Cleared Traditional

K132610 - 5MP GRAYSCALE LCD DISPLAY

K132610 is an FDA 510(k) clearance for 5MP GRAYSCALE LCD DISPLAY, manufactured by Shenzhen Beacon Display Technology Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K132610 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
15d
Days
Class 2
Risk

K132610 is an FDA 510(k) clearance for the 5MP GRAYSCALE LCD DISPLAY. 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 Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on September 4, 2013 after a review of 15 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 Shenzhen Beacon Display Technology Co., Ltd. devices

FDA 510(k) Submission Details - K132610

510(k) Number K132610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2013
Decision Date September 04, 2013
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 1204
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K132610.
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
K132636 · Smith & Nephew, Inc. · Oct 2013
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
K131977 · Ge Healthcare · Sep 2013
JUSHA-C31 MEDICAL DISPLAY
K131389 · Nanjing Jusha Display Technology Co., Ltd. · Sep 2013
EZDENTI-I
K131594 · Ewoosoft Co., Ltd. · Aug 2013
EZ3D-I, E3
K131616 · Ewoosoft Co., Ltd. · Aug 2013
JUSHA-M32 MEDICAL DISPLAY
K131391 · Nanjing Jusha Display Technology Co., Ltd. · Aug 2013