Bot Image, Inc. 580SW.01

GUDID 00860009082618

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise

Bot Image, Inc.

MRI image interpretive software

• Primary Device ID: 00860009082618
• NIH Device Record Key: 55b189ee-bf1d-4508-a951-e10fd3e8dce6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bot Image, Inc.
• Version Model Number: ProstatID™
• Catalog Number: 580SW.01
• Company DUNS: 117612526
• Company Name: Bot Image, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009082618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212783

FDA Product Code

• QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-13
• Device Publish Date: 2023-01-11

On-Brand Devices [Bot Image, Inc.]

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