Cleared Traditional

K042041 - XPLORER 1600

K042041 is an FDA 510(k) clearance for XPLORER 1600, manufactured by Imaging Dynamics Company Limited. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K042041 · Imaging Dynamics Company Limited · Radiology device
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Sep 2004
Decision
50d
Days
Class 2
Risk

K042041 is an FDA 510(k) clearance for the XPLORER 1600. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Imaging Dynamics Company Limited (Calgary, CA). The FDA issued a Cleared decision on September 17, 2004 after a review of 50 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 Imaging Dynamics Company Limited devices

FDA 510(k) Submission Details - K042041

510(k) Number K042041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2004
Decision Date September 17, 2004
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
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 336
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