Tomosynthesis option

FDA UDI

Class III (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name: Tomosynthesis option FDA UDI
Generic Name: Stationary mammographic x-ray system, digital FDA UDI
Device Name: Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography FDA UDI
Model / Reference: 11104944 FDA UDI
Description: Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography FDA UDI

Identifiers

Primary DI / UDI-DI: 04056869001005 FDA UDI
PMA Number: P140011 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Stationary mammographic x-ray system, digital

Tomosynthesis option by Siemens Healthcare — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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3Dimensions — Hologic, Inc. · Class III
Selenia Dimensions — Hologic, Inc. · Class II
Selenia Dimensions — Hologic, Inc. · Class II

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: Siemens Healthcare

Sources (1)

FDA UDI 8eb703a6-786b-464e-91f6-222b2930fbce 35 fields · synced May 30, 2026