Identity
- Trade Name
- IQM Integral Quality Monitor EUDAMEDFDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- IQM Integral Quality Monitor EUDAMEDIQM is quality assurance device for medical linear accelerators for verifying the treatment beam. FDA UDI
- Model / Reference
- 1013 EUDAMED1013 (vers 1.3) FDA UDI
- Description
- IQM is quality assurance device for medical linear accelerators for verifying the treatment beam. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B50510130 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B505IQMQU EUDAMED
- 510(k) Number
- K162629 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany 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
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: Accelerator system quality assurance device
IQM Integral Quality Monitor by iRT Systems GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B505IQMQU | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- iRT Systems GmbH
- EUDAMED SRN
- DE-MF-000013778
Sources (2)
- EUDAMED e80ba8fc-326e-4a66-8ebe-729742094d55 61 fields · synced May 30, 2026
- FDA UDI e9d70b3f-ee77-4682-9399-078b0b79a78f 35 fields · synced May 30, 2026