510(k) K964124 ยท LLZ System, Image Processing, Radiological
PHILIPS COMPUTED RADIOGRAPHY
| Applicant | Philips Medical Systems, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Dec 18, 1996 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2016 | Philips Electronics North America Corporation PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040.
Radiological image processing system (Computed Radiography). Terminated |
LLZ | None listed |
| Sep 14, 2011 | Philips Healthcare Inc. PCR Eleva Radiological Image Processing System with software R.1.2
Philips Healthcare, Inc.
A computed radiography image processing system. Terminated |
LLZ | None listed |
| Feb 4, 2011 | Philips Medical Systems North America Co. Phillips PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V".
Provides on Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.