Bot Image, Inc.

GUDID 00860009082601

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform

Bot Image, Inc.

MRI image interpretive software
Primary Device ID00860009082601
NIH Device Record Keyefee4e08-eee5-4f90-98a7-6c45d97c0d98
Commercial Distribution StatusIn Commercial Distribution
Brand NameBot Image, Inc.
Version Model NumberProstatID™
Company DUNS117612526
Company NameBot Image, Inc.
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
GS100860009082601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-27
Device Publish Date2023-03-17

On-Brand Devices [Bot Image, Inc.]

00860009082618ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise
00860009082625ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
00860009082601ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform

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