Clearance Summary
OMEGA 500 RECTANGULAR FIELD CAMERA W/SC received FDA 510(k) clearance under submission number K813073, sponsored by Technicare 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 1981-12-08.
- Submission: K813073
- Applicant / Sponsor: Technicare Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1981-12-08
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.