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

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 423
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