Cleared Traditional

DR 100s (K191884) - FDA 510(k) Clearance

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

K191884 · Agfa N.V. · Radiology device
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Aug 2019
Decision
25d
Days
Class 2
Risk

K191884 is an FDA 510(k) clearance for the DR 100s. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Agfa N.V. (Mortsel, BE). The FDA issued a Cleared decision on August 9, 2019 after a review of 25 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 Agfa N.V. devices

Submission Details

510(k) Number K191884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2019
Decision Date August 09, 2019
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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 Consultant

Agfa US Corp.
ShaeAnn Cavanagh

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 - IZL System, X-ray, Mobile

All 94
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K191884.
AcuityPDR
K200726 · Radmedix, LLC · Apr 2020
Soltus 500
K192936 · Sedecal., Sa. · Nov 2019
PhoeniX
K192011 · Sedecal., Sa. · Sep 2019
MobileDiagnost wDR 2.2
K191813 · Sedecal., Sa. · Aug 2019
CMDR 2CW (Multiple models)
K191451 · Minxray, Inc. · Jul 2019
DRX-Revolution Mobile X-ray System
K191025 · Carestream Health, Inc. · May 2019