510(k) K143494
K143494 is an FDA 510(k) premarket notification submitted by Dexcowin Co., Ltd. for the device "ADX6000 Portable X-Ray System; iRayA6". The FDA issued a decision of Substantially Equivalent on Oct 5, 2015. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Dexcowin Co., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 2015
- Date Received
- Dec 9, 2014
- Clearance Type
- Traditional
- 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)