FDA.reportPublic FDA data

Quantib Prostate

Primary DI
08719689791056
Brand
Quantib Prostate
Company
Quantib B.V.
Model
1.0
Published
2020-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K202501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202501000Quantib ProstateQuantib B.V.2020-10-11LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719689791056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719689791056087196897910568719689791056

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
490216247
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719689791001Quantib ND1.52019-01-23
08719689791308Quantib AI Node2.82024-11-25
08719689791292Quantib Prostate3.32024-07-24
08719689791254Quantib Brain1.52024-03-20
08719689791278Quantib Prostate3.22023-12-14
08719689791285Quantib AI Node2.72023-12-14
08719689791261Quantib ND2.22023-06-22
08719689791230Quantib Prostate3.12023-05-11
08719689791223Quantib Prostate3.02023-05-10
08719689791247Quantib AI Node2.62023-02-23
08719689791209Quantib Prostate2.12022-08-26
08719689791216Quantib ND2.12022-06-21
08719689791193Quantib AI Node2.52022-06-16
08719689791186Quantib Prostate2.02022-05-17
08719689791179Quantib ND2.02022-02-04
08719689791162Quantib AI Node2.42021-11-08
08719689791155Quantib Prostate1.32021-10-13
08719689791124Quantib AI Node2.32021-04-13
08719689791131Quantib Prostate1.22021-04-13
08719689791148Quantib ND1.82021-04-13

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