Identity
- Trade Name
- 3DQuorum FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- 3DQuorum® is an image processing software application for post-processing tomosynthesis data captured on a Hologic tomosynthesis imaging system, into a combined 3D image. FDA UDI
- Model / Reference
- 3DQUORUM SOFTWARE FDA UDI
- Description
- 3DQuorum® is an image processing software application for post-processing tomosynthesis data captured on a Hologic tomosynthesis imaging system, into a combined 3D image. FDA UDI
Identifiers
- Catalog Number
- SW-05673 FDA UDI
- Primary DI / UDI-DI
- 15420045512313 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
3DQuorum by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stationary mammographic x-ray system, digital.
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- MAMMOBED — IMS GIOTTO SPA · Class II
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Cleared under the same submission
P080003 also covers:
- 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.
- 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 9091de70-7b47-420a-a6ae-22a7627a5c50 36 fields · synced May 29, 2026