Clearance Summary
EMISONIC 4500 TM received FDA 510(k) clearance under submission number K771930, sponsored by Emi Medical, 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 1977-10-27.
- Submission: K771930
- Applicant / Sponsor: Emi Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1977-10-27
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.