Clearance Summary
US ALOKA SSD-256 ULTRASONIC SCANNER received FDA 510(k) clearance under submission number K813177, sponsored by U. S. A. Imaging Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1982-03-05.
- Submission: K813177
- Applicant / Sponsor: U. S. A. Imaging Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1982-03-05
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.