Cleared Traditional

RADIOCAMERAS PATIENT POSITIONING SYSTEM

K980750 · Surgical Navigation Technologies, Inc. · Radiology
May 1998
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K980750 is an FDA 510(k) clearance for the RADIOCAMERAS PATIENT 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 May 20, 1998, 83 days after receiving the submission on February 26, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K980750 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1998
Decision Date May 20, 1998
Days to Decision 83 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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