510(k) K140723

NOMAD MD 75K V HANDHELD X-RAY SYSTEM by Aribex, Inc. — Product Code IZL

K140723 is an FDA 510(k) premarket notification submitted by Aribex, Inc. for the device "NOMAD MD 75K V HANDHELD X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 19, 2014. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Aribex, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2014
Date Received
March 21, 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