Cleared Special

SMARTSPOT PRIMAX

K080890 · Cmt Medical Technologies, Ltd. · Radiology
Apr 2008
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K080890 is an FDA 510(k) clearance for the SMARTSPOT PRIMAX, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on April 29, 2008, 29 days after receiving the submission on March 31, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K080890 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2008
Decision Date April 29, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050