Clearance Summary
COMMVIEW SYSTEM received FDA 510(k) clearance under submission number K862715, sponsored by A T & T Technologies, 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 1986-10-16.
- Submission: K862715
- Applicant / Sponsor: A T & T Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1986-10-16
Classification & Regulation
This clearance is catalogued under FDA product code LMD and 21 CFR 892.2020, within the Radiology review panel as a Class I device.