Identity
- Trade Name
- LungVision EUDAMEDLungVision System FDA UDI
- Generic Name
- Virtual bronchoscopic navigation PACS software FDA UDI
- Device Name
- LungVision System EUDAMEDThe LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. The mobile system cart is an optional unit to place the LUNGVISIONTM Main Unit and router, also used for storing all the system components: LV Board, Tablet, DVD reader, Keyboard, Mouse and cables. FDA UDI
- Model / Reference
- CORE EUDAMEDFDA UDILV1055002 EUDAMED
- Description
- The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. The mobile system cart is an optional unit to place the LUNGVISIONTM Main Unit and router, also used for storing all the system components: LV Board, Tablet, DVD reader, Keyboard, Mouse and cables. FDA UDI
Identifiers
- Catalog Number
- LV1055002 FDA UDI
- Primary DI / UDI-DI
- 07290017652085 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290017652BVMSYSTEM22 EUDAMED
- Direct Marketing DI
- 07290017652085 EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z119007 IMAGE ACQUISITION MODULES EUDAMED
- GMDN Term
- Virtual bronchoscopic navigation PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
LungVision by Body Vision Medical — 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 | 7290017652BVMSYSTEM22 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Body Vision Medical
- EUDAMED SRN
- IL-MF-000021610
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED f9988c93-c4ad-4094-aa8e-a1474ef66bc9 61 fields · synced Jul 19, 2026
- FDA UDI bf4bbb45-b783-4b57-a1b8-8173aac4fa13 34 fields · synced May 30, 2026