510(k) K051523 ยท LLZ System, Image Processing, Radiological
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION
| Applicant | Konica Minolta Medical & Graphic, Inc., Watarai-Gun, Mie-Ken, JP |
| Decision | Substantially Equivalent, Jul 20, 2005 |
| Received | Jun 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051523
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2006 | Konica Minolta Medical Imaging USA, Inc. REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technol Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.