Clearance Summary
CTF MODEL 9300 received FDA 510(k) clearance under submission number K813588, sponsored by Thomson-Csf Broadcast, 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 1982-02-04.
- Submission: K813588
- Applicant / Sponsor: Thomson-Csf Broadcast, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 1982-02-04
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.