FDA.reportPublic FDA data

VolparaDensity

Primary DI
09421904268241
Brand
VolparaDensity
Company
LUNIT INTERNATIONAL LIMITED
Model
4.0
Device description
Volpara Scorecard
Published
2020-10-01
Public version status
Update
Distribution status
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
09421904268241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421904268241094219042682419421904268241

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
09421904268265VolparaDoseRT3.4.22020-09-24
09421904268272VolparaDoseSR3.4.22020-09-24
09421904268289Volpara Density Map3.4.22020-09-24
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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