Cleared Special

K061595 - XAMINER

K061595 is an FDA 510(k) clearance for XAMINER, manufactured by Imaging Dynamics Company , Ltd.. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 70-day FDA review.

K061595 · Imaging Dynamics Company , Ltd. · Radiology device
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Aug 2006
Decision
70d
Days
Class 2
Risk

K061595 is an FDA 510(k) clearance for the XAMINER. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Imaging Dynamics Company , Ltd. (Calgary, Alberta, CA). The FDA issued a Cleared decision on August 17, 2006 after a review of 70 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Imaging Dynamics Company , Ltd. devices

FDA 510(k) Submission Details - K061595

510(k) Number K061595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date August 17, 2006
Days to Decision 70 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
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 - KPR System, X-ray, Stationary

All 264
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