FDA.reportPublic FDA data

Demetra

Primary DI
05415334036192
Brand
Demetra
Company
Barco NV
Model
Analytics Toolkit
Catalog number
K9302003B
Device description
non-invasive skin analysis system.
Published
2021-06-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSNLight based imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSNLight Based ImagingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201408000Demetra Analytics ToolkitBarco N.V.2021-02-18PSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415334036192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334036192054153340361925415334036192

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, digitalAn electrically-powered, hand-held instrument intended to be used for the microscopic examination of the external skin layers through the production of digital images (i.e. without direct optical view). The device has a built-in light source(s) and an electronic magnification system that provides the user with digital images of the structures of the epidermis and epidermal-dermal junction for visualization during dermatoscopy (also known as dermascopy). This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013961404DermoSight DermatoscopeDEEPX HEALTH, LLCPSN2025-06-19
00860013961411DermoSight SoftwareDEEPX HEALTH, LLCPSN2025-06-19
08602920003066VivaScope SystemCaliber Imaging & Diagnostics, Inc.PSN2023-02-16
05415334001763DemetraBarco NVPSN2020-06-04
00628451918035MoleMateMedX Health CorpPSN2016-09-22
00628451918004MoleMateMedX Health CorpPSN2016-09-22
00628451918073SIMSYSMedX Health CorpPSN2016-09-22
00860292000306VivaScope SystemCaliber Imaging & Diagnostics, Inc.PSN2016-08-22