Identity
- Trade Name
- 3Dimensions FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- Hologic Clarity HD® (high resolution tomosynthesis) is a software driven digital breast tomosynthesis 3(D) imaging feature intended to improve image resolution on tomosynhesis slices and synthesized 2D images that will enhance image quality and user experience. FDA UDI
- Model / Reference
- CLARITY HD SOFTWARE FDA UDI
- Description
- Hologic Clarity HD® (high resolution tomosynthesis) is a software driven digital breast tomosynthesis 3(D) imaging feature intended to improve image resolution on tomosynhesis slices and synthesized 2D images that will enhance image quality and user experience. FDA UDI
Identifiers
- Catalog Number
- SW-04756 FDA UDI
- Primary DI / UDI-DI
- 15420045507272 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
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
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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 c1ddc7ba-dd8b-4825-be66-173902fbab12 36 fields · synced Jun 8, 2026