Cleared Traditional

K111496 - 21.3 INCH (54CM) MONOCHROME DIGITAL MAM...

K111496 is the FDA 510(k) clearance for 21.3 INCH (54CM) MONOCHROME DIGITAL MAM... by Totoku Electric Co., Ltd.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K111496 · Totoku Electric Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
118d
Days
Class 2
Risk

K111496 is an FDA 510(k) clearance for the 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR. 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 September 26, 2011 after a review of 118 days - within the typical 510(k) review window.

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 K111496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2011
Decision Date September 26, 2011
Days to Decision 118 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
11d slower than avg
Panel avg: 107d · This submission: 118d
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 K111496.
CARESTREAM PACS
K110919 · Carestream Health, Inc. · Oct 2011
CORONIS 5MP
K111990 · Barco N.V. · Oct 2011
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
K112439 · Fujifilm Medical System U.S.A., Inc. · Oct 2011
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
K111641 · Materialise NV · Sep 2011
CORONIS FUSION 4MP DL
K111989 · Barco N.V. · Sep 2011
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
K103308 · KARL STORZ Endoscopy-America, Inc. · Aug 2011