Cleared Abbreviated

K023394 - UNISIGHT SYSTEM WITH UNIGATE

K023394 is an FDA 510(k) clearance for UNISIGHT SYSTEM WITH UNIGATE, 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 90-day FDA review.

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.

FDA 510(k) Submission Details - K023394

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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 2284
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K023394.
BARCO MEDIS 5MP2 AURA
K023533 · Barco N.V. · Jan 2003
JUPITER PROCESSING AND REVIEW WORKSTATION
K024137 · Ge Medical Systems, Inc. · Jan 2003
PACSPLUS
K023460 · Medical Standard Co., Ltd. · Jan 2003
HCP DICOM NET
K023467 · Softlink International, Inc. · Jan 2003
UNIPACS WORKSTATION
K023476 · Universal Pacs, Inc. · Jan 2003
AMALGA PACS
K023246 · Global Care Solutions, S.A. · Dec 2002
K023394 · UNISIGHT SYSTEM WITH UNIGATE
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