terminated |
JAA | None listed |
| Mar 15, 2012 | Philips Healthcare Inc. Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system
Software Release 3.0 and 3.1
Model: 706034
Product Usage: Radiological image processing system (computed radiography x-ray system) Terminated |
KPR | None listed |
| Jan 18, 2011 | Philips Medical Systems North America Co. Phillips Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system.
The Philips EasyDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/univers Terminated |
IZI | None listed |
| Nov 26, 2010 | Philips Medical Systems North America Co. Phillips Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany. Terminated |
KPR | None listed |
| Aug 10, 2010 | Philips Medical Systems North America Co. Phillips The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system. Terminated |
KPR | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips EasyDiagnost Eleva x-ray systems Terminated |
JAA | None listed |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Easy Diagnost Eleva Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.