Clearance Summary
TCA 5R / 5S received FDA 510(k) clearance under submission number K070123, sponsored by Dornier Medtech America, 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 2007-03-09.
- Submission: K070123
- Applicant / Sponsor: Dornier Medtech America, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2007-03-09
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.