Changzhou Finno Medical Technology Co., Ltd. · Class II · Cleared Jan 9, 2025
| K-number | K242805 |
| Device name | Dental Cone-beam Computed Tomography (FinScan F350) |
| Applicant | Changzhou Finno Medical Technology Co., Ltd. |
| Product code | OAS |
| Device class | Class II |
| Decision date | Jan 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1750 |
The FinScan F350 is a dental cone-beam computed tomography (CBCT) system that produces three-dimensional images of the dento-maxillofacial and temporomandibular joint (TMJ) structures for diagnostic support in adult and pediatric patients. It also performs panoramic and cephalometric radiography, including wrist/carpus imaging for growth assessment in orthodontic treatment, and is intended for use by dentists and qualified dental professionals.
The FinScan F350 uses CBCT technology with TFT detectors for CT and panoramic imaging and CMOS detectors for cephalometric scanning. It operates at 60–100 kVp with 6–10 mA tube current, provides scan times of 18 seconds (general) or 9 seconds (fast) for CBCT, and produces DICOM 3.0-compatible images. The device incorporates workstation-based image processing software and embedded firmware for motion control, with specifications including a 160×100 mm field of view and 100 μm detector pixel size.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-6, IEC 61223-3-4, IEC 61223-3-7, IEC 60825-1:2014, ISO 10993-1:2018, and 21 CFR Parts 1020.30, 1020.31, and 1020.33. Biocompatibility testing included cytotoxicity, irritation, and sensitization studies.
The FinScan F350 is substantially equivalent to the RCT700 predicate device because both employ identical CBCT cone-beam technology for the same dento-maxillofacial diagnostic applications and share substantially similar technological characteristics, including equivalent X-ray tube voltage/current ranges, detector types, DICOM format compatibility, and applicable electrical safety/EMC standards. Minor differences in display type, detector pixel sizes, scan times, and image viewing software do not raise new safety or effectiveness concerns, as demonstrated by bench testing confirming equivalent image quality metrics (spatial resolution, contrast-to-noise ratio, homogeneity) and clinical evaluation confirming acceptable diagnostic image quality for the intended indications.
View the full FDA submission: accessdata.fda.gov