K213620 is an FDA 510(k) clearance for the ATUSA™ Automated 3D Breast Ultrasound System. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Isono Health, Inc. (South San Francisco, US). The FDA issued a Cleared decision on April 22, 2022, 157 days after receiving the submission on November 16, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K213620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2021 |
| Decision Date | April 22, 2022 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |