Cleared Traditional

K131314 - DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)

K131314 is an FDA 510(k) clearance for DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-R..., manufactured by Swissray Medical AG. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K131314 · Swissray Medical AG · Radiology device
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Jun 2013
Decision
49d
Days
Class 2
Risk

K131314 is an FDA 510(k) clearance for the DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM). Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Swissray Medical AG (Hochdorf, CH). The FDA issued a Cleared decision on June 25, 2013 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Swissray Medical AG devices

FDA 510(k) Submission Details - K131314

510(k) Number K131314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2013
Decision Date June 25, 2013
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 294
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