Cleared Special

K071403 - X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM

K071403 is an FDA 510(k) clearance for X3C 1600 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 21-day FDA review.

K071403 · Imaging Dynamics Company , Ltd. · Radiology device
Download Printable Device Report (PDF)
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Jun 2007
Decision
21d
Days
Class 2
Risk

K071403 is an FDA 510(k) clearance for the X3C 1600 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 11, 2007 after a review of 21 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 - K071403

510(k) Number K071403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date June 11, 2007
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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 K071403.
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
K071401 · Imaging Dynamics Company , Ltd. · Jun 2007
SYNERAD OMNI, MODELS AN6255 AND AN6265
K071430 · Analogic Corp. · Jun 2007
X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR
K071408 · Imaging Dynamics Company , Ltd. · Jun 2007
X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
K071402 · Imaging Dynamics Company , Ltd. · Jun 2007
X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
K071409 · Imaging Dynamics Company , Ltd. · Jun 2007
XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND
K063246 · Imaging Dynamics Company , Ltd. · Nov 2006