510(k) K964626 ยท LNH System, Nuclear Magnetic Resonance Imaging
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
| Applicant | Philips Medical Systems (Cleveland), Inc., Highland Heights OH, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Nov 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2013 | Philips Medical Systems (Cleveland) Inc Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T
1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applicati Terminated |
LNH | None listed |
| 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 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Eclipse, 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.