K050326 is an FDA 510(k) clearance for the 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Esaote, S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on February 28, 2005, 19 days after receiving the submission on February 9, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K050326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2005 |
| Decision Date | February 28, 2005 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |