Cleared Traditional

FLAT PANEL DISPLAY, ME183L (K030272) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030272 · Totoku Electric Co., Ltd. · Radiology device
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Apr 2003
Decision
88d
Days
Class 2
Risk

K030272 is an FDA 510(k) clearance for the FLAT PANEL DISPLAY, ME183L. 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 Totoku Electric Co., Ltd. (Nagano-Ken, JP). The FDA issued a Cleared decision on April 25, 2003 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 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 Totoku Electric Co., Ltd. devices

Submission Details

510(k) Number K030272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date April 25, 2003
Days to Decision 88 days
Submission Type Traditional
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
Predicate-based equivalence. No clinical trials required.

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 730
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K030272.
UNDECIDED
K041484 · Siemens Medical Solutions USA, Inc. · Jul 2004
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
E.CAM COMPUTER / E.SOFT WORKSTATION
K023190 · Siemens Medical Solutions USA, Inc. · Oct 2002
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · Eastman Kodak Company · Aug 2001