| K-number | K252229 |
| Device name | BELLIGER ACE |
| Applicant | Genoray Co., Ltd. |
| Product code | OWB |
| Device class | Class II |
| Decision date | Apr 2, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1650 |
The BELLIGER ACE is a fluoroscopic X-ray system designed to provide real-time fluoroscopic and digital spot images during diagnostic, interventional, and surgical procedures. It consists of an X-ray tube, X-ray controller, and flat panel detector, and is used in healthcare facilities both inside and outside operating rooms.
The device has identical or similar X-ray generation characteristics to the predicate device (OSCAR Prime), including the same exposure modes, input voltage, tube voltage, tube current, and focal spot size. It uses the same detector type (OX/110-0514) and has an additional detector option (D-068SBR), both CMOS and a-Si TFT flat panel detectors. Minor design changes involve software and exterior modifications only.
Compliance with IEC 60601 series standards including IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020, IEC 60601-2-28:2017, IEC 60601-2-43:2022, and IEC 60601-2-54:2022 for safety and performance of X-ray equipment.
BELLIGER ACE is substantially equivalent to the predicate device because it has the same indications for use, identical X-ray generation and detector characteristics, similar output power and C-arm geometry, and clinical image evaluation confirmed that images are of acceptable quality and substantially equivalent to the predicate device, with no new safety or effectiveness questions raised.
View the full FDA submission: accessdata.fda.gov