Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)— 510(k) K251004

Name: FDA 510(k) clearance K251004
Creator: U.S. Food and Drug Administration
Published: 2025-11-06

Substantially Equivalent

Hefei Chimed Intelligent Machine Co., Ltd.

FDA 510(k) clearance K251004 for Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M), Substantially Equivalent on 2025-11-06. Applicant: Hefei Chimed Intelligent Machine Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hefei Chimed Intelligent Machine Co., Ltd.
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2025-04-01
Decision date: 2025-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hefei, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OXO

view all

K253296 — Digital C-ARM with 3D2026-06-05
K252579 — Orthoscan TAU MVP Mini C-Arm System2026-01-14
K253269 — OEC One CFD2025-11-26
K250587 — Orthoscan TAU Mini C-Arm2025-07-02
K243452 — Orthoscan VERSA Mini C-Arm2025-01-14

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.