510(k) K060566
K060566 is an FDA 510(k) premarket notification submitted by Mikasa X-Ray Co., Ltd. for the device "MINXRAY, MODELS HFP24 AND HFP40". The FDA issued a decision of Substantially Equivalent on Apr 5, 2006. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 5, 2006
- Date Received
- Mar 3, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)