Clearance Summary
IREX PS, PORTABLE SCANNER AND 118 received FDA 510(k) clearance under submission number K844404, sponsored by Irex 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 1985-02-04.
- Submission: K844404
- Applicant / Sponsor: Irex Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1985-02-04
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.