Cleared Abbreviated

PORTABLE X-RAY UNITS (K020436) - FDA 510(k) Clearance

Also marketed or referenced as:
MODELS SP-HF-2.8 & SP-HF-4.0

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K020436 · Sedecal., Sa. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
14d
Days
Class 2
Risk

K020436 is an FDA 510(k) clearance for the PORTABLE X-RAY UNITS. 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 February 22, 2002 after a review of 14 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sedecal., Sa. devices

Submission Details

510(k) Number K020436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2002
Decision Date February 22, 2002
Days to Decision 14 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Standards-based clearance path.

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 Peers - IZL System, X-ray, Mobile

All 95
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K020436.
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MX MOBILE X-RAY SYSTEM
K862452 · Philips Medical Systems (Cleveland), Inc. · Jul 1986