FDA.reportPublic FDA data

Coronis OneLook

Primary DI
05415334046511
Brand
Coronis OneLook
Company
Barco NV
Model
MDMC-32133
Catalog number
K9301401A2X
Device description
MDMC-32133 E
Published
2024-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K242008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242008000Coronis OneLookBarco N.V.2024-08-02PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415334046511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334046511054153340465115415334046511

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

Contacts#

Phone, Email table
PhoneEmail
+1 866-302-7939service.medical.usa@barco.com

Regulatory Flags#

DUNS number
371618773
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415334001671BarcoMDSC-8255K9307933022020-07-29
05415334001879BarcoMDSC-8255K9307930022020-07-29
05415334001886BarcoMDRC-2222K93079432020-07-29
05415334001961BarcoMDSC-8255K93079322020-07-29
05415334001978BarcoMDSC-2324K93079482020-07-29
05415334002098BarcoMDSC-2326K93079512020-07-29
05415334002104BarcoMDSC-2326K93079522020-07-29
05415334002227BarcoMDSC-2326K93079542020-07-29
05415334002913BarcoMDSC-2326K9307951B2020-07-29
05415334002920BarcoMDSC-2326K9307954B2020-07-29
05415334002982BarcoMDSC-8255K93520212020-07-29
05415334002999BarcoMDSC-8255K93520222020-07-29
05415334020948BarcoMDRC-2222K9307944BR2020-07-29
05415334023246BarcoMDRC-2222K9307947BR2020-07-29
05415334026537BarcoMDSC-8255K9352021B2020-07-29
05415334026544BarcoMDSC-8255K9307931B2020-07-29
05415334026551BarcoMDSC-8255K930793002B2020-07-29
05415334026612BarcoMDSC-8255K930793302B2020-07-29
05415334026629BarcoMDSC-8255K9307932B2020-07-29
05415334026636BarcoMDSC-8255K9352022B2020-07-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04995047072683RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072843RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072904RadiForce®EIZO CORPORATIONPGY2026-07-22
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04995047072973RadiForce®EIZO CORPORATIONPGY2026-07-22
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04995047073185RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073208RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073277RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073338RadiForce®EIZO CORPORATIONPGY2026-07-22
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04995047073444RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073468RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073475RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073611RadiForce®EIZO CORPORATIONPGY2026-07-22
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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