Cleared Traditional

K133496 - X TWIN SYSTEM

K133496 is an FDA 510(k) clearance for X TWIN SYSTEM, manufactured by Roesys GmbH. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K133496 · Roesys GmbH · Radiology device
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Dec 2014
Decision
384d
Days
Class 2
Risk

K133496 is an FDA 510(k) clearance for the X TWIN SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Roesys GmbH (Espelkamp, Nordrhein-Westfalen, DE). The FDA issued a Cleared decision on December 3, 2014 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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. Elevated predicate reliance profile. 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 Roesys GmbH devices

FDA 510(k) Submission Details - K133496

510(k) Number K133496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2013
Decision Date December 03, 2014
Days to Decision 384 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
277d slower than avg
Panel avg: 107d · This submission: 384d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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.

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All 206
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