Identity
- Trade Name
- HMS Medical Imaging Suite FDA UDI
- Generic Name
- Nuclear medicine system workstation FDA UDI
- Device Name
- HMS Medical Imaging Suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations. FDA UDI
- Model / Reference
- 5.7 FDA UDI
- Description
- HMS Medical Imaging Suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859873006059 FDA UDI
- FDA Product Code
- KPS FDA UDI
- GMDN Term
- Nuclear medicine system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HMS Medical Imaging Suite by Hermes Medical Solutions AB — 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
- Hermes Medical Solutions AB
Sources (1)
- FDA UDI 2924638f-b0e0-47bd-a90b-d2eb2df8ad9f 35 fields · synced Jun 1, 2026