Cleared Traditional

LINAC SCALPEL FLOORSTAND

K964517 · Surgical Navigation Technologies, Inc. · Radiology
Apr 1997
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K964517 is an FDA 510(k) clearance for the LINAC SCALPEL FLOORSTAND, 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 April 1, 1997, 140 days after receiving the submission on November 12, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K964517 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1996
Decision Date April 01, 1997
Days to Decision 140 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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