K183191 is an FDA 510(k) clearance for the 6420 Ultrasound System. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Esaote, S.P.A. (Genoa, IT). The FDA issued a Cleared decision on December 4, 2018, 15 days after receiving the submission on November 19, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K183191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2018 |
| Decision Date | December 04, 2018 |
| Days to Decision | 15 days |
| Submission Type | Special |
| 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 |