Clearance Summary
SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER received FDA 510(k) clearance under submission number K092922, sponsored by Sonoscape Company Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-03-12.
- Submission: K092922
- Applicant / Sponsor: Sonoscape Company Limited
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2010-03-12
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.