510(k) K945278 ยท KPR System, X-Ray, Stationary
PHILIPS BUCKY DIAGNOST FAMILY
| Applicant | Philips Medical Systems North America, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Dec 14, 1994 |
| Received | Oct 28, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2020 | Philips North America, LLC Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography. Terminated |
KPR | None listed |
| Jul 22, 2015 | Philips Electronics North America Corporation Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis. Terminated |
KPR | None listed |
| Aug 19, 2014 | Philips Medical Systems, Inc. Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037 Terminated |
KPR | None listed |
| Jun 17, 2013 | Philips Healthcare Inc. Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system.
Catalog Numbers:
704031, 704032, 704035, 704060, 704062
This system is used for making x-ray exposures for diagnostics. Terminated |
KPR | None listed |
| Jun 17, 2013 | Philips Healthcare Inc. Philips BuckyDiagnost Radiographic.
Catalog Numbers:
704031, 704032, 704035, 704060, 704062
This system is used for making x-ray exposures for diagnostics Terminated |
KPR | None listed |
| Oct 7, 2010 | Philips Medical Systems North America Co. Phillips The BABIX holder is an accessory used with the BuckyDiagnost 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 the e Terminated |
KPR | None listed |
| Mar 23, 2010 | Philips Medical Systems North America Co. Phillips BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions. Terminated |
KPR | None listed |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Bucky DIagnost X-Ray System Terminated |
KPR | None listed |
| Nov 8, 2005 | Philips Ultrasound, Inc. Optimus 30 Terminated |
KPR | None listed |
| Dec 24, 2003 | Philips Medical Systems Sales & Service Region No. America Bucky Diagnost FS Part number 9890-010-83651 Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.