Sectra AB

FDA Regulatory Profile

Sectra AB appears in FDA public data with 0 recalls, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 16, 2024.

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232208Sectra Digital Pathology Module (Version 3.3)April 16, 2024
K193054Sectra Digital Pathology ModuleMarch 31, 2020
K034059SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGEMarch 9, 2004
K033088SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1October 29, 2003
K001140IDS5 IMAGE DISPLAY SYSTEMMay 3, 2000