Cleared Traditional

K033561 - FUJI COMPUTED RADIOGRAPHY (FCR) VELOCIT...

K033561 is the FDA 510(k) clearance for FUJI COMPUTED RADIOGRAPHY (FCR) VELOCIT... 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 14-day FDA review.

K033561 · Fujifilm Medical System U.S.A., Inc. · Radiology device
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Nov 2003
Decision
14d
Days
Class 2
Risk

K033561 is an FDA 510(k) clearance for the FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY 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 November 26, 2003 after a review of 14 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 K033561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2003
Decision Date November 26, 2003
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
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.
SUSAN GILL

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
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