Cleared Traditional

K090947 - 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGR...

K090947 is the FDA 510(k) clearance for 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGR... by Totoku Electric Co., Ltd.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 500-day FDA review.

K090947 · Totoku Electric Co., Ltd. · Radiology device
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Aug 2010
Decision
500d
Days
Class 2
Risk

K090947 is an FDA 510(k) clearance for the 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL21.... 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 August 16, 2010 after a review of 500 days - an unusually long review period, suggesting complex equivalence evaluation.

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-to-high 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 K090947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2009
Decision Date August 16, 2010
Days to Decision 500 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
393d slower than avg
Panel avg: 107d · This submission: 500d
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.

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