Olympus Imagemanager System Version 6.0 for Windows

FDA 510(k) K952888 · Olympus America, Inc.

Substantially Equivalent

510(k) numberK952888

Submission

Device name
Olympus Imagemanager System Version 6.0 for Windows
Applicant
Olympus America, Inc.
Melville, NY, US
Received
June 23, 1995
Decision date
September 18, 1995
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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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

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Questions and answers

When was Olympus Imagemanager System Version 6.0 for Windows cleared by the FDA?

Olympus Imagemanager System Version 6.0 for Windows (K952888) received a 510(k) decision of Substantially Equivalent on September 18, 1995, 87 days after the submission was received.

What is the product code of K952888?

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