Identity
- Trade Name
- Odyssey FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be exported in DICOM formats to administer treatments after review and approval by the intended user. FDA UDI
- Model / Reference
- 5.2.00 FDA UDI
- Description
- Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be exported in DICOM formats to administer treatments after review and approval by the intended user. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B211ODY520005 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
- 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
No
FDA UDI
Category: Radiation therapy software
Odyssey by Permedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Permedics, Inc.
Sources (1)
- FDA UDI cd196917-eb30-4440-94d7-a2d23cc10159 34 fields · synced Jun 8, 2026