DEVICE CLASS
Class II
REGULATION
21 CFR 892.1680
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
15
510(K)/PMA CLEARANCES
510k: 15
0
RECALL ENTRIES
Recent clearances
K260482Jpi Healthcare Co, Ltd. · 510k2026-06-15
K253446Dk Medical Systems Co., Ltd. · 510k2026-04-10
K250954Carestream Health · 510k2026-01-20
K252000Shanghai United Imaging Healthcare Co., Ltd. · 510k2025-11-26
K251167Shanghai United Imaging Healthcare Co., Ltd. · 510k2025-09-19
K250788Ge Hualun Medical Systems Co. , Ltd. · 510k2025-08-28
K250790Dk Medical Systems Co., Ltd. · 510k2025-08-01
K250738Siemens Medical Solutions · 510k2025-07-31
Related on SPEQ
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.