Clearance Summary
S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM received FDA 510(k) clearance under submission number K132768, sponsored by Sonoscape Company Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-10-04.
- Submission: K132768
- Applicant / Sponsor: Sonoscape Company Limited
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2013-10-04
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.