Quantib Prostate

GUDID 08719689791056

Quantib B.V.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID08719689791056
NIH Device Record Key5356dd66-cf03-4f4b-84e4-c87872e8d895
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantib Prostate
Version Model Number1.0
Company DUNS490216247
Company NameQuantib B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108719689791056 [Primary]
GS108719689791056 [Primary]
GS108719689791056 [Primary]
GS108719689791056 [Primary]
GS108719689791056 [Primary]
GS108719689791056 [Primary]
GS108719689791056 [Primary]
GS108719689791056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

Devices Manufactured by Quantib B.V.

08719689791056 - Quantib Prostate2020-11-09
08719689791056 - Quantib Prostate2020-11-09
08719689791049 - Quantib AI Node2020-11-06
08719689791070 - Quantib Brain2020-10-14
08719689791032 - Quantib ND2020-05-11

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