Cleared Traditional

K080742 - VERISUITE 1.6, VERISUITE-PARTICLE 1.6 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080742 · Medcom GmbH · Radiology device
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Optimized for regulatory review, auditing and printing
May 2008
Decision
53d
Days
Class 2
Risk

K080742 is an FDA 510(k) clearance for the VERISUITE 1.6, VERISUITE-PARTICLE 1.6. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medcom GmbH (Darmstadt, Hessen, DE). The FDA issued a Cleared decision on May 9, 2008 after a review of 53 days - a notably fast clearance cycle.

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: 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 Medcom GmbH devices

Submission Details

510(k) Number K080742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2008
Decision Date May 09, 2008
Days to Decision 53 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
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
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 - IYE Accelerator, Linear, Medical

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