510(k) K013344 ยท LNH System, Nuclear Magnetic Resonance Imaging
INTERA I/T
| Applicant | Philips Medical Systems North America Co., Milford CT, US |
| Decision | Substantially Equivalent, Dec 11, 2001 |
| Received | Oct 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013344
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.