Identity
- Trade Name
- myQA iON EUDAMEDFDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- myQA iON EUDAMEDmyQA iON software FDA UDI
- Model / Reference
- MQ10-00X EUDAMEDMQ10-000 FDA UDI
- Description
- myQA iON software FDA UDI
Identifiers
- Primary DI / UDI-DI
- EIBAMQ100000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EIBAMYQAIONBX EUDAMED
- Direct Marketing DI
- EIBAMQ100000 EUDAMED
- 510(k) Number
- K201798 FDA UDI
- FDA Product Code
- IYE FDA UDILHN FDA UDI
- EMDN Code
- Z119002 DOSIMETERS 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
- Special Device Type
- Software EUDAMED
- 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
Yes
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
No
FDA UDI
myQA iON by IBA Dosimetry GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201798 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++EIBAMYQAIONBX | Class IIb | Active |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
- EUDAMED SRN
- DE-MF-000006225
Sources (3)
- EUDAMED 5ffb3c19-8285-4d3d-bafc-48bb8ff781f2 61 fields · synced Jun 19, 2026
- FDA UDI 21b7712d-2817-4cb0-8fd4-45b8e3d9200f 35 fields · synced May 30, 2026
- FDA 510(k) K201798 1 fields · synced May 18, 2026