Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023522713

FEI Number

3023522713

Entity Name

BOT IMAGE, INC.

City/State/Country

Omaha, NE, US

Establishment Address

14301 FNB Pkwy, Suite #109, Omaha, NE 68154, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BOT IMAGE, INC. (Owner Number: 10085779)

Owner / Operator Contact Address

20 Sunset Shores Drive, Belgrade, ME 04917, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212783

PMA Number

N/A

All Registered Proprietary Names

ProstatID

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2022-08-05

Official Correspondent

RANDALL JONES

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BOT IMAGE, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023522713. Last updated year: 2026. Please use registration number 3023522713 when referencing this establishment in official correspondence.