Cleared Traditional

K062743 - UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0

K062743 is an FDA 510(k) clearance for UNISIGHT MAMMOGRAPHY VIEWER, manufactured by Electronic Business Machine Co., Ltd. (Ebm). The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K062743 · Electronic Business Machine Co., Ltd. (Ebm) · Radiology device
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Oct 2006
Decision
47d
Days
Class 2
Risk

K062743 is an FDA 510(k) clearance for the UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0. 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 October 31, 2006 after a review of 47 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. 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 - K062743

510(k) Number K062743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2006
Decision Date October 31, 2006
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 107d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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