510(k) K011296 ยท LNH System, Nuclear Magnetic Resonance Imaging
INFINION ENHANCEMENT PACKAGE
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jul 19, 2001 |
| Received | Apr 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, 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 Infinion is Nuclear Magnetic Resonance Imaging. Philips Infinion 1.5T System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.. Terminated |
LNH | None listed |
| Dec 2, 2004 | Philips Medical Systems (Cleveland) Inc Intinion 1.5 T MRI Scanner. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.