FDA.reportPublic FDA data

BARCO

Primary DI
05415334044289
Brand
BARCO
Company
Barco NV
Model
MDPC-8127
Catalog number
K9301100A2X
Device description
MDPC-8127
Published
2023-12-19
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
PSYWhole Slide Imaging System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSYWhole Slide Imaging SystemPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203364000MDPC-8127Barco N.V.2021-04-15PSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415334044289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334044289054153340442895415334044289

GMDN Terms#

Term, Definition table
TermDefinition
Pathology information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of pathology services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

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
05415334053168BarcoMDSC-8532K93531112026-06-02
05415334053335BarcoMDSC-8532K93531212026-06-02
05415334056411BarcoMDSC-8527K93530121X2026-06-02
05415334056428BarcoMDSC-8532K93530131X2026-06-02
05415334056435BarcoMDSC-8527K93530181X2026-06-02
05415334056442BarcoMDSC-8532K93530191X2026-06-02
05415334061750BarcoMDNC-6121K9300360C2X2026-06-02
05415334057265Nio Color 8MPMDNC-8132K9300830B2X2026-05-07
05415334062412Nexxis ORNexxis systemK96104262026-04-28
05415334036277Nexxis ORNexxis systemK96104202021-06-28
05415334057258Eonis 32”MDRC-8132K9350830B2X2026-04-13
05415334050020BarcoMDSC-8532 K93530182025-12-22
05415334000148Nio 2MPE 2620 S2016-06-30
05415334050013BarcoMDSC-8532K93530192025-12-01
05415334053045Eonis 3DMDRC-8127K9301153A2X2025-12-01
05415334060159Nio 5.8MP GrayMDNG-6221K9300375C1X2025-12-01
05415334000155Barco Mammo TomosynthesisMDMG-52212016-06-30
05415334000162Coronis 3MP LEDMDCG-32212016-06-30
05415334000247Coronis Fusion 4MP LEDMDCC-4330K9301625A2016-06-30
05415334000261Coronis Fusion 6MP LEDMDCC-6430K9301635A2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336206737VENTANA DP 600 slide scannerRoche Diagnostics GmbHPSY2025-12-15
00884838124325Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-09-01
00884838124349Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-09-01
00860006054595Concentriq AP-DxProscia Inc.PSY2025-05-08
05415334055919BarcoBarco NVPSY2025-04-08
05415334055926BarcoBarco NVPSY2025-04-08
05415334056244BarcoBarco NVPSY2025-04-08
05415334056251BarcoBarco NVPSY2025-04-08
05051663010467EprediaSHANDON DIAGNOSTICS LIMITEDPSY2025-03-10
00884838121263Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-02-24
00860006054557Concentriq AP-Dx-US Proscia Inc.PSY2025-01-15
00884838121270Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-10-08
00860006054519Concentriq AP-DxProscia Inc.PSY2024-08-26
00884838092105Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-07-15
00815477020525Aperio GT 450 DX (US) ScannerLEICA BIOSYSTEMS IMAGING, INCPSY2024-05-31
05415334044371BARCOBarco NVPSY2023-12-19
00854904006039Synapse PathologyFujifilm Healthcare Americas CorporationPSY2023-06-16
04582389010659NanoZoomer S360MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2022-10-01
00815477020259Aperio AT2 DX ScannerLEICA BIOSYSTEMS IMAGING, INCPSY2020-01-23
00884838085640Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2017-12-15