Sony Laser Videodisc Recording System

FDA 510(k) K921275 · Sony Medical Systems

Substantially Equivalent

510(k) numberK921275

Submission

Device name
Sony Laser Videodisc Recording System
Applicant
Sony Medical Systems
Attleboro, MA, US
Received
March 20, 1992
Decision date
June 10, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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K992131Samsung Raypax Long Term ArchiveLMB · Traditional Samsung Sds Co., Ltd.09/13/1999SE
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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
K024188UP-DF500 Filmstation Digital Film ImagerLMC · Traditional 02/04/2003SE
K970999Sony PGM-100P1MD Trinitron Color Graphic MonitorJAK · Traditional 05/20/1997SE
K961680Sony DKR-700 Digital Still RecorderLMB · Traditional 07/03/1996SE
K931170Sony Cardiac Analysis and Review Station (Cars)IZI · Traditional 06/14/1993SE
K924708Cinenet Cardiac Image NetworkIZI · Traditional 12/30/1992SE

Questions and answers

When was Sony Laser Videodisc Recording System cleared by the FDA?

Sony Laser Videodisc Recording System (K921275) received a 510(k) decision of Substantially Equivalent on June 10, 1992, 82 days after the submission was received.

What is the product code of K921275?

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