Identity
- Trade Name
- InsightRT Software Suite Server FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Model / Reference
- ISS100S FDA UDI
Identifiers
- Catalog Number
- ISS100S FDA UDI
- Primary DI / UDI-DI
- B244ISS100S0 FDA UDI
- 510(k) Number
- K151560 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
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
InsightRT Software Suite Server by Siris Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K151560 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siris Medical
Sources (1)
- FDA UDI f5163df1-0124-4dd6-a7ec-789be6afaabb 36 fields · synced May 30, 2026