Clearance Summary
X-POSURE SYSTEM VERSION 2 MAMMO received FDA 510(k) clearance under submission number K003656, sponsored by Pronosco A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-12-15.
- Submission: K003656
- Applicant / Sponsor: Pronosco A/S
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 2000-12-15
Classification & Regulation
This clearance is catalogued under FDA product code KGI and 21 CFR 892.1170, within the Radiology review panel as a Class II device.