Bot Image, Inc. 580SW.01

GUDID 00860009082618

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

Bot Image, Inc.

MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software MRI image interpretive software 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