Identity
- Trade Name
- DynaCAD EUDAMEDInvivo FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- DynaCAD EUDAMEDDynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application. FDA UDI
- Model / Reference
- DynaCAD 4 EUDAMED784027 EUDAMED4.0 FDA UDI
- Description
- DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838086630 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838086630 EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11050182 MAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES 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
- 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
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
No
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
DynaCAD by Invivo Corporation — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192200 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K212175 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00884838086630 | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- Invivo Corporation
- EUDAMED SRN
- US-MF-000002284
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED 1f605184-44b3-46c5-85ed-d63b655cc393 61 fields · synced Jun 20, 2026
- FDA UDI 334a6045-78d4-4fb1-b30c-01f1f6c42dac 34 fields · synced May 30, 2026
- FDA 510(k) K192200 1 fields · synced May 18, 2026