Cleared Traditional

K081056 - 21.3 (54CM) 3M COLOR LCD MONITOR CCL354...

K081056 is the FDA 510(k) clearance for 21.3 (54CM) 3M COLOR LCD MONITOR CCL354... by Totoku Electric Co., Ltd.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K081056 · Totoku Electric Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
51d
Days
Class 2
Risk

K081056 is an FDA 510(k) clearance for the 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A). 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 June 4, 2008 after a review of 51 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 K081056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date June 04, 2008
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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 K081056.
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
K081843 · Aloka Co., Ltd. · Jul 2008
SYNGO IMAGING (VERSION V31)
K081734 · Siemens AG Medical Solutions · Jul 2008
21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
K081055 · Totoku Electric Co., Ltd. · Jun 2008
FUJIFILM FCR VIEW, MODEL CR-VW674
K081308 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2008
19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
K080951 · Totoku Electric Co., Ltd. · May 2008
15-INCH (38 CM) COLOR LCD MONITOR CDL1576A
K080952 · Totoku Electric Co., Ltd. · May 2008