Cleared Abbreviated

UNISIGHT SYSTEM WITH UNIGATE (K023394) - FDA 510(k) Clearance

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

K023394 · Electronic Business Machine Co., Ltd. (Ebm) · Radiology device
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Jan 2003
Decision
90d
Days
Class 2
Risk

K023394 is an FDA 510(k) clearance for the UNISIGHT SYSTEM WITH UNIGATE. 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 January 7, 2003 after a review of 90 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K023394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2002
Decision Date January 07, 2003
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 757
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K023394.
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
K030781 · Eastman Kodak Company · May 2003
SYNGO COLONOGRAPHY SOFTWARE PACKAGE
K030982 · Siemens Medical Solutions USA, Inc. · Apr 2003
CENTRICITY PACS PLUS
K023557 · GE Medical Systems · Nov 2002
E.CAM COMPUTER / E.SOFT WORKSTATION
K023190 · Siemens Medical Solutions USA, Inc. · Oct 2002
ADVANTAGE WORKSTATION 4.1
K020483 · GE Medical Systems · Feb 2002