510(k) K141885

CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY by Minxray, Inc. — Product Code IZL

K141885 is an FDA 510(k) premarket notification submitted by Minxray, Inc. for the device "CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY". The FDA issued a decision of Substantially Equivalent on Sep 18, 2014. 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
Sep 18, 2014
Date Received
Jul 11, 2014
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)