510(k) K934889 ยท LMB Device, Digital Image Storage, Radiological
OLYMPUS IMAGEMANAGER SYSTEM
| Applicant | Olympus, Lake Success NY, US |
| Decision | Substantially Equivalent, Jan 28, 1994 |
| Received | Oct 13, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2003 | Olympus America Inc. Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8)
Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software Terminated |
LMB | None listed |
| Aug 12, 2003 | Olympus America Inc. Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt. Terminated |
LMB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.