DEVICE CLASS
Class II
REGULATION
21 CFR 892.1000
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
14
510(K)/PMA CLEARANCES
510k: 14
0
RECALL ENTRIES
Recent clearances
K260947Neocoil, LLC · 510k2026-04-23
K252587Shenzhen RF Tech Co., Ltd. · 510k2026-04-14
K252876Shenzhen RF Tech Co., Ltd. · 510k2026-04-01
K260519Philips Healthcare (Suzhou) Co., Ltd. · 510k2026-03-20
K252179Shenzhen RF Tech Co., Ltd. · 510k2026-02-10
K253738Ge Healthcare Coils (Usa Instruments, Inc.) · 510k2026-01-23
K254190Philips Medical Systems Nederland B.V. · 510k2026-01-14
K253182Inkspace Imaging, Inc. · 510k2025-10-20
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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