Nicom Digital Image Manager

FDA 510(k) K945654 · Camtronics, Ltd.

Substantially Equivalent

510(k) numberK945654

Submission

Device name
Nicom Digital Image Manager
Applicant
Camtronics, Ltd.
Hartland, WI, US
Received
November 17, 1994
Decision date
February 17, 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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More from Biosound, Inc.

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K992259Echocardiography System Series 95000LLZ · Traditional 09/08/1999SE
K990066CCD Camera, Model 9000LMA · Traditional 03/17/1999SE
K955519Analytical Review StationIZI · Traditional 05/09/1996SE
K954159Digital Imaging SystemLLZ · Traditional 03/19/1996SE
K955232NT Series Digital Image ManagerLMB · Traditional 12/11/1995SE
K953080Digital Imaging System InterfaceLMD · Traditional 09/28/1995SE
K941979Video Plus with Analytical WorkstationIZI · Traditional 08/17/1994SE

Questions and answers

When was Nicom Digital Image Manager cleared by the FDA?

Nicom Digital Image Manager (K945654) received a 510(k) decision of Substantially Equivalent on February 17, 1995, 92 days after the submission was received.

What is the product code of K945654?

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