Clearance Summary
MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH received FDA 510(k) clearance under submission number K864042, sponsored by Absolute 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 1986-10-27.
- Submission: K864042
- Applicant / Sponsor: Absolute X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1760
- Decision date: 1986-10-27
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.