510(k) K212005 ยท LLZ System, Image Processing, Radiological
UNiD Spine Analyzer
| Applicant | Medicrea International, Inc., Rilleux La Pape, FR |
| Decision | Substantially Equivalent, Jan 12, 2022 |
| Received | Jun 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2025 | Medicrea International UNiD" Adaptive Spine Intelligence
UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929
Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD H Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.