Cleared Traditional

K102408 - DIGITAL DIAGNOSTIC X-RAY SYSTEM

K102408 is an FDA 510(k) clearance for DIGITAL DIAGNOSTIC X-RAY SYSTEM, manufactured by DRGEM Corporation. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K102408 · DRGEM Corporation · Radiology device
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Dec 2010
Decision
126d
Days
Class 2
Risk

K102408 is an FDA 510(k) clearance for the DIGITAL DIAGNOSTIC X-RAY SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by DRGEM Corporation (Echo, US). The FDA issued a Cleared decision on December 27, 2010 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all DRGEM Corporation devices

FDA 510(k) Submission Details - K102408

510(k) Number K102408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2010
Decision Date December 27, 2010
Days to Decision 126 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 190
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K102408.
AERODR SYSTEM WITH P-21
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K112670 · Agfa Healthcare N.V. · Oct 2011
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K103448 · Ge Medical Systems, LLC · Aug 2011
AERODR SYSTEM
K102349 · Konica Minolta Medical & Graphic, Inc. · Nov 2010
FDR IMAGE STITCHING OPTION
K101686 · Fujifilm Medical System U.S.A., Inc. · Oct 2010
DX-D 300
K103050 · Agfa Healthcare N.V. · Oct 2010