510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013531Substantially Equivalent

Qwiksim Virtual Simulation System; Version 2.00

Elekta Limited, Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013531 is the FDA 510(k) clearance record for QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00, a class II device, cleared for Impac Medical Systems, Inc. on under FDA product code KPQ (System, Simulation, Radiation Therapy). FDA records list 58 510(k) clearances for ELEKTA LIMITED, from to . As of , FDA records show no recalls naming K013531.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KPQ System, Simulation, Radiation Therapy
Regulation
21 CFR 892.5840
Device class
Class II
Review panel
Radiology
Applicant
Impac Medical Systems, Inc. 100 W. Evelyn Ave., Mountain View CA
510(k) summary
Summary
Third party review
Yes

Clearances, product code KPQ

Trailing 12 months

FDA records hold no clearances under product code KPQ in the trailing twelve months.

FDA records show no clearances under product code KPQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260