Clearance Summary
FULL VIEW OMEGA TABLE received FDA 510(k) clearance under submission number K905827, sponsored by Med-Tron Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-01-28.
- Submission: K905827
- Applicant / Sponsor: Med-Tron Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1991-01-28
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.