Clearance Summary
DIAL X COLLIMATOR MODEL A&B received FDA 510(k) clearance under submission number K771689, sponsored by Bennett X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1977-09-14.
- Submission: K771689
- Applicant / Sponsor: Bennett X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1977-09-14
Classification & Regulation
This clearance is catalogued under FDA product code IZX and 21 CFR 892.1610, within the Radiology review panel as a Class II device.