FinScan F350 Dental Cone-beam Computed Tomography
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242805 FDA 510(k)
- FDA Product Code
- OAS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FinScan F350 is a dental cone-beam computed tomography (CBCT) system designed for high-resolution imaging of dental and maxillofacial structures. It provides three-dimensional volumetric data to support diagnostic, treatment planning, and surgical assessments in dentistry, including evaluations of teeth, jawbone, and surrounding anatomy.
This device is intended for use in dental clinics and oral surgery settings, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance and EU MDR compliance, with no third-party involvement. The system requires proper calibration and maintenance in a controlled environment, adhering to manufacturer guidelines for optimal performance and safety.
Frequently asked questions
What types of clinical settings is the FinScan F350 designed for and what are its primary applications?
The FinScan F350 is specifically designed for dental clinics and oral surgery settings. Its primary applications include high-resolution imaging of dental and maxillofacial structures, such as teeth, jawbone, and surrounding anatomy. This 3D volumetric data supports diagnostic evaluations, treatment planning, and surgical assessments in dentistry, ensuring precise assessments for procedures like implants, extractions, or orthodontic planning.
Is the FinScan F350 a single-use or reusable device, and what maintenance requirements should be followed?
The FinScan F350 is a reusable medical instrument. To ensure optimal performance and safety, it requires proper calibration and maintenance in a controlled environment, following the manufacturer’s guidelines. Regular upkeep is essential to maintain imaging accuracy and device reliability over time.
What regulatory pathways has the FinScan F350 followed, and how does this affect its use?
The FinScan F350 has obtained FDA 510(k) clearance and complies with EU MDR regulations. This means it has undergone evaluation to demonstrate substantial equivalence to existing devices in the U.S. and meets EU safety, performance, and regulatory requirements. Clinicians and buyers can rely on its compliance with these pathways for trusted use in dental and maxillofacial imaging.
Does the FinScan F350 require any special storage conditions, and how should it be handled?
The FinScan F350 is not explicitly described as requiring special sterility conditions since it is a reusable instrument. However, as a medical imaging device, it should be stored in a clean, dry, and controlled environment to protect it from dust, moisture, or physical damage. Adherence to manufacturer instructions for setup, calibration, and maintenance is critical to ensure consistent performance.
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 | K242805 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changzhou Finno Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K242805 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026