Identity
- Trade Name
- DynaCAD EUDAMEDFDA 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 5 EUDAMED300010314352 EUDAMED5 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
- Catalog Number
- 4598-016-98182, 3000-103-14352, 300011916421 FDA UDI
- Primary DI / UDI-DI
- 00884838094857 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM426SY 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
- Netherlands 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
DynaCAD by Philips DS North America LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0884838BM426SY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips DS North America LLC
- EUDAMED SRN
- US-MF-000035802
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 09be7a6c-488b-42f4-8531-573672d262d7 61 fields · synced Jun 19, 2026
- FDA UDI 4a1811c4-2b06-4db0-b708-a5ec56519951 34 fields · synced May 30, 2026