Clearance Summary
PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 received FDA 510(k) clearance under submission number K090655, sponsored by Source-Ray, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-07-14.
- Submission: K090655
- Applicant / Sponsor: Source-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 2009-07-14
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.