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Virtual Nodule Clinic
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref Virtual Nodule Clinic510(k) K202300
by Optellum Ltd
Identity
- Device Name
- Virtual Nodule Clinic EUDAMED
- Model / Reference
- Virtual Nodule Clinic EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B816VNC3P00 EUDAMED
- Basic UDI-DI
- ++B816VNC2P0YT EUDAMED
- Direct Marketing DI
- +B816VNC3P00 EUDAMED
- 510(k) Number
- K202300 FDA 510(k)
- FDA Product Code
- POK FDA 510(k)
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2060 FDA 510(k)
- Regulation Number
- 892.2060 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Full-body CT system
Virtual Nodule Clinic by Optellum Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202300 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++B816VNC2P0YT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Optellum Ltd
- EUDAMED SRN
- GB-MF-000002862
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3815c871-7058-4f1e-9d3f-6a4594b22dd3 61 fields · synced Jul 30, 2026
- FDA 510(k) K202300 24 fields · synced May 18, 2026