Cleared Traditional

K052312 - WIDE 5MP (MAMMO) LCD MONITOR SYSTEM

K052312 is an FDA 510(k) clearance for WIDE 5MP (MAMMO) LCD MONITOR SYSTEM, manufactured by Wide Corporation. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K052312 · Wide Corporation · Radiology device
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Oct 2005
Decision
44d
Days
Class 2
Risk

K052312 is an FDA 510(k) clearance for the WIDE 5MP (MAMMO) LCD MONITOR SYSTEM. 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 Wide Corporation (Denton, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 44 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 Wide Corporation devices

FDA 510(k) Submission Details - K052312

510(k) Number K052312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2005
Decision Date October 07, 2005
Days to Decision 44 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
63d faster than avg
Panel avg: 107d · This submission: 44d
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 1796
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K052312.
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
K052775 · Siemens AG Medical Solutions · Oct 2005
FOURSIGHT VIEWTOOL IMAGE VIEWER
K052895 · Siemens Medical Solutions USA, Inc. · Oct 2005
REFORMAT GATEWAY
K052284 · Infinitt Co., Ltd. · Oct 2005
ETIAM STAR PACS COMPONENTS
K052358 · Etiam, S.A. · Oct 2005
COLOR CORONIS 2MP-21 AND MFCD 2321
K052352 · Barcoview · Sep 2005
E-2320 PA S
K052529 · Barcoview · Sep 2005