Identity
- Trade Name
- Myrian EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Myrian EUDAMEDMyrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use. FDA UDI
- Model / Reference
- Myrian 2.9 EUDAMEDFDA UDI
- Description
- Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-MyrianHW EUDAMED03700719700471 FDA UDI
- Basic UDI-DI
- B-MyrianHW EUDAMED
- 510(k) Number
- K113620 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 EUDAMED
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tissue specimen x-ray system IVD
Myrian by Intrasense — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071000 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-MyrianHW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intrasense
- EUDAMED SRN
- FR-MF-000001551
Sources (3)
- EUDAMED 5ba44a11-2cc0-4450-b454-1df1011f3da2 61 fields · synced Aug 2, 2026
- FDA UDI ea597721-65af-4759-af2c-2c81b2ee997a 34 fields · synced May 30, 2026
- FDA 510(k) K071000 1 fields · synced May 18, 2026