Cleared Special

K043002 - SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR

K043002 is an FDA 510(k) clearance for SEDECAL MOBILE X-RAY UNITS WITH DIGITAL..., 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 17-day FDA review.

K043002 · Sedecal., Sa. · Radiology device
Download Printable Device Report (PDF)
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Nov 2004
Decision
17d
Days
Class 2
Risk

K043002 is an FDA 510(k) clearance for the SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Sedecal., Sa. (Deer Field, US). The FDA issued a Cleared decision on November 18, 2004 after a review of 17 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 - K043002

510(k) Number K043002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date November 18, 2004
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
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 185
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K043002.
AJEX 9015/135H PORTABLE X-RAY
K052341 · Jpi America, Inc. · Oct 2005
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MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
K043062 · Source-Ray, Inc. · Dec 2004
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
K042866 · Ge Healthcare Technologies · Nov 2004
PRACTIX CONVENIO
K042368 · Philips Medical Systems North America Co. · Oct 2004
DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
K042361 · Sedecal USA, Inc. · Sep 2004