Clearance Summary
EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. received FDA 510(k) clearance under submission number K760604, sponsored by Eureka X-Ray Tube 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 1976-09-13.
- Submission: K760604
- Applicant / Sponsor: Eureka X-Ray Tube Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1760
- Decision date: 1976-09-13
Classification & Regulation
This clearance is catalogued under FDA product code ITY and 21 CFR 892.1760, within the Radiology review panel as a Class I device.