510(k) K931544 ยท LNH System, Nuclear Magnetic Resonance Imaging
1.5T EDGE AND 1.0T VISTA SYSTEMS
| Applicant | Philips Medical Systems (Cleveland), Inc., Highland Heights OH, US |
| Decision | Substantially Equivalent, Nov 22, 1993 |
| Received | Mar 29, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.". Terminated |
LNH | None listed |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Vista Nuclear Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.