Cleared Traditional

K942561 - FUJI FCR IMAGE PROCESSING UNIT IP-U515

K942561 is an FDA 510(k) clearance for FUJI FCR IMAGE PROCESSING UNIT IP-U515, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code IXK cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K942561 · Fujifilm Medical System U.S.A., Inc. · Radiology device
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Dec 1994
Decision
206d
Days
Class 2
Risk

K942561 is an FDA 510(k) clearance for the FUJI FCR IMAGE PROCESSING UNIT IP-U515. Classified as System, Imaging, X-ray, Electrostatic (product code IXK), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on December 23, 1994 after a review of 206 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1630 - 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 - K942561

510(k) Number K942561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date December 23, 1994
Days to Decision 206 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
99d slower than avg
Panel avg: 107d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXK Device Classification - Class 2, Special Controls

Product Code IXK System, Imaging, X-ray, Electrostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1630
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 - IXK System, Imaging, X-ray, Electrostatic

All 7
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