510(k) K013858 ยท LNH System, Nuclear Magnetic Resonance Imaging
INFINION 0.6T MR IMAGING SYSTEM
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jan 22, 2002 |
| Received | Nov 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013858
| 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 Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143 Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.