FDA.reportPublic FDA data

Barco

Primary DI
05415334001732
Brand
Barco
Company
Barco NV
Model
MDPC-8127
Catalog number
K9301100A
Device description
MDPC-8127
Published
2021-06-28
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
PZZDigital pathology display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZZDigital Pathology DisplayPathology2

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
05415334001732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334001732054153340017325415334001732

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
DM exempt
true
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
06970027820902BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027820940BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027821077BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027821084BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
05051663010467EprediaSHANDON DIAGNOSTICS LIMITEDPZZ2025-03-10
05415334033665BarcoBarco NVPZZ2021-07-05
05415334033603BarcoBarco NVPZZ2021-07-05