510(k) K031815 ยท LNH System, Nuclear Magnetic Resonance Imaging
INTERA-SENSATION FAMILY
| Applicant | Philips Medical Systems, Bothell WA, US |
| Decision | Substantially Equivalent, Sep 10, 2003 |
| Received | Jun 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031815
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2010 | Philips Medical Systems North America Co. Phillips Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit.
Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orie Terminated |
LNH | None listed |
| Nov 26, 2010 | Philips Medical Systems North America Co. Phillips The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems".
The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the dr Terminated |
LNH | None listed |
| Jun 27, 2007 | Philips Medical Systems North America Co. Phillips Achieva MRI Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.