Identity
- Trade Name
- TomoScanner EUDAMEDStandard Imaging TomoScanner FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- QA Water Phantom (1D-2D) EUDAMEDStandard Imaging TomoScanner work together to provide QA scanning water tank measurements. FDA UDI
- Model / Reference
- 91750 EUDAMEDFDA UDI
- Description
- Standard Imaging TomoScanner work together to provide QA scanning water tank measurements. FDA UDI
Identifiers
- Catalog Number
- 91750 FDA UDI
- Primary DI / UDI-DI
- 00850019946499 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946WATERTANKU9 EUDAMED
- FDA Product Code
- LHO FDA UDI
- EMDN Code
- Z11019082 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Accelerator system quality assurance device
Standard Imaging TomoScanner by Standard Imaging, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Accelerator system quality assurance device.
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- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
- Vista — Modus Medical Devices Inc · Class I
- TomoDose — Sun Nuclear Corporation · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 5d067f24-7ce6-4902-8f89-68ca40ac5b94 34 fields · synced Jul 27, 2026
- EUDAMED e2390d2f-782f-45a7-8dcf-601a8621972f 61 fields · synced Jul 27, 2026