510(k) K182213 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
QT Ultrasound Breast Scanner - 1
| Applicant | Qt Ultrasound, LLC, Novato CA, US |
| Decision | Substantially Equivalent, Sep 14, 2018 |
| Received | Aug 15, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182213
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.