Clearance Summary
AT3C70 TRANSDUCER received FDA 510(k) clearance under submission number K002856, sponsored by Sonora Medical Systems. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-04-02.
- Submission: K002856
- Applicant / Sponsor: Sonora Medical Systems
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2001-04-02
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.