FDA.reportPublic FDA data

Beacon

Primary DI
06970027821411
Brand
Beacon
Company
Shenzhen Beacon Display Technology Co., Ltd.
Model
C822W
Device description
LCD Monitor
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K253242000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253242000LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.2025-10-29PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970027821411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970027821411069700278214116970027821411

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.

Regulatory Flags#

DUNS number
526873362
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06970027820827BeaconS3285P-3D2024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334057265Nio Color 8MPBarco NVPGY2026-05-07
04719875210211DIVADIVA LABORATORIES, LTD.PGY2026-04-21
04719875210525DIVADIVA LABORATORIES, LTD.PGY2026-04-21
05415334060159Nio 5.8MP GrayBarco NVPGY2025-12-01
08806096660263LGLG Electronics Inc.PGY2025-09-19
04995047070542RadiForce®EIZO CORPORATIONPGY2025-09-12
04995047060727RadiForce®EIZO CORPORATIONPGY2025-09-08
04995047060567RadiForce®EIZO CORPORATIONPGY2025-09-08
04995047060611RadiForce®EIZO CORPORATIONPGY2025-09-08
04995047060666RadiForce®EIZO CORPORATIONPGY2025-09-08
14995047060724RadiForce®EIZO CORPORATIONPGY2025-09-08
04995047060758RadiForce®EIZO CORPORATIONPGY2025-09-08
05415334054967Nio 5.8MP ColorBarco NVPGY2025-08-11
05415334054974Nio 5.8MP ColorBarco NVPGY2025-08-11
05415334054981Nio 5.8MP GrayBarco NVPGY2025-08-11
05415334054998Nio 5.8MP GrayBarco NVPGY2025-08-11
05415334058415BarcoBarco NVPGY2025-08-05
04995047068259RadiForce®EIZO CORPORATIONPGY2025-07-11
04995047052814RadiForce®EIZO CORPORATIONPGY2025-07-11
04995047064404RadiForce®EIZO CORPORATIONPGY2025-07-11
04995047065661RadiForce®EIZO CORPORATIONPGY2025-07-11
04995047067849RadiForce®EIZO CORPORATIONPGY2025-07-11
14995047068256RadiForce®EIZO CORPORATIONPGY2025-07-11
05415334049895Coronis Fusion 4MPBarco NVPGY2025-04-16
05415334049901Coronis Fusion 4MPBarco NVPGY2025-04-16
05415334049925Coronis Fusion 6MPBarco NVPGY2025-04-16
05415334049932Coronis Fusion 6MPBarco NVPGY2025-04-16
04995047068044RadiForce®EIZO CORPORATIONPGY2024-12-05
04995047068341RadiForce®EIZO CORPORATIONPGY2024-12-05
14995047068041RadiForce®EIZO CORPORATIONPGY2024-12-05