DEVICE CLASS
Class II
REGULATION
21 CFR 892.1750
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
46
510(K)/PMA CLEARANCES
510k: 46
0
RECALL ENTRIES
Recent clearances
K253560Ge Medical Systems, LLC · 510k2026-06-24
K253026Varian Medical Systems, Inc. · 510k2026-06-04
K253596Canon Medical Systems Corporation · 510k2026-05-20
K253649Philips Medical Systems Technologies , Ltd. · 510k2026-03-27
K252992Philips Healthcare (Suzhou) Co., Ltd. · 510k2026-03-23
K253686Ge Healthcare Japan Corporation · 510k2026-03-23
K253520Ge Medical Systems, LLC · 510k2026-03-20
K253574Siemens Medical Solutions USA, Inc. · 510k2026-03-20
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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