510(k) K031552 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
| Applicant | Medison America, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, May 30, 2003 |
| Received | May 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2008 | Philips Medical Systems Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021.
Pulse Doppler Imaging Sys Terminated |
IYN | None listed |
| Dec 31, 2008 | Philips Medical Systems Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Product also mark Terminated |
IYN | None listed |
| Sep 16, 2008 | Philips Medical Systems Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body. Terminated |
IYN | None listed |
| Sep 16, 2008 | Philips Medical Systems Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body. Terminated |
IYN | None listed |
| Sep 16, 2008 | Philips Medical Systems Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.