DEVICE CLASS
Class II
REGULATION
21 CFR 892.1560
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
15
510(K)/PMA CLEARANCES
510k: 15
0
RECALL ENTRIES
Recent clearances
K260190ROPCA ApS · 510k2026-06-18
K252237Edgecare, Inc. · 510k2026-04-17
K254021Rivanna Medical, Inc. · 510k2026-04-09
K253898QT Imaging Holdings, Inc. · 510k2026-03-04
K253714Philips Image Guided Therapy Corporation · 510k2026-02-24
K253221Eieling Technology (Shenzhen) Limited · 510k2026-02-06
K250331Astrasono Technology Co., Ltd. · 510k2025-09-30
K250381DeepSight Technology, Inc. · 510k2025-08-01
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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