510(k) K152467 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Touch Ultrasound
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 9, 2015 |
| Received | Aug 31, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K152467
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2017 | Carestream Health Inc Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System
Diagnostic ultrasound imaging or fluid flow analysis of the human body Terminated |
IYN | None listed |
| Jul 18, 2016 | Carestream Health Inc Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound
Diagnostic ultrasound imaging or fluid flow analysis of the hu Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.