510(k) K153059
K153059 is an FDA 510(k) premarket notification submitted by Minxray, Inc. for the device "HF1202H PowerPlus Portable X-ray Equipment". The FDA issued a decision of Substantially Equivalent on Feb 2, 2016. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Minxray, Inc. has 17 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 2, 2016
- Date Received
- Oct 21, 2015
- 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)