Digital Disk Recorder

FDA 510(k) K933115 · Eigen

Substantially Equivalent

510(k) numberK933115

Submission

Device name
Digital Disk Recorder
Applicant
Eigen
Nevada City, CA, US
Received
June 25, 1993
Decision date
April 7, 1994
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.

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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

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K0810933-D Imaging WorkstationLLZ · Traditional 05/01/2008SE
K063846Eigen Dsa 2000LLZ · Special 01/26/2007SE
K924164Digital Disk Recorder W/Dualpath ARCHIVE/30-60 OptJAA · Traditional 11/23/1992SE
K923585Digital Fluoro StoreJAA · Traditional 10/21/1992SE
K913012Digital Fluoro Store(Dfs) W/Numerical SuffixesJAA · Traditional 09/23/1991SE
K905111Digital Disk Recorder(Ddr) W/Numerical SuffixesJAA · Traditional 01/25/1991SE

Questions and answers

When was Digital Disk Recorder cleared by the FDA?

Digital Disk Recorder (K933115) received a 510(k) decision of Substantially Equivalent on April 7, 1994, 286 days after the submission was received.

What is the product code of K933115?

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