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Digisonics, Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2214-2023Class IIDigisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting softwareJune 26, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K970402DOCTORS REVIEW SYSTEMMarch 26, 1997
K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKApril 19, 1990
K800766ECHO-COMPApril 24, 1980