510(k) K011604 ยท LNI System, Nuclear Magnetic Resonance Spectroscopic
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
| Applicant | Ge Medical Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 22, 2001 |
| Received | May 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011604
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.