Cleared Traditional

K100056 - MEDCOM RT-VIEWER SYSTEM

K100056 is an FDA 510(k) clearance for MEDCOM RT-VIEWER SYSTEM, manufactured by Medcom GmbH. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K100056 · Medcom GmbH · Radiology device
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May 2010
Decision
119d
Days
Class 2
Risk

K100056 is an FDA 510(k) clearance for the MEDCOM RT-VIEWER SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Medcom GmbH (Darmstadt, Hessen, DE). The FDA issued a Cleared decision on May 7, 2010 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 - K100056

510(k) Number K100056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2010
Decision Date May 07, 2010
Days to Decision 119 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - MUJ System, Planning, Radiation Therapy Treatment

All 213
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K100056.
XIO RTP SYSTEM
K102216 · Computerized Medical Systems, Inc. · Oct 2010
ECLIPSE TREATMENT PLANNING SYSTEM
K102011 · Varian Medical Systems, Inc. · Sep 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
K101119 · Siemens Medical Solutions USA, Inc. · Jun 2010
XIO RTP SYSTEM
K092132 · Computerized Medical Systems, Inc. · Sep 2009
LEKSELL GAMMAPLAN
K090972 · Elekta Instrument AB · Jul 2009
MONACO RTP SYSTEM, VMAT OPTION
K091179 · Computerized Medical Systems, Inc. · Jul 2009