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C-RAD POSITIONING AB

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1092-2026Class IIBrand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-00October 9, 2025
Z-1858-2025Class IIBrand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-00April 22, 2025
Z-2075-2021Class IIPC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 andAugust 6, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K200435Catalyst+, Catalyst+ HDMay 7, 2020
K200600SentinelApril 20, 2020
K120668SENTINELJuly 30, 2012
K113276CATALYSTFebruary 27, 2012
K082582SENTINEL, MODEL SP-001March 30, 2009
K063839POSITIONERFebruary 8, 2007