Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sectra Imtec AB — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

29 daysmedian FDA review time

115 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K110025	SECTRA MICRODOSE MAMMOGRAPHY	Sectra Imtec AB	2011-04-28	115	0
K081469	SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2	Sectra Imtec AB	2008-06-12	16	0
K063093	SECTRA WORKSTATION, VERSION 11.1	Sectra Imtec AB	2006-11-07	28	1
K051315	MODIFICATION TO: SECTRA IDS5 WORKSTATION	Sectra Imtec AB	2005-06-15	26	1
K050196	SECTRA IDS5 WORKSTATION	Sectra Imtec AB	2005-02-24	28	0
K040376	SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTR	Sectra-Imtec AB	2004-05-04	77	0
K033712	MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION	Sectra-Imtec AB	2003-12-23	27	0
K031590	SECTRA ORTHOPEDIC PACKAGE	Sectra-Imtec AB	2003-10-02	134	0
K021527	SECTRA OSTEOPOROSIS PACKAGE	Sectra-Imtec AB	2002-06-07	28	0
K002936	MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM	Sectra-Imtec AB	2000-10-17	26	0
K983447	WISE (II) IMAGE MANAGEMENT SYSTEM	Sectra-Imtec AB	1998-10-29	29	3
K965161	SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)	Sectra-Imtec AB	1997-03-12	79	0
K963395	IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM	Sectra-Imtec AB	1996-10-25	58	0
K961983	TRS 2000 TELERADIOLOGY SYSTEM	Sectra-Imtec AB	1996-08-13	85	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda