Oscar 15 & Oscar 15i Interventional Fluoroscopic X-Ray System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230787 FDA 510(k)
- FDA Product Code
- OWB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Oscar 15 & Oscar 15i are classified as Interventional Fluoroscopic X-Ray Systems, designed for real-time imaging during minimally invasive procedures. These devices provide continuous X-ray visualization to guide interventions such as angiography, arthroscopy, or orthopedic surgeries, ensuring precision and reducing radiation exposure to patients and operators.
Supplied as a reusable medical device, the Oscar 15 & Oscar 15i is intended for use in radiology departments and surgical suites. It operates under FDA 510(k) clearance and MDR compliance, with MRI safety classifications noted in associated registration records. The systems are available in multiple configurations, as indicated by the listed FEI numbers, and require proper calibration, maintenance, and storage in accordance with manufacturer guidelines to ensure optimal performance and regulatory adherence.
Frequently asked questions
What types of medical procedures can the Oscar 15 & Oscar 15i be used for, and why is real-time imaging important in these settings?
The Oscar 15 & Oscar 15i are designed for real-time imaging during minimally invasive procedures such as angiography, arthroscopy, and orthopedic surgeries. Real-time imaging is critical in these settings because it allows clinicians to visualize internal structures continuously, ensuring precision during interventions like catheter placement, joint repairs, or vascular procedures. This reduces the risk of complications and minimizes radiation exposure to both patients and operators by enabling immediate adjustments and accurate guidance.
Are the Oscar 15 & Oscar 15i systems reusable, and what maintenance requirements should be followed to ensure proper functionality?
Yes, the Oscar 15 & Oscar 15i are supplied as reusable medical devices. To maintain optimal performance and comply with regulatory standards, they require regular calibration, maintenance, and storage as outlined by the manufacturer. Proper care ensures reliability, accuracy, and adherence to safety protocols in clinical environments.
How many different configurations or models are available for the Oscar 15 & Oscar 15i, and how can I identify the specific FEI number for my system?
The Oscar 15 & Oscar 15i are available in multiple configurations, each associated with a unique FEI (Facility Equipment Identifier) number. Over 80 distinct FEI numbers are listed in the regulatory records, such as 3002619595, 3005706667, and others. To identify your system’s specific FEI, check the device documentation or labeling provided by the manufacturer, as these numbers correspond to different technical or spatial setups of the system.
What regulatory pathways have the Oscar 15 & Oscar 15i followed, and how does this affect their use in clinical settings?
The Oscar 15 & Oscar 15i have undergone FDA 510(k) clearance and comply with the EU’s Medical Device Regulation (MDR). These pathways confirm that the systems meet established safety and performance standards for interventional fluoroscopic X-ray systems. Clinicians can rely on these regulatory approvals to ensure the devices are suitable for use in radiology departments and surgical suites, adhering to both national and international medical device compliance requirements.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230787 | Class II | Active |
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Manufacturer
- Manufacturer
- Genoray Co., Ltd.
Sources (2)
- FDA 510(k) K230787 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026