Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

FDA Regulatory Profile

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2254-2021, Class II) was initiated on June 4, 2021.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2254-2021Class IISimpleware ScanIP medical software. For transfer of imaging information from a medical scanner to aJune 4, 2021
Z-2253-2021Class IISimpleware ScanIP software. For transfer of imaging information from a medical scanner to an output June 4, 2021