Cleared Traditional

FUSIONSYNC, CHIMAERA FUSIONSYNC (K132963) - FDA 510(k) Clearance

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

K132963 · Chimaera GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
87d
Days
Class 2
Risk

K132963 is an FDA 510(k) clearance for the FUSIONSYNC, CHIMAERA FUSIONSYNC. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Chimaera GmbH (Erlangen, Bavaria, DE). The FDA issued a Cleared decision on December 16, 2013 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Chimaera GmbH devices

Submission Details

510(k) Number K132963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2013
Decision Date December 16, 2013
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 730
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K132963.
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
K133401 · Siemens Medical Solutions USA, Inc. · Mar 2014
SCENIUM
K133654 · Siemens Medical Solutions USA, Inc. · Feb 2014
SYNGO.VIA MI WORKFLOWS
K133644 · Siemens Medical Solutions USA, Inc. · Feb 2014
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
K132636 · Smith & Nephew, Inc. · Oct 2013
SYNGO.MR GENERAL
K130749 · Siemens Medical Solutions USA, Inc. · Aug 2013
ESIE APPS SUITE
K132062 · Siemens Medical Solutions USA, Inc. · Jul 2013