Standard Imaging QA BeamChecker Plus
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- QA BeamChecker Plus EUDAMEDStandard Imaging QA BeamChecker Plus FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- QA Beam Analyzer EUDAMEDStandard Imaging QA BeamChecker Plus is a reliable and uncomplicated measurement instrument for daily quality assurance testing of linear accelerator, TomoTherapy Hi Art System, or other rotational delivery treatment machine output. FDA UDI
- Model / Reference
- 90501 EUDAMEDFDA UDI
- Description
- Standard Imaging QA BeamChecker Plus is a reliable and uncomplicated measurement instrument for daily quality assurance testing of linear accelerator, TomoTherapy Hi Art System, or other rotational delivery treatment machine output. FDA UDI
Identifiers
- Catalog Number
- 90501 FDA UDI
- Primary DI / UDI-DI
- 00850019946116 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 BeamChecker Plus 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.
- Qumulate — Varian Medical Systems, Inc · Class I
- Blue Phantom² — IBA Dosimetry GmbH · Class II
- Detector Holder — IBA Dosimetry GmbH · Class II
- StereoPHAN — Sun Nuclear Corporation · Class I
- Detector Holder — IBA Dosimetry GmbH · Class II
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (2)
- FDA UDI ba2b04b4-559c-4cdd-85dd-ab860a0eb9ac 34 fields · synced Jul 24, 2026
- EUDAMED 2facd1e9-85f6-4776-9be5-2a562e41ecab 61 fields · synced Jul 24, 2026