510(k) K001796 ยท LNH System, Nuclear Magnetic Resonance Imaging
GYROSCAN INTERA (R7.5)
| Applicant | Philips Medical Systems North America, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Sep 6, 2000 |
| Received | Jun 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2016 | Philips Electronics North America Corporation SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system 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 Intera MRI Terminated |
LNH | None listed |
| Sep 29, 2004 | Philips Medical Systems Sales & Service Region No. America NT Intera Magnetic Resonance Image System Terminated |
KRP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.