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Segment CMR
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 07350010100027
by Medviso AB
Identity
- Trade Name
- Segment CMR EUDAMEDFDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- Segment CMR EUDAMEDSoftware for cardiac image analysis. FDA UDI
- Model / Reference
- 07350010100027 EUDAMED2 FDA UDI
- Description
- Software for cardiac image analysis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350010100027 EUDAMEDFDA UDI
- Basic UDI-DI
- 073500101000277G EUDAMEDB-07350010100027 EUDAMED
- Direct Marketing DI
- 07350010100027 EUDAMED
- 510(k) Number
- K163076 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z129092 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- MRI system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Sweden 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Segment CMR by Medviso AB — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 073500101000277G | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K163076 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 073500101000277G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medviso AB
- EUDAMED SRN
- SE-MF-000003217
Sources (4)
- EUDAMED 712c80fd-82fe-440b-8c65-f5e8e3ba0786 61 fields · synced Aug 4, 2026
- EUDAMED ca511cff-df08-4be6-a91b-af1d62f30160 61 fields · synced May 19, 2026
- FDA UDI 3f1b17cd-f331-4d61-846b-dc64063eb17e 34 fields · synced May 30, 2026
- FDA 510(k) K163076 1 fields · synced May 18, 2026