Clearance Summary
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE received FDA 510(k) clearance under submission number K110147, sponsored by Sti Medical Systems, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2011-04-08.
- Submission: K110147
- Applicant / Sponsor: Sti Medical Systems, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1630
- Decision date: 2011-04-08
Classification & Regulation
This clearance is catalogued under FDA product code HEX and 21 CFR 884.1630, within the Obstetrics/Gynecology review panel as a Class II device.