Cleared Traditional

K982857 - HELAX-IMCON, VERSION 1.0

K982857 is an FDA 510(k) clearance for HELAX-IMCON, manufactured by Helax AB. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K982857 · Helax AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
83d
Days
Class 2
Risk

K982857 is an FDA 510(k) clearance for the HELAX-IMCON, VERSION 1.0. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Helax AB (Uppsala, SE). The FDA issued a Cleared decision on November 4, 1998 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Helax AB devices

FDA 510(k) Submission Details - K982857

510(k) Number K982857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1998
Decision Date November 04, 1998
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPQ Device Classification - Class 2, Special Controls

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPQ System, Simulation, Radiation Therapy

All 36
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K982857.
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
K033339 · Varian Medical Systems, Inc. · Dec 2003
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002
SOMAVISION
K992751 · Varian Assoc., Inc. · Feb 2000
IBU, INTEGRATED BRACHY THERAPY UNIT
K973848 · Nucletron Corp. · Jan 1998
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · Varian Medical Systems, Inc. · Aug 1997
SHADOWFORM
K964972 · I.Z.I. Medical Products Corp. · May 1997