510(k) K123650

ARIX RAD ACQUISITION CONSOLE by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. — Product Code LLZ

K123650 is an FDA 510(k) premarket notification submitted by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. for the device "ARIX RAD ACQUISITION CONSOLE". The FDA issued a decision of Substantially Equivalent on Feb 20, 2013. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. has 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 20, 2013
Date Received
Nov 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type
510(k)