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Integrated Conical Collimator Verification and Interlock System (ICVI) Mount
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 10005269607510(k) K123788
Identity
- Trade Name
- Integrated Conical Collimator Verification and Interlock System (ICVI) Mount EUDAMED
- Device Name
- Integrated Conical Collimator Verification and Interlock System (ICVI) EUDAMED
- Model / Reference
- 10005269607 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00899475002684 EUDAMED
- Basic UDI-DI
- 089947500200112PF EUDAMED
- EMDN Code
- Z11010780 RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
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
Integrated Conical Collimator Verification and Interlock System (ICVI) Mount by Varian Medical Systems, Inc — Class IIb — FDA_510K, MDR — listed in EUDAMED…
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 | K123788 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200112PF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED b4b75dce-1c11-4f6c-a4b3-670520316962 85 fields · synced Jun 19, 2026
- FDA 510(k) K123788 1 fields · synced May 18, 2026