Clearance Summary
GAMMACON IMAGE TRANSLATION SYSTEM received FDA 510(k) clearance under submission number K962955, sponsored by Medical Imaging Technology Assoc., 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 1996-10-28.
- Submission: K962955
- Applicant / Sponsor: Medical Imaging Technology Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 1996-10-28
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.