Cleared Traditional

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

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

About This 510(k) Submission

K233119 is an FDA 510(k) clearance for the 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T, a Digital Pathology Display (Class II — Special Controls, product code PZZ), submitted by Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 28, 2024, 458 days after receiving the submission on September 27, 2023. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K233119 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PZZ — Digital Pathology Display
Device Class Class II — 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.