Cleared Special

K071402 - X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM

K071402 is an FDA 510(k) clearance for X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM, 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 18-day FDA review.

K071402 · Imaging Dynamics Company , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
18d
Days
Class 2
Risk

K071402 is an FDA 510(k) clearance for the X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Imaging Dynamics Company , Ltd. (Calgary, CA). The FDA issued a Cleared decision on June 8, 2007 after a review of 18 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 - K071402

510(k) Number K071402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date June 08, 2007
Days to Decision 18 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
89d faster than avg
Panel avg: 107d · This submission: 18d
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
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K071402.
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X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
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