Clearance Summary
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels received FDA 510(k) clearance under submission number K180976, sponsored by Pixxgen Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-05-24.
- Submission: K180976
- Applicant / Sponsor: Pixxgen Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2018-05-24
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.