Genius Ai Detection

FDA UDI

Class III (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: GENIUS AI DETECTION FDA UDI
Generic Name: Stationary mammographic x-ray system, digital FDA UDI
Device Name: Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. FDA UDI
Model / Reference: GENIUS AI DETECTION SOFTWARE FDA UDI
Description: Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. FDA UDI

Identifiers

Catalog Number: ASY-15431 FDA UDI
Primary DI / UDI-DI: 15420045512474 FDA UDI
PMA Number: P080003 FDA UDI
FDA Product Code: OTE FDA UDI
GMDN Term: Stationary mammographic x-ray system, digital FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Stationary mammographic x-ray system, digital

Genius Ai Detection by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary mammographic x-ray system, digital.

Magnification table — FUJIFILM Corporation · Class II
Compression plate for axilla radiography — FUJIFILM Corporation · Class II
Senographe Pristina — GE MEDICAL SYSTEMS, INC. · Class II
GIOTTO IMAGE — IMS GIOTTO SPA · Class II
Slide stopper E — FUJIFILM Corporation · Class II
MAMMOBED — IMS GIOTTO SPA · Class II
Chest wall pad — FUJIFILM Corporation · Class II
Radiation Screen — GE MEDICAL SYSTEMS, INC. · Class I

Cleared under the same submission

P080003 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hologic, Inc.

Sources (1)

FDA UDI 9e9aa535-f885-4da8-b35b-5d205d952ffb 37 fields · synced May 30, 2026