Cleared Traditional

K122768 - GENESIS

K122768 is an FDA 510(k) clearance for GENESIS, manufactured by Dornier Medtech America, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K122768 · Dornier Medtech America, Inc. · Radiology device
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Jan 2013
Decision
130d
Days
Class 2
Risk

K122768 is an FDA 510(k) clearance for the GENESIS. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Dornier Medtech America, Inc. (Washington, US). The FDA issued a Cleared decision on January 18, 2013 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Dornier Medtech America, Inc. devices

FDA 510(k) Submission Details - K122768

510(k) Number K122768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2012
Decision Date January 18, 2013
Days to Decision 130 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 107d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

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