510(k) K152977 ยท LLZ System, Image Processing, Radiological
DG PACS
| Applicant | Dicom Grid, Inc., Phoenix AZ, US |
| Decision | Substantially Equivalent, Jan 25, 2016 |
| Received | Oct 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152977
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2017 | DICOM GRID INC Ambra PACS
UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R
Software Version Number: V3.16.13.0
Intended for use as a primary diagnostic and analysis tool for diagnostic images. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.