Cleared Traditional

K050718 - DDRCOMBI TRAUMA

K050718 is an FDA 510(k) clearance for DDRCOMBI TRAUMA, manufactured by Swissray International, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K050718 · Swissray International, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
66d
Days
Class 2
Risk

K050718 is an FDA 510(k) clearance for the DDRCOMBI TRAUMA. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Swissray International, Inc. (Elizabeth, US). The FDA issued a Cleared decision on May 26, 2005 after a review of 66 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 International, Inc. devices

FDA 510(k) Submission Details - K050718

510(k) Number K050718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date May 26, 2005
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 296
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K050718.
DIRECT DIGITIZER REGIUS MODEL 370
K051418 · Konica Minolta Medical & Graphic, Inc. · Jul 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · Eastman Kodak Company · Jun 2005
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
K050925 · Shimadzu Corp. · Jun 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
K050987 · Canon, Inc. · Apr 2005
AGFA CR50.0
K050810 · Agfa Corp. · Apr 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
K042602 · Ge Medical Systems, LLC · Jan 2005