Cleared Traditional

K022219 - EXOMIO

K022219 is the FDA 510(k) clearance for EXOMIO by Medcom GmbH. It is a Class 2 Radiology device (product code KPQ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K022219 · Medcom GmbH · Radiology device
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Oct 2002
Decision
90d
Days
Class 2
Risk

K022219 is an FDA 510(k) clearance for the EXOMIO, MODEL 1.1. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Medcom GmbH (Darmstadt, Hessen, DE). The FDA issued a Cleared decision on October 7, 2002 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcom GmbH devices

Submission Details

510(k) Number K022219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2002
Decision Date October 07, 2002
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K022219.
ADVANTAGE SIM MD
K052345 · Ge Healthcare · Sep 2005
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
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · Varian Medical Systems, Inc. · Aug 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · Varian Medical Systems, Inc. · Jan 1997