510(k) K043112 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 24, 2004 |
| Received | Nov 10, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2013 | GE Healthcare, LLC GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System.
Indicated for use as a diagnostic imaging device. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.