Clearance Summary
DIAL-A-RAD PORTA RAD TABLE received FDA 510(k) clearance under submission number K913425, sponsored by Dial-A-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-11-24.
- Submission: K913425
- Applicant / Sponsor: Dial-A-Rad
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1992-11-24
Classification & Regulation
This clearance is catalogued under FDA product code IXQ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.