Sectra-Imtec AB

Aubrey, TX, US

Sectra-Imtec AB appears in FDA device records in Aubrey, TX. FDA records list 14 510(k) clearances between 1996-08-13 and 2011-04-28, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 14
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 14 510(k) clearances for Sectra-Imtec AB between 1996 and 2011. The busiest year on record is 1996, with 2. The most recent is 2011, with 1.

Clearances by year, as a table

510(k) clearance decisions for Sectra-Imtec AB, by decision year
Year	Clearances
1996	2
1997	1
1998	1
2000	1
2002	1
2003	2
2004	1
2005	2
2006	1
2008	1
2011	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K110025	SECTRA MICRODOSE MAMMOGRAPHY	MUE	Substantially Equivalent	2011-04-28
K081469	SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2	LLZ	Substantially Equivalent	2008-06-12
K063093	SECTRA WORKSTATION, VERSION 11.1	LLZ	Substantially Equivalent	2006-11-07
K051315	MODIFICATION TO: SECTRA IDS5 WORKSTATION	LLZ	Substantially Equivalent	2005-06-15
K050196	SECTRA IDS5 WORKSTATION	LLZ	Substantially Equivalent	2005-02-24
K040376	SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE	LLZ	Substantially Equivalent	2004-05-04
K033712	MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1	LLZ	Substantially Equivalent	2003-12-23
K031590	SECTRA ORTHOPEDIC PACKAGE	LLZ	Substantially Equivalent	2003-10-02
K021527	SECTRA OSTEOPOROSIS PACKAGE	KGI	Substantially Equivalent	2002-06-07
K002936	MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM	LLZ	Substantially Equivalent	2000-10-17
K983447	WISE (II) IMAGE MANAGEMENT SYSTEM	LMB	Substantially Equivalent	1998-10-29
K965161	SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)	LMD	Substantially Equivalent	1997-03-12
K963395	IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM	LMB	Substantially Equivalent	1996-10-25
K961983	TRS 2000 TELERADIOLOGY SYSTEM	LLZ	Substantially Equivalent	1996-08-13

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Sectra-Imtec AB edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Sectra-Imtec AB. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain