Cleared Traditional

K042023 - FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVI...

K042023 is the FDA 510(k) clearance for FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVI... by Fujifilm Medical System U.S.A., Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K042023 · Fujifilm Medical System U.S.A., Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
28d
Days
Class 2
Risk

K042023 is an FDA 510(k) clearance for the FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on August 25, 2004 after a review of 28 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fujifilm Medical System U.S.A., Inc. devices

Submission Details

510(k) Number K042023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2004
Decision Date August 25, 2004
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 Consultant

Underwriters Laboratories, Inc.
JEFFERY RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K042023.
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K042602 · Ge Medical Systems, LLC · Jan 2005
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
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CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
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K031447 · Canon, Inc. · May 2003