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FDA PRODUCT CODE · CLASS II

OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile

Fluoroscopy of the human body.

DEVICE CLASS
Class II
REGULATION
21 CFR 892.1650
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K253296Allengers Medical Systems Limited · 510k2026-06-05
K252579Ziehm-Orthoscan, Inc. · 510k2026-01-14
K253269Ge Hualun Medical Systems Co. , Ltd. · 510k2025-11-26
K251004Hefei Chimed Intelligent Machine Co., Ltd. · 510k2025-11-06
K250587Ziehm-Orthoscan, Inc. · 510k2025-07-02
K243452Ziehm-Orthoscan, Inc. · 510k2025-01-14
K240828Ge Hualun Medical Systems Co. , Ltd. · 510k2024-12-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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