Clearance Summary
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) received FDA 510(k) clearance under submission number K130318, sponsored by Varian Medical Systems, X-Ray Products-Infimed. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-04-22.
- Submission: K130318
- Applicant / Sponsor: Varian Medical Systems, X-Ray Products-Infimed
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2013-04-22
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.