Cleared Traditional

XIRALITE FLOURESCENCE IMAGING SYSTEM X4 (K130003) - FDA 510(k) Clearance

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

K130003 · Mivenion GmbH · Radiology device
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Jan 2014
Decision
394d
Days
Class 2
Risk

K130003 is an FDA 510(k) clearance for the XIRALITE FLOURESCENCE IMAGING SYSTEM X4. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Mivenion GmbH (Berlin, DE). The FDA issued a Cleared decision on January 31, 2014 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Mivenion GmbH devices

Submission Details

510(k) Number K130003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2013
Decision Date January 31, 2014
Days to Decision 394 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
287d slower than avg
Panel avg: 107d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 36
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K130003.
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