Cleared Traditional

RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM

K981346 · Surgical Navigation Technologies, Inc. · Radiology
Jul 1998
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K981346 is an FDA 510(k) clearance for the RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM, 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 July 10, 1998, 87 days after receiving the submission on April 14, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K981346 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1998
Decision Date July 10, 1998
Days to Decision 87 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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