Identity
- Trade Name
- DynaCAD Lung FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- DynaCAD Lung EUDAMED2.4.0.229939, Release date: 2021-09-03 2.4.1.252491, Release date: 2022-03-25 FDA UDI
- Model / Reference
- 2.4.x EUDAMEDDCL-2.4.x EUDAMED2.4 FDA UDI
- Description
- 2.4.0.229939, Release date: 2021-09-03 2.4.1.252491, Release date: 2022-03-25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260483290183 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260483290183 EUDAMED
- 510(k) Number
- K201501 FDA UDI
- FDA Product Code
- OEB FDA UDILLZ FDA UDI
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - 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
- 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Full-body CT system
DynaCAD Lung by Mevis Medical Solutions Ag — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260483290183 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MeVis Medical Solutions AG
- EUDAMED SRN
- DE-MF-000005418
Sources (2)
- EUDAMED 06e12e24-336b-469f-8765-bcc8d86e2028 61 fields · synced Aug 2, 2026
- FDA UDI 2f8c272a-d8b0-4448-90b8-9f47e52f1186 34 fields · synced May 29, 2026