510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K982857Substantially Equivalent

Helax-Imcon, Version 1.0

Helax AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982857 is the FDA 510(k) clearance record for HELAX-IMCON, VERSION 1.0, a class II device, cleared for Helax AB on under FDA product code KPQ (System, Simulation, Radiation Therapy). FDA records list 2 510(k) clearances for Helax AB, from to . As of , FDA records show no recalls naming K982857.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KPQ System, Simulation, Radiation Therapy
Regulation
21 CFR 892.5840
Device class
Class II
Review panel
Radiology
Applicant
Helax AB Klostergatan 10-12, Uppsala, SE
510(k) summary
Summary
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