Company · US

Sectra AB

FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2024. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
LLZ	System, Image Processing, Radiological	3
PSY	Whole Slide Imaging System	1
QKQ	Digital Pathology Image Viewing And Management Software	1

Decided	510(k)	Device and applicant	Code
Apr 16, 2024	K232208	Sectra Digital Pathology Module (Version 3.3) Sectra AB, SE	PSY
Mar 31, 2020	K193054	Sectra Digital Pathology Module Sectra AB, SE	QKQ
Mar 9, 2004	K034059	SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE Sectra AB	LLZ
Oct 29, 2003	K033088	SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 Sectra AB	LLZ
May 3, 2000	K001140	IDS5 IMAGE DISPLAY SYSTEM Sectra AB	LLZ

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.