DEVICE CLASS
Class II
REGULATION
21 CFR 892.1200
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
19
510(K)/PMA CLEARANCES
510k: 19
0
RECALL ENTRIES
Recent clearances
K261315Siemens Medical Solutions USA, Inc. · 510k2026-05-21
K260524Shanghai United Imaging Healthcare Co., Ltd. · 510k2026-04-03
K253564Shanghai United Imaging Healthcare Co., Ltd. · 510k2026-02-13
K254001Spectrum Dynamics Medical, Ltd. · 510k2026-01-13
K253844Mediso Medical Imaging Systems, Ltd. · 510k2025-12-30
K251370Canon Medical Systems Corporation · 510k2025-12-01
K251401Trustees of the University of Pennsylvania · 510k2025-11-25
K252477Hermes Medical Solutions AB · 510k2025-09-09
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.
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