Cleared Special

K173299 - DRAGON X SPSL4HC, DRAGON X SPSL8HC

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

K173299 · Sedecal., Sa. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K173299

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.

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

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.

Regulatory Peers - IZL System, X-ray, Mobile

All 237
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K173299.
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Optima XR240amx, AutoGrid
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MDR17 Mobile Direct Radiographic System
K173018 · Del Medical, Inc. · Nov 2017
MobileDiagnost M50
K173187 · Philips India Limited · Nov 2017
K173299 · DRAGON X SPSL4HC, DRAGON X SPSL8HC
Download PDF FDA Summary Sedecal., Sa.