Cleared Traditional

K063199 - 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)

K063199 is an FDA 510(k) clearance for 21.3-INCH (54CM) COLOR LCD MONITOR CDL2..., manufactured by Totoku Electric Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K063199 · Totoku Electric Co., Ltd. · Radiology device
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Dec 2006
Decision
45d
Days
Class 2
Risk

K063199 is an FDA 510(k) clearance for the 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2). 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 December 4, 2006 after a review of 45 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

FDA 510(k) Submission Details - K063199

510(k) Number K063199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2006
Decision Date December 04, 2006
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
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 1899
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K063199.
VISUALASE ENVISION SOFTWARE SYSTEM
K063505 · Biotex, Inc. · Dec 2006
NOVAPACS
K063153 · Novarad Corp. · Dec 2006
20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)
K063200 · Totoku Electric Co., Ltd. · Dec 2006
DEL-IMS
K063188 · Del Medical Imaging Corp. · Nov 2006
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)
K063197 · Totoku Electric Co., Ltd. · Nov 2006
21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)
K063198 · Totoku Electric Co., Ltd. · Nov 2006