Identity
- Trade Name
- Selenia Dimensions C-View Software FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan. FDA UDI
- Model / Reference
- C-View FDA UDI
- Description
- Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan. FDA UDI
Identifiers
- Catalog Number
- SW-03052 FDA UDI
- Primary DI / UDI-DI
- 15420045500020 FDA UDI
- PMA Number
- P080003 FDA UDI
- FDA Product Code
- OTE FDA UDI
- GMDN Term
- Basic diagnostic x-ray system application software 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic diagnostic x-ray system application software
Selenia Dimensions C-View Software by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 6a4529dd-4754-4556-a120-2a20b57360db 36 fields · synced Jun 8, 2026