Clearance Summary
THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL received FDA 510(k) clearance under submission number K895442, sponsored by Altek 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 1989-12-14.
- Submission: K895442
- Applicant / Sponsor: Altek Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5840
- Decision date: 1989-12-14
Classification & Regulation
This clearance is catalogued under FDA product code KPQ and 21 CFR 892.5840, within the Radiology review panel as a Class II device.