510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132045Substantially Equivalent

Advantagesim Md with CT Atlas-Based Contouring and Re-Planning Options

GE Hungary Kft, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132045 is the FDA 510(k) clearance record for ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS, a class II device, cleared for Ge Hungary Kft on under FDA product code KPQ (System, Simulation, Radiation Therapy). FDA records list 2 510(k) clearances for Ge Hungary Kft, from to . As of , FDA records show no recalls naming K132045.

Clearance record

Decision date
Received
(64 days to decision)
Product code
KPQ System, Simulation, Radiation Therapy
Regulation
21 CFR 892.5840
Device class
Class II
Review panel
Radiology
Applicant
Ge Hungary Kft 3000 N Grandview, Waukesha WI
510(k) summary
Summary PDF
Third party review
No

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