Clearance Summary
FILM DIGITZER, MODEL 2908 MAMMO PRO received FDA 510(k) clearance under submission number K063424, sponsored by Array Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-12-21.
- Submission: K063424
- Applicant / Sponsor: Array Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2030
- Decision date: 2006-12-21
Classification & Regulation
This clearance is catalogued under FDA product code LMA and 21 CFR 892.2030, within the Radiology review panel as a Class II device.