Clearance Summary
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) received FDA 510(k) clearance under submission number K161459, sponsored by Varian Medical Systems, X-Ray Products-Infimed. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-09-06.
- Submission: K161459
- Applicant / Sponsor: Varian Medical Systems, X-Ray Products-Infimed
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2016-09-06
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.