FDA.reportPublic FDA data

Beacon

Primary DI
06970027820902
Brand
Beacon
Company
Shenzhen Beacon Display Technology Co., Ltd.
Model
C811W
Device description
8MP Color LCD Display
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PZZDigital Pathology Display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZZDigital Pathology DisplayPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2331190008MP Color LCD Displays C811W, C811WT, PA27 and PA27TShenzhen Beacon Display Technology Co., Ltd.2024-12-28PZZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970027820902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970027820902069700278209026970027820902

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526873362
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970027821411BeaconC822W2026-05-27
06970027820940BeaconC811WT2025-03-18
06970027821077BeaconPA27T2025-03-18
06970027821084BeaconPA272025-03-18
06970027820759BeaconC310S2024-05-16
06970027820797BeaconC616W2024-05-16
06970027820971BeaconC316S2024-05-16
06970027821015BeaconG310S2024-05-16
06970027821022BeaconG316S2024-05-16
06970027820322BeaconS4212024-09-30
06970027820339BeaconS271P2024-09-30
06970027820407BeaconE24212024-09-30
06970027820476BeaconS2785P2024-09-30
06970027820537BeaconS3281P2024-09-30
06970027820605BeaconE24222024-09-30
06970027820636BeaconS3221P2024-09-30
06970027820643BeaconS5583P2024-09-30
06970027820667BeaconS3285P2024-09-30
06970027820810BeaconS3221P-3D2024-09-30
06970027820827BeaconS3285P-3D2024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970027820940BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027821077BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027821084BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
05051663010467EprediaSHANDON DIAGNOSTICS LIMITEDPZZ2025-03-10
05415334033665BarcoBarco NVPZZ2021-07-05
05415334033603BarcoBarco NVPZZ2021-07-05
05415334001732BarcoBarco NVPZZ2021-06-28