DEVICE CLASS
Class II
REGULATION
21 CFR 892.1170
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES
Recent clearances
K252718GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 510k2026-04-20
K2510223D-Shaper Medical S.L · 510k2025-09-05
K242295BunkerHill Health · 510k2025-04-08
K243218Medimaps Group SA · 510k2025-01-17
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.