510(k) K152165 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
S9 Portable Digital Color Doppler Ultrasound System
| Applicant | Sonoscape Medical Corp., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 26, 2015 |
| Received | Aug 3, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152165
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2014 | Philips Ultrasound, Inc. QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. Terminated |
LLZ | None listed |
| Jul 23, 2014 | Philips Ultrasound, Inc. QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.