Clearance Summary
DR 800 with Tomosynthesis received FDA 510(k) clearance under submission number K183275, sponsored by Agfa N.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-02-01.
- Submission: K183275
- Applicant / Sponsor: Agfa N.V.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1740
- Decision date: 2019-02-01
Classification & Regulation
This clearance is catalogued under FDA product code IZF and 21 CFR 892.1740, within the Radiology review panel as a Class II device.