DEVICE CLASS
Class II
REGULATION
21 CFR 892.2050
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K260694Carl Zeiss Meditec, AG · 510k2026-07-17
K253893Topcon Healthcare Solutions EMEA Oy · 510k2026-06-04
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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