Clearance Summary
1.5T MRGFUS PELVIC COIL received FDA 510(k) clearance under submission number K071966, sponsored by Insightec-Txsonics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2007-09-05.
- Submission: K071966
- Applicant / Sponsor: Insightec-Txsonics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2007-09-05
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.