FDA.reportPublic FDA data

Beacon

Primary DI
06970027821145
Brand
Beacon
Company
Shenzhen Beacon Display Technology Co., Ltd.
Model
MB5MP
Device description
5MP Monochrome LCD Monitor
Published
2024-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PGYDisplay, Diagnostic Radiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGYDisplay, Diagnostic RadiologyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233897000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2338970005MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)Shenzhen Beacon Display Technology Co., Ltd.2024-02-06PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970027821145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970027821145069700278211456970027821145

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

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
06970027820902BeaconC811W2025-03-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047069300RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047069362RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072676RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072683RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072843RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072904RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072935RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072973RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073055RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073185RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073208RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073277RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073338RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073376RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073444RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073468RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073475RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073611RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073673RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073703RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073819RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073871RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073895RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074311RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074373RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074441RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074588RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074601RadiForce®EIZO CORPORATIONPGY2026-07-22
08809241513148CW60NWIDE corporationPGY2026-07-16
08809241513155CL24NWIDE corporationPGY2026-07-16