FDA.reportPublic FDA data

BARCO

Primary DI
05415334044371
Brand
BARCO
Company
Barco NV
Model
MDPC-8127
Catalog number
K9301101A2X
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
05415334044371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334044371054153340443715415334044371

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
05415334058460BarcoNMS 22026-11-03
05415334059122BarcoMNA-420 ENC ANAK93033402026-11-03
05415334062573BarcoMNA-420 ENC ANAK9303340B2026-11-03
05415334062993BarcoMNA-420 ENC ANAK9303340X2026-11-03
05415334059405BarcoMNA-410 WPMK93516812026-10-12
05415334050037BarcoMDSC-8532K93530172026-10-01
05415334050068BarcoMDSC-8532K93530152026-10-01
05415334059139BarcoMCC-300K93513022026-09-21
05415334059924BarcoMCC-300K93513012026-09-21
05415334059931BarcoMCC-300K93513002026-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815477020686Aperio GT 180 DXLEICA BIOSYSTEMS IMAGING, INCPSY2026-10-22
04582389010734NanoZoomer S20MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
04582389011236NanoZoomer S540MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
04582389011267Agilent S540MD Slide Scanner SystemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
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
05415334044289BARCOBarco 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