Cleared Traditional

SNT LINAC ACCESSORIES

K971893 · Surgical Navigation Technologies, Inc. · Radiology
Nov 1997
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K971893 is an FDA 510(k) clearance for the SNT LINAC ACCESSORIES, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Surgical Navigation Technologies, Inc. (Broomfield, US). The FDA issued a Cleared decision on November 13, 1997, 175 days after receiving the submission on May 22, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K971893 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1997
Decision Date November 13, 1997
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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