Identity
- Trade Name
- 3Dimensions FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast. FDA UDI
- Model / Reference
- 3DM-SYS-INTL3D-MOB FDA UDI
- Description
- Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast. FDA UDI
Identifiers
- Catalog Number
- 3DM-SYS-INTL3D-MOB FDA UDI
- Primary DI / UDI-DI
- 15420045510562 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary mammographic x-ray system, digital
3Dimensions 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:
- 3DQuorum — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
- 3Dimensions — Hologic, Inc.
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
- Hologic, Inc.
Sources (1)
- FDA UDI a713dc4a-de70-4cf2-b3e1-e86ad857d4fc 36 fields · synced Jun 6, 2026