Identity
- Trade Name
- RamSoft FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data. FDA UDI
- Model / Reference
- 6.0.11.11031B FDA UDI
- Description
- Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data. FDA UDI
Identifiers
- Catalog Number
- PSGWY6PRU11B FDA UDI
- Primary DI / UDI-DI
- B359PSGWY6PRU11B0 FDA UDI
- 510(k) Number
- K052460 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
- 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological PACS softwareRadiology picture archiving and communication system workstation
RamSoft by Ramsoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052460 also covers:
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
- Ramsoft Inc
Sources (1)
- FDA UDI 51f2e405-111d-47ba-bea1-255272ef378b 35 fields · synced Jun 8, 2026