Cleared Traditional

K133185 - 21.3 INCH (54 CM) COLOR LCD MONITOR CCL...

K133185 is an FDA 510(k) clearance for 21.3 INCH (54 CM) COLOR LCD MONITOR CCL..., manufactured by Jvckenwood Corporation. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K133185 · Jvckenwood Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
47d
Days
Class 2
Risk

K133185 is an FDA 510(k) clearance for the 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358). 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 Jvckenwood Corporation (Yokohama-Shi, Kanagawa, JP). The FDA issued a Cleared decision on December 3, 2013 after a review of 47 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 Jvckenwood Corporation devices

FDA 510(k) Submission Details - K133185

510(k) Number K133185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date December 03, 2013
Days to Decision 47 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
60d faster than avg
Panel avg: 107d · This submission: 47d
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 1203
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K133185.
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
K133511 · Jvckenwood Corporation · Dec 2013
SIDEXIS 4
K132773 · Sirona Dental Systems GmbH · Dec 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
K133181 · Jvckenwood Corporation · Dec 2013
JUSHA-M52C MEDICAL DISPLAY
K131390 · Nanjing Jusha Display Technology Co., Ltd. · Nov 2013
MULTIVIEW
K132316 · Hologic, Inc. · Oct 2013
MAMMOGRAPHY VIEWER SMV658
K132188 · Fujifilm Medical System U.S.A., Inc. · Oct 2013