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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - KPR System, X-ray, Stationary

All 320
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K133496.
PODIATRY X-RAY SYSTEM
K133959 · Source-Ray, Inc. · Jan 2015
EOS System
K142773 · Eos Imaging · Jan 2015
MULTIX FUSION VA30 & VA40
K142049 · Siemens Medical Solutions USA, Inc. · Dec 2014
TITAN 11
K133695 · Gemss Medical Systems Co., Ltd. · Aug 2014
DURADIAGNOST
K141381 · Philips Healthcare (Suzhou) Co., Ltd. · Jun 2014
0180 INTUITION, 0072 PRECISION
K140683 · Arcoma AB · Jun 2014