DEVICE CLASS
Class II
REGULATION
21 CFR 892.2050
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
105
510(K)/PMA CLEARANCES
510k: 105
0
RECALL ENTRIES
Recent clearances
K262120Avara Software · 510k2026-07-10
K253899Provect.AI · 510k2026-07-09
K261465INDIGO TECHNOLOGIES · 510k2026-07-06
K260576MeVis Medical Solutions AG · 510k2026-06-30
K260231Apryse Software Corp · 510k2026-06-25
K253421Quantified Imaging Limited · 510k2026-06-22
K261352One Ortho · 510k2026-06-08
K260116CustoMED , Ltd. · 510k2026-06-03
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.