Cleared Traditional

K122454 - FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION

K122454 is an FDA 510(k) clearance for FUJIFILM DUAL ENERGY SUBTRACTION (DES) ..., manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K122454 · Fujifilm Medical System U.S.A., Inc. · Radiology device
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Nov 2012
Decision
99d
Days
Class 2
Risk

K122454 is an FDA 510(k) clearance for the FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on November 20, 2012 after a review of 99 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 Fujifilm Medical System U.S.A., Inc. devices

FDA 510(k) Submission Details - K122454

510(k) Number K122454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2012
Decision Date November 20, 2012
Days to Decision 99 days
Submission Type Traditional
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
8d faster than avg
Panel avg: 107d · This submission: 99d
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 267
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