Cleared Abbreviated

K071166 - UNIWEB, VERSION 5.0

K071166 is an FDA 510(k) clearance for UNIWEB, manufactured by Electronic Business Machine Co., Ltd. (Ebm). The device is a Class 2 Radiology device with product code LLZ cleared through the Abbreviated 510(k) pathway after a 88-day FDA review.

K071166 · Electronic Business Machine Co., Ltd. (Ebm) · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2007
Decision
88d
Days
Class 2
Risk

K071166 is an FDA 510(k) clearance for the UNIWEB, VERSION 5.0. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Electronic Business Machine Co., Ltd. (Ebm) (Honolulu, US). The FDA issued a Cleared decision on July 23, 2007 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Standards-verified equivalence. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Electronic Business Machine Co., Ltd. (Ebm) devices

FDA 510(k) Submission Details - K071166

510(k) Number K071166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2007
Decision Date July 23, 2007
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1355
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