Clearance Summary
DYNAMIC WEDGE received FDA 510(k) clearance under submission number K970564, sponsored by Mitsubishi Electronics America, 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 1997-05-12.
- Submission: K970564
- Applicant / Sponsor: Mitsubishi Electronics America, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1997-05-12
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.