Cleared Traditional

K170858 - FDR AQRO (DR-XD 1000) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170858 · Fujifilm Medical Systems U.S.A, Inc. · Radiology device
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Apr 2017
Decision
33d
Days
Class 2
Risk

K170858 is an FDA 510(k) clearance for the FDR AQRO (DR-XD 1000). Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Stamford, US). The FDA issued a Cleared decision on April 24, 2017 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Systems U.S.A, Inc. devices

Submission Details

510(k) Number K170858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2017
Decision Date April 24, 2017
Days to Decision 33 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
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 233
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