510(k) K003853 ยท LNH System, Nuclear Magnetic Resonance Imaging
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 13, 2001 |
| Received | Dec 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003853
| 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 |
| Feb 29, 2012 | Philips Medical Systems Nederlands Philips Intellispace Portal, Release 4.0.0.
For storing, processing and management of electronic information/data
Model: 881001.
Indicated for use as a diagnostic device. Terminated |
LNH | None listed |
| 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 |
| Feb 19, 2010 | Philips Medical Systems (Cleveland) Inc MRI Eclipse 1.5T System Model #781230.
The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications. 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.