Clearance Summary
OPTION PHO/SONIC B-MODE SCANNER received FDA 510(k) clearance under submission number K781344, sponsored by G.D. Searle and Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1978-08-21.
- Submission: K781344
- Applicant / Sponsor: G.D. Searle and Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1978-08-21
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.