Cleared Traditional

K083332 - MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 2241
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K083332.
LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD
K083916 · Nec Display Solutions , Ltd. · Jan 2009
MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
K083907 · Nec Display Solutions , Ltd. · Jan 2009
IMAGESVR PACS
K082808 · Jaguar Technology Limited · Jan 2009
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
K082526 · Mri Cardiac Services, Incorporated · Jan 2009
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · Carestream Health, Inc. · Dec 2008
IMAGE-ARENA APPLICATIONS
K083348 · Tomtec Imaging Systems GmbH · Dec 2008