Cleared Traditional

SMART SPOT

K961307 · Cmt Medical Technologies, Ltd. · Radiology
Jul 1996
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K961307 is an FDA 510(k) clearance for the SMART SPOT, 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 July 1, 1996, 88 days after receiving the submission on April 4, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K961307 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1996
Decision Date July 01, 1996
Days to Decision 88 days
Submission Type Traditional
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