Clearance Summary
X-RAY COLLIMATOR received FDA 510(k) clearance under submission number K781675, sponsored by General X-Ray, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1978-12-04.
- Submission: K781675
- Applicant / Sponsor: General X-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.1840
- Decision date: 1978-12-04
Classification & Regulation
This clearance is catalogued under FDA product code EHB and 21 CFR 872.1840, within the Dental review panel as a Class I device.