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3mensio Workstation
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 9.0Model 3mensio Workstation510(k) K250330
Identity
- Trade Name
- 3mensio Workstation EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 3mensio Workstation 9.0 EUDAMED
- Model / Reference
- 3mensio Workstation EUDAMED9.0 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304453778 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08056304453778 EUDAMED
- 510(k) Number
- K153736 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application 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
- 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
3mensio Workstation by Pie Medical Imaging B.v. — 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
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 | K250330 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K153736 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K120367 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304453778 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pie Medical Imaging B.V.
- EUDAMED SRN
- NL-MF-000001540
- FDA Applicant
- Pie Medical Imaging BV
Sources (3)
- EUDAMED 3df188c2-1dfd-471c-9d4a-9b3b858e264d 85 fields · synced Jun 19, 2026
- FDA UDI 9b29239a-ccc3-4458-b176-fb61dbf71aad 34 fields · synced May 29, 2026
- FDA 510(k) K250330 1 fields · synced May 18, 2026