DEVICE CLASS
Class II
REGULATION
21 CFR 892.1720
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
21
510(K)/PMA CLEARANCES
510k: 21
0
RECALL ENTRIES
Recent clearances
K253058Shantou Institute of Ultrasonic Instruments Co., Ltd. · 510k2026-06-18
K260085DRGEM Corporation · 510k2026-05-14
K253185Carestream Health · 510k2026-03-11
K253244Poskom Co., Ltd. · 510k2026-02-23
K250976Poskom Co., Ltd. · 510k2025-12-19
K251710Solutions For Tomorrow AB · 510k2025-10-24
K243864Bontech Co., Ltd. · 510k2025-09-12
K251443DRGEM Corporation · 510k2025-08-22
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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