Cleared Traditional

IMMERGE IMAGE CORRELATION

K991468 · Surgical Navigation Technologies, Inc. · Radiology
Jul 1999
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K991468 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 July 6, 1999, 70 days after receiving the submission on April 27, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K991468 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1999
Decision Date July 06, 1999
Days to Decision 70 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