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Bot Image, Inc.

FDA UDI

Class II (US FDA UDI)

by Bot Image, Inc.

Identity

Trade Name
Bot Image, Inc. FDA UDI
Generic Name
MRI image interpretive software FDA UDI
Device Name
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted FDA UDI
Model / Reference
ProstatID™ FDA UDI
Description
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted FDA UDI

Identifiers

Catalog Number
580SW.01 FDA UDI
Primary DI / UDI-DI
00860009082618 FDA UDI
510(k) Number
K212783 FDA UDI
FDA Product Code
QDQ FDA UDI
GMDN Term
MRI image interpretive software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2090 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: MRI image interpretive software

Bot Image, Inc. by Bot Image, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI image interpretive software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bot Image, Inc.

Sources (1)

  • FDA UDI 55b189ee-bf1d-4508-a951-e10fd3e8dce6 35 fields · synced Jun 9, 2026