ULTRASOUND AI INC.

FDA Device Registration & Listing · Highlands Ranch, CO, US · Registration 3044467584

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3044467584
FEI Number
3044467584
Entity Name
ULTRASOUND AI INC.
City/State/Country
Highlands Ranch, CO, US
Establishment Address
4349 Ivycrest Pt, Highlands Ranch, CO 80130, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ultrasound AI Inc. (Owner Number: 10095554)
Owner / Operator Contact Address
4349 Ivycrest Pt, Highlands Ranch, CO 80130, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN250007
PMA Number
N/A

All Registered Proprietary Names

Delivery Date AI

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SHE Radiological Software System For Delivery Date Prediction Radiology Class 2 892.8200 2026-03-29

Official Correspondent

Robert Bunn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ultrasound AI Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044467584. Last updated year: 2026. Please use registration number 3044467584 when referencing this establishment in official correspondence.
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