Cleared Traditional

K063197 - 21.3 INCH (54CM) MONOCHROME LCD MONITOR...

K063197 is the FDA 510(k) clearance for 21.3 INCH (54CM) MONOCHROME LCD MONITOR... by Totoku Electric Co., Ltd.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K063197 · Totoku Electric Co., Ltd. · Radiology device
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Nov 2006
Decision
41d
Days
Class 2
Risk

K063197 is an FDA 510(k) clearance for the 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2). 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. (Ueda, JP). The FDA issued a Cleared decision on November 30, 2006 after a review of 41 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 K063197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2006
Decision Date November 30, 2006
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
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 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K063197.
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