Cleared Traditional

K081945 - 21.3-INCH (54CM) MONOCHROME LCD MONITOR...

K081945 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 66-day FDA review.

K081945 · Totoku Electric Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
66d
Days
Class 2
Risk

K081945 is an FDA 510(k) clearance for the 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A). 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, JP). The FDA issued a Cleared decision on September 12, 2008 after a review of 66 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 K081945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2008
Decision Date September 12, 2008
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
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 K081945.
COLOR LCD MONITOR
K082663 · Eizo Nanao Corporation · Oct 2008
AW SERVER
K081985 · Ge Medical Systems, LLC · Sep 2008
ULTRAEXTEND USWS-900A
K082596 · Toshiba America Medical Systems, In.C · Sep 2008
QUANTRA
K082483 · Hologic, Inc. · Sep 2008
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
K081512 · Medtronic Navigation, Inc. · Jul 2008
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
K081843 · Aloka Co., Ltd. · Jul 2008