← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
IYN — System, Imaging, Pulsed Doppler, Ultrasonic
DEVICE CLASS
Class II
REGULATION
21 CFR 892.1550
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
101
510(K)/PMA CLEARANCES
510k: 101
0
RECALL ENTRIES
Recent clearances
K260667Philips Ultrasound, LLC · 510k2026-06-29
K260844Siemens Medical Solutions USA, Inc. · 510k2026-06-16
K260748E-Scopics · 510k2026-06-09
K260680Philips Ultrasound, LLC · 510k2026-05-27
K260123Philips Ultrasound, LLC · 510k2026-05-27
K260398GE Medical Systems Ultrasound and Primary Care Diagnostics · 510k2026-05-26
K253949CHISON Medical Technologies Co., Ltd. · 510k2026-05-22
K253720Wuhan United Imaging Healthcare Co.,Ltd · 510k2026-05-21
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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