Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615992

FEI Number

3001104292

Entity Name

SECTRA AB

City/State/Country

LINKOPING Ostergotland, SE

Establishment Address

TEKNIKRINGEN 20, LINKOPING Ostergotland 58330, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SECTRA AB (Owner Number: 9026103)

Owner / Operator Contact Address

TEKNIKRINGEN 20, --, LINKOPING, SE-NOTA 58330, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sectra Digital Pathology Module Sectra Workstation IDS7 Sectra Workstation IDS5 Sectra Workstation Sectra Workstation UniView Sectra Orthopedic Package Sectra Calibration Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKQ	Digital Pathology Image Viewing And Management Software	Pathology	Class 2	864.3700	2020-04-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-06-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-12-17
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2010-05-03

Official Correspondent

Edoardo Mastrovito

US Agent Details

Edoardo Mastrovito Business: Sectra Inc. Email: regulatoryaffairs@sectra.com Phone: (203) 9250899

Related Public Records

Same Entity

SECTRA AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3008491142	FUJIFILM Healthcare Americas Corporation	Lexington, MA, US
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB
3006791373	Leica Biosystems Imaging, Inc.	Vista, CA, US
3039498387	PATHPRESENTER CORP	Montville, NJ, US
3031081536	INDICA LABS LLC	Albuquerque, NM, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615992. Last updated year: 2026. Please use registration number 9615992 when referencing this establishment in official correspondence.