Cleared Traditional

K233119 - 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

K233119 is an FDA 510(k) clearance for 8MP Color LCD Displays C811W, manufactured by Shenzhen Beacon Display Technology Co., Ltd.. The device is a Class 2 Pathology device with product code PZZ cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K233119 · Shenzhen Beacon Display Technology Co., Ltd. · Pathology device
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Dec 2024
Decision
458d
Days
Class 2
Risk

K233119 is an FDA 510(k) clearance for the 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. Classified as Digital Pathology Display (product code PZZ), Class II - Special Controls.

Submitted by Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 28, 2024 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Shenzhen Beacon Display Technology Co., Ltd. devices

FDA 510(k) Submission Details - K233119

510(k) Number K233119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date December 28, 2024
Days to Decision 458 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
380d slower than avg
Panel avg: 78d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PZZ Device Classification - Class 2, Special Controls

Product Code PZZ Digital Pathology Display
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition The Digital Pathology Display Device Is Intended For In Vitro Diagnostic Use To Display Digital Images Of Histopathology Slides Acquired From Fda-cleared Whole-slide Imaging Scanners That Are Used For Review And Interpretation By Trained Pathologists.
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 Pathology devices follow this clearance model.