Clearance Summary
MULTIPLE ED1600 SERIES RADIATION SHIELDS received FDA 510(k) clearance under submission number K944772, sponsored by Image Diagnostics, 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 1994-10-20.
- Submission: K944772
- Applicant / Sponsor: Image Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1994-10-20
Classification & Regulation
This clearance is catalogued under FDA product code EAK and 21 CFR 892.6500, within the Radiology review panel as a Class I device.