510(k) K150122 ยท LLZ System, Image Processing, Radiological
TOMTEC-ARENA TTA2
| Applicant | Tomtec Imaging Systems GmbH, Unterschleissheim, DE |
| Decision | Substantially Equivalent, Feb 13, 2015 |
| Received | Jan 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150122
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2019 | Tomtec Imaging Systems Gmbh TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system.
Software Versions and applicable UDI:
TTA 1.2
release prior to UDI requirement
TTA2.00.01
release Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.