Clearance Summary
MEDX ROTATIONAL GANTRY SYSTEM received FDA 510(k) clearance under submission number K923356, sponsored by Bfi- Medical Waste Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-09-21.
- Submission: K923356
- Applicant / Sponsor: Bfi- Medical Waste Systems
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1992-09-21
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.