510(k) K141736 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
| Applicant | Philips Medical Systems Dmc GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Jul 25, 2014 |
| Received | Jun 27, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2018 | Philips Medical Systems Gmbh, DMC Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System
Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228. Terminated |
MQB | None listed |
| Dec 11, 2017 | Philips Electronics North America Corporation digital x-ray detector
ProGrade R1 - solid state X ray imager (flat panel/digital imager)
As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, an Terminated |
MQB | None listed |
| May 11, 2017 | Philips Electronics North America Corporation Philips DigitalDiagnost 3.1.x X-Ray System Terminated |
MQB | None listed |
| Jun 3, 2016 | Philips Healthcare Philips Healthcare DigitalDiagnost stationary X-ray system Terminated |
MQB | None listed |
| May 19, 2015 | Philips Medical Systems, Inc. Philips Healthcare DigitalDiagnost System X-Ray Terminated |
MQB | None listed |
| Mar 23, 2015 | Philips Electronics North America Corporation Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1
Product Usage:
The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qual Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.