510(k) K182153 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Ultrasound System SONIMAGE HS1
| Applicant | Konica Minolta, Inc., Hino-Shi, JP |
| Decision | Substantially Equivalent, Sep 6, 2018 |
| Received | Aug 8, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182153
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.