Cleared Traditional

K093816 - DIGITAL RADIOGRAPHY SYSTEM

K093816 is an FDA 510(k) clearance for DIGITAL RADIOGRAPHY SYSTEM, manufactured by Medien International Co, Ltd.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K093816 · Medien International Co, Ltd. · Radiology device
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Oct 2010
Decision
298d
Days
Class 2
Risk

K093816 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Medien International Co, Ltd. (Echo, US). The FDA issued a Cleared decision on October 5, 2010 after a review of 298 days - an extended review 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: 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 Medien International Co, Ltd. devices

FDA 510(k) Submission Details - K093816

510(k) Number K093816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2009
Decision Date October 05, 2010
Days to Decision 298 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
191d slower than avg
Panel avg: 107d · This submission: 298d
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 206
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K093816.
AERODR SYSTEM
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FDR IMAGE STITCHING OPTION
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DX-D 300
K103050 · Agfa Healthcare N.V. · Oct 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
K092830 · VATECH Co., Ltd. · Jul 2010
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · Carestream Health, Inc. · Jul 2009
SEDECAL, MILLENNIUM PLUS
K090279 · Sedecal., Sa. · Mar 2009