FDA.reportPublic FDA data

Volpara Density Map

Primary DI
09421904268289
Brand
Volpara Density Map
Company
LUNIT INTERNATIONAL LIMITED
Model
3.4.2
Device description
Volpara Density Map 3.4.2
Published
2020-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153427000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153427000Volpara Imaging SoftwareMatakina Technology, Ltd.2016-01-07LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421904268289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421904268289094219042682899421904268289

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Regulatory Flags#

DUNS number
590762212
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421904268333Volpara Scorecard4.52025-05-06
09421904268340Volpara Live2.42025-05-06
09421904268241VolparaDensity4.02020-10-01
09421904268265VolparaDoseRT3.4.22020-09-24
09421904268272VolparaDoseSR3.4.22020-09-24
09421904268296VolparaDoseRT4.02020-09-24
09421904268302VolparaDoseSR4.02020-09-24
09421904268319Volpara Density Map4.02020-09-24
09421904268258VolparaDensity3.4.22020-08-26
09421904268050Volpara Density Map3.22016-04-22
09421904268098VolparaDensity3.32017-08-16
09421904268104VolparaDoseRT3.32017-08-16
09421904268128Volpara Density Map3.32017-08-16
09421904268166VolparaDensity3.4.12018-12-18
09421904268029VolparaDensity3.22016-04-22
09421904268036VolparaDoseRT3.22016-04-22
09421904268043VolparaDoseSR3.22016-04-22
09421904268074VolparaServer1.32016-04-22

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Primary DI, Brand, Company table
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G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
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08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
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08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25