Clearance Summary
MWX-7440 HIGH SPEED BUCKY received FDA 510(k) clearance under submission number K924423, sponsored by Midwest X-Ray Equipment Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-01-15.
- Submission: K924423
- Applicant / Sponsor: Midwest X-Ray Equipment Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1860
- Decision date: 1993-01-15
Classification & Regulation
This clearance is catalogued under FDA product code KPX and 21 CFR 892.1860, within the Radiology review panel as a Class II device.