Identity
- Trade Name
- WorkstationOne™ FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. FDA UDI
- Model / Reference
- 1.8.3 FDA UDI
- Description
- WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B148WSONE1830 FDA UDI
- 510(k) Number
- K073272 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology picture archiving and communication system workstation
WorkstationOne™ by Three Palm Software — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073272 also covers:
- NovaMG — Novarad Corporation
- NovaMG — Novarad Corporation
- WorkstationOne™ — Three Palm Software
- WorkstationOne™ — Three Palm Software
- WorkstationOne™ — Three Palm Software
- WorkstationOne™ — Three Palm Software
- WorkstationOne™ — Three Palm Software
- WorkstationOne™ — Three Palm Software
- WorkstationOne™ — Three Palm Software
- WorkstationOne™ — Three Palm Software
- WorkstationOne™ — Three Palm Software
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
- Three Palm Software
Sources (1)
- FDA UDI 9301a187-018c-42b4-959c-42a1223cf3a1 35 fields · synced Jun 9, 2026