Cleared Traditional

IMMERGE IMAGE CORRELATION

K970623 · Surgical Navigation Technologies, Inc. · Radiology
Apr 1997
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K970623 is an FDA 510(k) clearance for the IMMERGE IMAGE CORRELATION, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Surgical Navigation Technologies, Inc. (Broomfield, US). The FDA issued a Cleared decision on April 28, 1997, 68 days after receiving the submission on February 19, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K970623 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1997
Decision Date April 28, 1997
Days to Decision 68 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