FDA.reportPublic FDA data

Hisense

Primary DI
06933741405350
Brand
Hisense
Company
Qingdao Hisense Medical Equipment Co., Ltd.
Model
HMD6C30D
Device description
LCD Monitor
Published
2022-12-15
Public version status
Update
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
K222208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222208000Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DQingdao Hisense Medical Equipment Co., Ltd.2022-11-17PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06933741405350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06933741405350069337414053506933741405350

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544312126
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06933741401642HisenseXP5-1E2024-05-31
06933741401765HisenseDC7-2E2024-05-31
06933741401864HisenseL21-9E2024-05-31
06933741402946HisenseHD802024-05-31
06933741403042HisenseHD822024-05-31
06933741403684HisenseHD752024-05-31
06933741403783HisenseHD782024-05-31
06933741401796HisenseDE10-3E 2024-03-19
06933741401871HisenseECL11-4E2024-03-19
06933741405336HisenseHMD4C27S2022-12-15
06933741405343HisenseHMD2G21S2022-12-15
06933741405367HisenseHMD3G21S2022-12-15
06933741405374HisenseHMD2C21A2022-12-15
06933741405183HisenseHME8C272023-09-11
06933741405237HisenseHMD3C21S2022-09-13
06933741405244HisenseHMD5G21S2022-09-13
06933741401673HisenseL15-5EB2024-03-19
06933741401697HisenseL12-3EB2024-03-19
06933741401710HisenseE9-4EL2024-03-19
06933741401727HisenseE9-4E2024-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334061750BarcoBarco NVPGY2026-06-02
06970027821411BeaconShenzhen Beacon Display Technology Co., Ltd.PGY2026-05-27
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