510(k) DEN170022 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QuantX
| Applicant | Quantitative Insights, Inc., Chicago IL, US |
| Decision | Unknown, Jul 19, 2017 |
| Received | Apr 7, 2017 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN170022
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.