Clearance Summary
MAMMI received FDA 510(k) clearance under submission number K140996, sponsored by General Equipment For Medical Imaging (Oncovision-. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-06-11.
- Submission: K140996
- Applicant / Sponsor: General Equipment For Medical Imaging (Oncovision-
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2014-06-11
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.