Identity
- Trade Name
- Unifi Workspace FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Unifi® Software is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammmography images as well as other medical images and data. FDA UDI
- Model / Reference
- Unifi Workspace V1.0 FDA UDI
- Description
- Unifi® Software is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammmography images as well as other medical images and data. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15420045512634 FDA UDI
- 510(k) Number
- K190694 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Unifi Workspace by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 db854d77-1823-4e38-bf12-e440293fcc39 36 fields · synced May 31, 2026