Accesspoint, Med E-Mail, Dicom Reader

FDA 510(k) K963936 · Biosound, Inc.

Substantially Equivalent

510(k) numberK963936

Submission

Device name
Accesspoint, Med E-Mail, Dicom Reader
Applicant
Biosound, Inc.
Indianapolis, IN, US
Received
October 1, 1996
Decision date
March 31, 1997
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
K964803Univision Echocardiology SystemLMB · Traditional Network Concepts, Inc.02/11/1997SE

More from Network Concepts, Inc.

510(k)DeviceDecision
K971700Biopsy Accessory for Ultrasound TransducerITX · Traditional 07/09/1997SE
K963262Artoscan MLNH · Traditional 03/28/1997SE
K963662Galileo Evoked PotentialreGWF · Traditional 02/26/1997SE
K953716Intracavity TransducersITX · Traditional 04/17/1996SE
K953530Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-AIYO · Traditional 04/08/1996SE
K953819Diagnostic Ultrasound TranducerITX · Traditional 03/01/1996SE
K953759Diagnostic Ultrasound TransducerITX · Traditional 03/01/1996SE
K955458Ultrasound Probe Biopsy AccessoriesITX · Traditional 02/12/1996SE
K953579Tee ProbeITX · Traditional 02/02/1996SE
K953430Ultrasound Probe Biopsy AccessoriesITX · Traditional 10/24/1995SE

Questions and answers

When was Accesspoint, Med E-Mail, Dicom Reader cleared by the FDA?

Accesspoint, Med E-Mail, Dicom Reader (K963936) received a 510(k) decision of Substantially Equivalent on March 31, 1997, 181 days after the submission was received.

What is the product code of K963936?

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