Clearance Summary
CLARK TUT IMAGE PROCESSING SYSTEM received FDA 510(k) clearance under submission number K954589, sponsored by Clark Research and Development, 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 1996-01-05.
- Submission: K954589
- Applicant / Sponsor: Clark Research and Development, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1996-01-05
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.