Clearance Summary
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO received FDA 510(k) clearance under submission number K000159, sponsored by Agfa Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-02-16.
- Submission: K000159
- Applicant / Sponsor: Agfa Corp.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1630
- Decision date: 2000-02-16
Classification & Regulation
This clearance is catalogued under FDA product code IXK and 21 CFR 892.1630, within the Radiology review panel as a Class II device.