Cleared Traditional

VSS, VIRTUAL SIMULATION SYSTEM

K980629 · Nucletron Corp. · Radiology
May 1998
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K980629 is an FDA 510(k) clearance for the VSS, VIRTUAL SIMULATION SYSTEM, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on May 6, 1998, 77 days after receiving the submission on February 18, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K980629 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1998
Decision Date May 06, 1998
Days to Decision 77 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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