X-Ray TV System SonialVision G4
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- X-RAY TV SYSTEM SONIALVISION G4 EUDAMEDSONIALVISION G4 EUDAMED
- Device Name
- X-RAY TV SYSTEM SONIALVISION G4 EUDAMED
- Model / Reference
- X-RAY TV SYSTEM SONIALVISION G4 EUDAMED566-10000-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217041114 EUDAMED
- Basic UDI-DI
- 45402170100000000000001SL EUDAMEDB-04540217041114 EUDAMED
- EMDN Code
- Z11030702 DIGITAL REMOTE CONTROL TABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The X-Ray TV System SonialVision G4 is a fluoroscopic imaging system classified under nomenclature code Z11030702, designed for real-time radiographic visualization. It provides high-resolution imaging for diagnostic and interventional procedures, enhancing clinical decision-making through clear, dynamic visualisation of internal structures.
This system is non-sterile, non-reusable, and intended for single-use applications in radiology settings. Supplied with reference code 566-10000-12, it operates under FDA 510K clearance, MDD, and MDR compliance. The device is not implantable, MRI-safe considerations are unspecified, and its active status confirms functionality for clinical use as intended by regulatory submissions.
Frequently asked questions
What is the primary use of the X-Ray TV System SonialVision G4 in clinical settings?
The X-Ray TV System SonialVision G4 is designed for real-time radiographic visualization during diagnostic and interventional procedures. Its high-resolution imaging helps clinicians visualize internal structures dynamically, supporting better decision-making in radiology environments.
Is the X-Ray TV System SonialVision G4 intended for reuse or single-use, and how is it supplied?
The device is explicitly intended for single-use only and is non-reusable. It is supplied with the reference code 566-10000-12, meaning each unit is meant to be used once before disposal.
How should the X-Ray TV System SonialVision G4 be stored, and is it sterile?
The system is non-sterile, so it does not require sterile storage conditions. However, proper handling and storage in a clean, dry environment are recommended to maintain functionality, as it is intended for single-use in controlled radiology settings.
What regulatory pathways does the X-Ray TV System SonialVision G4 follow, and who manufactures it?
The device follows FDA 510K clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance pathways. It is manufactured by Shimadzu Corporation (Japan) and distributed in Europe through Shimadzu Europa GmbH (Germany).
Does the X-Ray TV System SonialVision G4 have any size or model variations, or is it a single unified system?
The data provided indicates a single device model: the X-Ray TV System SonialVision G4, with no mention of size variations or multiple configurations. It is classified under nomenclature code Z11030702 as a unified fluoroscopic imaging system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/MDR
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190373 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K131075 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K142341 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 45402170100000000000001SL | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 45402170100000000000001SL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED 020d4f0d-1302-40b9-8995-f3f575c74a80 85 fields · synced Sep 18, 2026
- EUDAMED 13403e79-a7c1-43c6-a0ff-0b4b11e9c310 61 fields · synced May 16, 2026
- FDA 510(k) K190373 1 fields · synced May 18, 2026