QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00— 510(k) K013531

Name: FDA 510(k) clearance K013531
Creator: U.S. Food and Drug Administration
Published: 2001-11-07

Substantially Equivalent

Impac Medical Systems, Inc.

FDA 510(k) clearance K013531 for QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00, Substantially Equivalent on 2001-11-07. Applicant: Impac Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Impac Medical Systems, Inc.
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 2001-10-23
Decision date: 2001-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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