Cleared Traditional

K083332 - MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR

K083332 is an FDA 510(k) clearance for MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, manufactured by Nec Display Solutions , Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K083332 · Nec Display Solutions , Ltd. · Radiology device
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Jan 2009
Decision
58d
Days
Class 2
Risk

K083332 is an FDA 510(k) clearance for the MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK. 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 Nec Display Solutions , Ltd. (Taipe, TW). The FDA issued a Cleared decision on January 9, 2009 after a review of 58 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 Nec Display Solutions , Ltd. devices

FDA 510(k) Submission Details - K083332

510(k) Number K083332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date January 09, 2009
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
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 1236
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K083332.
MAMMODIAGNOST VU
K083740 · Philips Medical Systems Nederland B.V. · Feb 2009
COLOR LCD MONITOR, RADIFORCE RX320
K090045 · Eizo Nanao Corporation · Jan 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · Carestream Health, Inc. · Dec 2008
IMAGE-ARENA APPLICATIONS
K083348 · Tomtec Imaging Systems GmbH · Dec 2008
SYNGO IMAGING XS
K082430 · Siemens AG Medical Solutions · Nov 2008