Cleared Special

K173299 - DRAGON X SPSL4HC

K173299 is the FDA 510(k) clearance for DRAGON X SPSL4HC by Sedecal., Sa.. It is a Class 2 Radiology device (product code IZL) cleared through the Special 510(k) pathway after a 101-day FDA review.

K173299 · Sedecal., Sa. · Radiology device
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Jan 2018
Decision
101d
Days
Class 2
Risk

K173299 is an FDA 510(k) clearance for the DRAGON X SPSL4HC, DRAGON X SPSL8HC. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Sedecal., Sa. (Algete, ES). The FDA issued a Cleared decision on January 26, 2018 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sedecal., Sa. devices

Submission Details

510(k) Number K173299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2017
Decision Date January 26, 2018
Days to Decision 101 days
Submission Type Special
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
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

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

Kamm & Associates
Daniel Kamm

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.

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