Identity
- Trade Name
- SecurView Diagnostic Workstation FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- The SecurView® DX diagnostic workstation software is an application that displays images on mammography review workstations for use by radiologists in the interpretation of images acquired from mammography and digital breast tomosynthesis. FDA UDI
- Model / Reference
- SecurView DX FDA UDI
- Description
- The SecurView® DX diagnostic workstation software is an application that displays images on mammography review workstations for use by radiologists in the interpretation of images acquired from mammography and digital breast tomosynthesis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15420045504523 FDA UDI
- 510(k) Number
- K103385 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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: Laboratory instrument/analyser application software IVD
SecurView Diagnostic Workstation by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f9ce9014-fdb2-4d56-b7bb-9cce449acb44 35 fields · synced May 30, 2026