Clearance Summary
RIT 113 FILM ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K935928, sponsored by Radiological Imaging Technology, 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 1994-07-29.
- Submission: K935928
- Applicant / Sponsor: Radiological Imaging Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1994-07-29
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.