BELLIGER ACE— 510(k) K252229
Substantially EquivalentGenoray Co., Ltd.
FDA 510(k) clearance K252229 for BELLIGER ACE, Substantially Equivalent on 2026-04-02. Applicant: Genoray Co., Ltd.. Device class: 2.
Summary
Genoray's BELLIGER ACE is filed under product code OWB (Interventional Fluoroscopic X-Ray System). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Genoray filed from Seongnam-Si (the record lists the country as CN). The record shows 260 calendar days from receipt to decision (July 16, 2025 to April 2, 2026).
Clearance details
- Applicant
- Genoray Co., Ltd.
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seongnam-Si, CN
Recent devices under product code OWB
view allMore clearances from Genoray Co., Ltd.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.