Stradivarius™
FDA UDIEUDAMEDClass II (US FDA UDI)
by Qfix
Identity
- Trade Name
- Stradivarius™ FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Compression Paddle for Stradivarius SBRT System FDA UDI
- Model / Reference
- RT-4558KV4 EUDAMEDFDA UDISBRT Devices EUDAMED
- Description
- Compression Paddle for Stradivarius SBRT System FDA UDI
Identifiers
- Catalog Number
- RT-4558KV4 FDA UDI
- Primary DI / UDI-DI
- 00841962119689 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621SBRT8G EUDAMED
- 510(k) Number
- K171133 FDA UDI
- FDA Product Code
- IYE FDA UDIJAI FDA UDIJAK FDA UDIKPS FDA UDILHN FDA UDILNH FDA UDIOUO FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.5770 FDA UDI892.1750 FDA UDI892.1200 FDA UDI892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Indexed-immobilization patient positioning system
Stradivarius™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K171133 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Qfix
Sources (2)
- FDA UDI 0bb8b6f1-b225-4747-a605-194b79a1c77e 36 fields · synced Jun 18, 2026
- EUDAMED 58c50b31-a286-4360-b545-1d9db3d7b7ec 61 fields · synced Jun 18, 2026