Clearance Summary
ADC COMPACT PLUS received FDA 510(k) clearance under submission number K013138, sponsored by Agfa-Gevaert AG. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-09-28.
- Submission: K013138
- Applicant / Sponsor: Agfa-Gevaert AG
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2001-09-28
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.