Cleared Traditional

K022219 - EXOMIO, MODEL 1.1

K022219 is an FDA 510(k) clearance for EXOMIO, manufactured by Medcom GmbH. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K022219

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.

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 41
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K022219.
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K023052 · Varian Medical Systems, Inc. · Oct 2002
SOMAVISION
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IBU, INTEGRATED BRACHY THERAPY UNIT
K973848 · Nucletron Corp. · Jan 1998