Clearance Summary
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE received FDA 510(k) clearance under submission number K970652, sponsored by Mitra Imaging, 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 1997-05-02.
- Submission: K970652
- Applicant / Sponsor: Mitra Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1997-05-02
Classification & Regulation
This clearance is catalogued under FDA product code LMD and 21 CFR 892.2020, within the Radiology review panel as a Class I device.