Cleared Abbreviated

CHILI VIDEO, CHILI VIDEOPRO (K000411) - FDA 510(k) Clearance

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

K000411 · Steinbeis-Transferzentrum Medizinische Informatik · Radiology device
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Apr 2000
Decision
66d
Days
Class 2
Risk

K000411 is an FDA 510(k) clearance for the CHILI VIDEO, CHILI VIDEOPRO. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Steinbeis-Transferzentrum Medizinische Informatik (Bedford, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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 Steinbeis-Transferzentrum Medizinische Informatik devices

Submission Details

510(k) Number K000411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2000
Decision Date April 14, 2000
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

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