ASPIRE Cristalle Digital Breast Tomosynthesis Option

FDA UDI

Class III (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: ASPIRE Cristalle Digital Breast Tomosynthesis Option FDA UDI
Generic Name: Stationary mammographic x-ray system, digital FDA UDI
Device Name: The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images. FDA UDI
Model / Reference: DR 3500 TOMO KIT V2.0 USA E FDA UDI
Description: The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410351316 FDA UDI
PMA Number: P160031 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Stationary mammographic x-ray system, digital

ASPIRE Cristalle Digital Breast Tomosynthesis Option by FUJIFILM Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (1)

FDA UDI efd4190e-d1b0-4b15-96e3-1b21f91650b1 35 fields · synced Jun 8, 2026