510(k) K202414 ยท LLZ System, Image Processing, Radiological
BrainInsight
| Applicant | Hyperfine Research, Inc., Guildford CT, US |
| Decision | Substantially Equivalent, Jan 7, 2021 |
| Received | Aug 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202414
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.