Identity
- Trade Name
- XVI FDA UDI
- Generic Name
- Radiation therapy digital imager FDA UDI
- Device Name
- XVI Cassette S10 FDA UDI
- Model / Reference
- 1526910 FDA UDI
- Description
- XVI Cassette S10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060191071109 FDA UDI
- 510(k) Number
- K131965 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation therapy digital imager 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation therapy digital imager
Xvi by Elekta Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiation therapy digital imager.
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- I2C (IBA Image Guided Therapy Console) — Ion Beam Applications SA · Class II
- I2C (IBA Image-Guided Therapy Console) — Ion Beam Applications SA · Class II
- I2C (IBA Image-Guided Therapy Console) — Ion Beam Applications SA · Class II
- I2C (IBA Image-Guided Therapy Console) — Ion Beam Applications SA · Class II
- I2C (IBA Image-Guided Therapy Console) — Ion Beam Applications SA · Class II
- On-Board Imager (OBI) — Varian Medical Systems, Inc · Class II
- I2C (IBA Image-Guided Therapy Console) — Ion Beam Applications SA · Class II
Cleared under the same submission
K131965 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
- Elekta Inc.
Sources (1)
- FDA UDI 55e7e725-b0b5-4ffe-9612-416e29a20219 35 fields · synced May 30, 2026