FDA.report

Nio 5.8MP Gray

Primary DI
05415334028401
Brand
Nio 5.8MP Gray
Company
Barco NV
Model
MDNG-6221
Catalog number
K9300371B
Device description
MDNG-6221 NC EM
Published
2022-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PGYDisplay, Diagnostic Radiology

Product Code Classifications

CodeDeviceSpecialtyClass
PGYDisplay, Diagnostic RadiologyRadiology2

Premarket Submissions

SubmissionSupplement
K170476000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K170476000Nio Color 5.8MP (MDNC-6121)Barco N.V.2017-03-28PGY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05415334028401PrimaryGS10

GMDN Terms

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

Contacts

PhoneEmail
866-302-7939service.medical.usa@barco.com

Regulatory Flags

DUNS number
371618773
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 DIBrandModelCatalogPublished
05415334050020BarcoMDSC-8532 K93530182025-12-22
05415334050013BarcoMDSC-8532K93530192025-12-01
05415334053045Eonis 3DMDRC-8127K9301153A2X2025-12-01
05415334060159Nio 5.8MP GrayMDNG-6221K9300375C1X2025-12-01
05415334054967Nio 5.8MP ColorMDNC-6121K9300360C1X2025-08-11
05415334054974Nio 5.8MP ColorMDNC-6121K9300361C1X2025-08-11
05415334054981Nio 5.8MP GrayMDNG-6221K9300370C1X2025-08-11
05415334054998Nio 5.8MP GrayMDNG-6221K9300372C1X2025-08-11
05415334058415BarcoIWT 2.4.xK93082542025-08-05
05415334051133SterisVividImage 32 4K MiniLEDRLM324KMINI2025-06-05
05415334053458BarcoMNA-4406003014792025-06-04
05415334053472BarcoMNA-1206003014812025-06-04
05415334053663BarcoMNA-2406003014822025-06-04
05415334053670BarcoMNA-4206003060272025-06-04
05415334049895Coronis Fusion 4MPMDCC-4430K9301626B2X2025-04-16
05415334049901Coronis Fusion 4MPMDCC-4430K9301628B2X2025-04-16
05415334049925Coronis Fusion 6MPMDCC-6530K9301636B2X2025-04-16
05415334049932Coronis Fusion 6MPMDCC-6530K9301638B2X2025-04-16
05415334053717BarcoMDRC-2422K9356038A1X2025-04-14
05415334053724BarcoMDRC-2422K9356039A1X2025-04-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05415334060159Nio 5.8MP GrayBarco NVPGY2025-12-01
08806096660263LGLG Electronics Inc.PGY2025-09-19
04995047070542RadiForce®EIZO CORPORATIONPGY2025-09-12
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
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
14995047068041RadiForce®EIZO CORPORATIONPGY2024-12-05
04995047068167RadiForce®EIZO CORPORATIONPGY2024-12-05
04995047068242RadiForce®EIZO CORPORATIONPGY2024-12-05
14995047068348RadiForce®EIZO CORPORATIONPGY2024-12-05
05415334050358Nio Color 2MPBarco NVPGY2024-11-27
05415334050365Nio Color 2MPBarco NVPGY2024-11-27
05415334050372Nio Color 3MPBarco NVPGY2024-11-27
05415334050389Nio Color 3MPBarco NVPGY2024-11-27