510(k) K041947 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
| Applicant | Innovative Imaging, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Aug 16, 2004 |
| Received | Jul 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041947
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2007 | Ellex Inc. Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Ellex Innovative Imaging, Sacramento, CA 95827 Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.