Clearance Summary
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 received FDA 510(k) clearance under submission number K993598, sponsored by Vidar Systems 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 2000-01-20.
- Submission: K993598
- Applicant / Sponsor: Vidar Systems Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2030
- Decision date: 2000-01-20
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.