Selenia Dimensions

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: Selenia Dimensions FDA UDI
Generic Name: Stationary mammographic x-ray system, digital FDA UDI
Device Name: Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort. FDA UDI
Model / Reference: ASY-01993 FDA UDI
Description: Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort. FDA UDI

Identifiers

Catalog Number: ASY-01993 FDA UDI
Primary DI / UDI-DI: 15420045507074 FDA UDI
PMA Number: P010025 FDA UDI
FDA Product Code: MUE FDA UDI
GMDN Term: Stationary mammographic x-ray system, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1715 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

Selenia Dimensions by Hologic, Inc. — Class II — 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

P010025 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 II	Pending data

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Manufacturer

Manufacturer: Hologic, Inc.

Sources (1)

FDA UDI cea6af60-617e-46ba-b25f-d74a1983a2ca 36 fields · synced Jun 8, 2026