510(k) K982795 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
PHILIPS BUCKY VISION
| Applicant | Philips Medical Systems, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Nov 24, 1998 |
| Received | Aug 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2014 | Philips Medical Systems, Inc. Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85 Terminated |
MQB | None listed |
| Aug 26, 2013 | Philips Healthcare Inc. Philips Easy Upgrade DR, Code No: 712086
This system is used for making X-Ray exposures for diagnostics. Terminated |
KPR | None listed |
| Jun 17, 2013 | Philips Healthcare Inc. Philips Diagnost Stationary Radiographic System
Models:
712020, 712022, 712050, 712052, 712055, 712057, 712062
Product Usage:
Universal RAD Applications Terminated |
MQB | None listed |
| Jun 17, 2013 | Philips Healthcare Inc. Philips Diagnost Stationary Radiographic System
Models:
712020, 712022, 712050, 712052, 712055, 712057, 712062
Product Usage:
Universal RAD Applications Terminated |
MQB | None listed |
| Mar 1, 2013 | Philips Healthcare Inc. Philips Digital Diagnost
Stationary radiographic system Terminated |
MQB | None listed |
| Feb 26, 2013 | Philips Healthcare Inc. Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3
Model numbers 712020, 712022, and 712082
Product Usage:
Digital radiographic system Terminated |
MQB | None listed |
| Dec 5, 2012 | Philips Healthcare Inc. Philips Digital Diagnost Software Version R2.0.2
Product Usage:
This system is used for making X-ray exposures for diagnostics Terminated |
MQB | None listed |
| Sep 28, 2012 | Philips Healthcare Inc. Philips Digital Diagnost with patient carriage
Model: 712050 with serial number range from 00 000 00 to 09 000 543.
Product Usage:
Stationary radiographic System Terminated |
MQB | None listed |
| Sep 27, 2012 | Philips Healthcare Inc. Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3)
System codes: 712020, 712022, 712025
This system is used for making X-ray exposures fo Terminated |
MQB | None listed |
| Sep 14, 2012 | Philips Healthcare Inc. Philips DigitalDiagnost Systems with M Cabinet
Model: 712025
Stationary radiographic system, digital-Universal RAD Applications Terminated |
MQB | None listed |
| Jun 15, 2012 | Philips Healthcare Inc. Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon
Stationary Fluoroscopic system Terminated |
MQB | None listed |
| Apr 26, 2012 | Philips Healthcare Inc. Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option
Intended use: Stationary radiographic system, Radiographic system, digital Terminated |
MQB | None listed |
| Nov 30, 2011 | Philips Healthcare Inc. Philips Digital Diagnost Rel 3, a radiographic system, digital
Intended use: Radiographic system, digital Terminated |
MQB | None listed |
| Oct 7, 2010 | Philips Medical Systems North America Co. Phillips The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during th Terminated |
KPR | None listed |
| Sep 14, 2010 | Philips Medical Systems North America Co. Phillips DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 Terminated |
KPR | None listed |
| Mar 23, 2010 | Philips Medical Systems North America Co. Phillips DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used. Terminated |
MQB | None listed |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Digital Diagnost X-Ray system Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.