Clearance Summary
PROTURA COUCH SOFTWARE received FDA 510(k) clearance under submission number K132084, sponsored by Med-Tec, Inc. D/B/A Civco Medical Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-09-26.
- Submission: K132084
- Applicant / Sponsor: Med-Tec, Inc. D/B/A Civco Medical Solutions
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5770
- Decision date: 2013-09-26
Classification & Regulation
This clearance is catalogued under FDA product code JAI and 21 CFR 892.5770, within the Radiology review panel as a Class II device.