Cleared Special

K103522 - SEDECAL

K103522 is an FDA 510(k) clearance for SEDECAL, 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 56-day FDA review.

K103522 · Sedecal., Sa. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
56d
Days
Class 2
Risk

K103522 is an FDA 510(k) clearance for the SEDECAL. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Sedecal., Sa. (Naples, US). The FDA issued a Cleared decision on January 26, 2011 after a review of 56 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. 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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K103522

510(k) Number K103522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2010
Decision Date January 26, 2011
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 Peers - IZL System, X-ray, Mobile

All 130
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K103522.
SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
K101517 · Sedecal., Sa. · Aug 2011
MOBILEDIAGNOST WDR
K111725 · Sedecal., Sa. · Jul 2011
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
K103476 · Ge Medical Systems, LLC · Jun 2011
DX-D 100
K103597 · Agfa Healthcare N.V. · Jan 2011
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
K090268 · Shimadzu Corp. · Jun 2009
EASY MOVING PLUS, SM-XXHF-YY
K090322 · Sedecal., Sa. · Mar 2009