Cleared Traditional

K103597 - DX-D 100

K103597 is an FDA 510(k) clearance for DX-D 100, manufactured by Agfa Healthcare N.V.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K103597 · Agfa Healthcare N.V. · Radiology device
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Optimized for regulatory review, auditing and printing
Jan 2011
Decision
26d
Days
Class 2
Risk

K103597 is an FDA 510(k) clearance for the DX-D 100. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Agfa Healthcare N.V. (Greenville, US). The FDA issued a Cleared decision on January 3, 2011 after a review of 26 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 Healthcare N.V. devices

FDA 510(k) Submission Details - K103597

510(k) Number K103597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2010
Decision Date January 03, 2011
Days to Decision 26 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
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IZL Device Classification - Class 2, Special Controls

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

Regulatory Technology Services, LLC
MARK JOB

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 118
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