FDA.reportPublic FDA data

Vividimage 4K

Primary DI
00724995195106
Brand
Vividimage 4K
Company
BLACK DIAMOND VIDEO, INC.
Model
RLM314K2
Catalog number
RLM314K2
Device description
The Vividimage 31-inch 4K Surgical Display, Generator 2, is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQMCAMERA, SURGICAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995195106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995195106007249951951067249951951060724995195106

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
556373053
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995245054HexaVueHexaVue FocusXEHFSLC2025-10-17
00724995245061HexaVueHexaVue FocusXEHFSLCAMC2025-10-17
00724995220587HexaVueHexaVue IPXQHPSLC2024-02-08
00724995220594HexaVueHexaVue IPXQHPILCC2024-02-08
00724995198503HexaVueHexaVue SCC 1.0XQHILCC12021-03-31
00724995198497HexaVueHexaVue-SLC 1.0XQHLC12020-09-04
00724995198459FREE5Free5 CameraRLQ1080FCS2021-04-23
00724995209162Uretero1UROSD101UROSD1012022-06-10
00724995209179Uretero1URORD101URORD1012022-06-10
00724995209186Vision1VIS101VIS1012022-06-10
00724995198473NAIDSS-SCCXQSILCC12021-04-23
00724995199135Harmony iQHarmony iQ 2800RLQ2000SLC2021-04-23
00724995199142Harmony iQHarmony iQ 3600RLQ3600SLC2021-04-23
00724995163723NAIDSS-SLC Version 8XQSLC12019-02-28
00724995153083NAIDSS-SLCXQSLC12017-06-06
00724995218799Vividimage W 4KRLM65MG4K3RLM65MG4K32022-08-19
00724995195113Vividimage 4KRLM314K3RLM314K32021-04-23
00724995195137Vividimage 4KRLM314K3NPWRRLM314K3NPWR2021-04-23
00724995195069Vividimage D HDRLM27HD3RLM27HD32021-03-31
00724995195090Vividimage D HDRLM27HD3NPWRRLM27HD3NPWR2021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170681SONYSONY CORPORATIONKQM2025-06-24
04548736170704SONYSONY CORPORATIONKQM2025-06-24
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15