Clearance Summary
QUIX DIGITAL RADIOGRAPHIC UPGRADE received FDA 510(k) clearance under submission number K052661, sponsored by Edge Medical Devices , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-06-07.
- Submission: K052661
- Applicant / Sponsor: Edge Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2006-06-07
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.