Imageserver 2000 Picture Archiving System

FDA 510(k) K963395 · Sectra-Imtec AB

Substantially Equivalent

510(k) numberK963395

Submission

Device name
Imageserver 2000 Picture Archiving System
Applicant
Sectra-Imtec AB
Plano, TX, US
Received
August 28, 1996
Decision date
October 25, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LMB – Device, Digital Image Storage, Radiological
Device class
Class I (low risk)
Regulation
21 CFR 892.2010
Specialty
Radiology

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

Other 510(k)s with product code LMB

510(k)DeviceApplicantDecision
K992131Samsung Raypax Long Term ArchiveLMB · Traditional Samsung Sds Co., Ltd.09/13/1999SE
K984405Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000LMB · Traditional Intracom Corp.02/08/1999SE
K983447Wise (II) Image Management SystemLMB · Special Sectra-Imtec AB10/29/1998SE
K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)LMB · Traditional Parameter Developments, Inc.04/03/1998SE
K973463Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, ArchiveLMB · Traditional O Tech, Inc.12/02/1997SE
K973413Id. Store (Release 2.0)LMB · Traditional I.S.G. Technologies, Inc.11/25/1997SE
K972380Kodak Digital Science (KDS) Medical Image and Information Library (Miil)LMB · Traditional Eastman Kodak Company09/11/1997SE
K971848TDK Medical Grade Cd-RLMB · Traditional Tdk Electronics Corporation of America08/15/1997SE
K971451Wise Image Management SystemLMB · Traditional O Tech, Inc.06/26/1997SE
K963936Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional Biosound, Inc.03/31/1997SE

More from Biosound, Inc.

510(k)DeviceDecision
K110025Sectra Microdose MammographyMUE · Traditional 04/28/2011SE
K081469Sectra Workstation, IDS7 Version 11.3, IDS5 Version 11.1 P2LLZ · Special 06/12/2008SE
K063093Sectra Workstation, Version 11.1LLZ · Special 11/07/2006SE
K051315Modification to: Sectra IDS5 WorkstationLLZ · Special 06/15/2005SE
K050196Sectra IDS5 WorkstationLLZ · Special 02/24/2005SE
K040376Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageLLZ · Special 05/04/2004SE
K033712Modification to Sectra IDS5 Radiology Workstation - Version 10.1LLZ · Special 12/23/2003SE
K031590Sectra Orthopedic PackageLLZ · Traditional 10/02/2003SE
K021527Sectra Osteoporosis PackageKGI · Special 06/07/2002SE
K002936Modification to IDS5 Image Display SystemLLZ · Special 10/17/2000SE

Questions and answers

When was Imageserver 2000 Picture Archiving System cleared by the FDA?

Imageserver 2000 Picture Archiving System (K963395) received a 510(k) decision of Substantially Equivalent on October 25, 1996, 58 days after the submission was received.

What is the product code of K963395?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.