Clearance Summary
ATUSA Automated 3D Breast Ultrasound System received FDA 510(k) clearance under submission number K213620, sponsored by Isono Health, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-04-22.
- Submission: K213620
- Applicant / Sponsor: Isono Health, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2022-04-22
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.