Clearance Summary
MINXRAY, MODELS HFP24 AND HFP40 received FDA 510(k) clearance under submission number K060566, sponsored by Mikasa X-Ray Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-04-05.
- Submission: K060566
- Applicant / Sponsor: Mikasa X-Ray Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 2006-04-05
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.