Identity
- Trade Name
- QA StereoChecker EUDAMEDStandard Imaging QA StereoChecker FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- QA Beam Analyzer EUDAMEDStandard Imaging QA StereoChecker is a daily machine quality assurance checks for the Cyberknife (Accuray, Sunnyvale CA). FDA UDI
- Model / Reference
- 91349 EUDAMEDFDA UDI
- Description
- Standard Imaging QA StereoChecker is a daily machine quality assurance checks for the Cyberknife (Accuray, Sunnyvale CA). FDA UDI
Identifiers
- Catalog Number
- 91349 FDA UDI
- Primary DI / UDI-DI
- 00850019946123 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946QACHECKER94 EUDAMED
- FDA Product Code
- LHO FDA UDI
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1940 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
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
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Accelerator system quality assurance device
Standard Imaging QA StereoChecker by Standard Imaging, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (2)
- FDA UDI 336e3d21-01b3-4450-a1b3-e09246b90512 34 fields · synced Jun 18, 2026
- EUDAMED 09002abf-cbce-4ad8-87fe-7b06c5dbae64 61 fields · synced Jun 18, 2026