OSCAR (OSCAR Prime, OSCAR Classic)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181943 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 (OSCAR Prime, OSCAR Classic) is an Interventional Fluoroscopic X-Ray System, designed to generate real-time fluoroscopic and spot film imaging for diagnostic, surgical, and interventional procedures. It supports high-resolution visualization of internal structures during procedures such as cholangiography, endoscopy, and urologic interventions, enabling precise guidance and assessment.
This system is supplied as a mobile unit, intended for use in radiology departments, operating rooms, and interventional suites. It is classified as a Class II medical device under FDA regulation 892.1650 and has received FDA 510(k) clearance (K181943) as well as MDD and MDR authorisations. The device is non-sterile, reusable, and must be handled in accordance with radiation safety protocols. Multiple model variants are available, as indicated by the associated FEI numbers.
Frequently asked questions
What types of procedures can the OSCAR system support with its real-time imaging capabilities?
The OSCAR system is designed to provide high-resolution fluoroscopic and spot film imaging, making it suitable for procedures like cholangiography, endoscopy, and urologic interventions. Its real-time visualization helps guide and assess these procedures with precision in settings such as radiology departments, operating rooms, and interventional suites.
Is the OSCAR system mobile, and where is it typically used?
Yes, the OSCAR system is supplied as a mobile unit, allowing flexibility for use in various clinical environments. It is primarily intended for radiology departments, operating rooms, and interventional suites, where mobility and precise imaging are essential.
Are there multiple model variants of the OSCAR system, and how can I identify them?
Yes, the OSCAR system includes multiple model variants, specifically the OSCAR Prime and OSCAR Classic. These variants can be identified by their associated FEI (Facility Equipment Identifier) numbers, which include a long list of unique codes such as 3002619595, 3005706667, and others listed in the specifications.
How should the OSCAR system be handled in terms of radiation safety?
The OSCAR system is a non-sterile, reusable device that must be operated strictly in accordance with radiation safety protocols. Since it generates X-ray imaging, proper training and adherence to safety guidelines are critical to ensure safe and effective use.
What regulatory pathways has the OSCAR system undergone, and what does this mean for its use?
The OSCAR system has received FDA 510(k) clearance (K181943), indicating it is classified as substantially equivalent to a predicate device under FDA regulation 892.1650. It has also obtained MDD (Medical Device Directive) and MDR (Medical Device Regulation) authorizations, ensuring compliance with European standards. This regulatory clearance supports its use in clinical settings where such approvals are recognized.
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. Sources consulted: OSCAR (OSCAR Prime, OSCAR Classic) by Genoray Co., Ltd. | FDA 510 (k ..., OSCAR (OSCAR Prime, OSCAR Classic) 510(k) K181943 - FDA.report, K181943 FDA 510 (k) - OSCAR (OSCAR Prime | Genoray Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181943 | Class II | Active |
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Manufacturer
- Manufacturer
- Genoray Co., Ltd.
Sources (2)
- FDA 510(k) K181943 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026