Clinically approved?

[Sam Sahimi]

Hi Guys, 

I am an IT and worked with DCM4CHE a while back.  Is dcm4che clinically approved or approved by any governing body?

Also, is it approved to be installed on a Hyper-V?  

Many thanks guys!

Sam

[Dr Suresh Viswanathan]

dcm4che(e) is an open source project and isn’t certified by any body.

Hyper-V is a virtualisation platform for operating systems. dcm4chee is a J2EE application that runs at a higher layer (if you go the bare metal route) or is available as a Docker container. I don’t see why you need an "approval” for Hyper-V!

Suresh

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[Matthew Hill]

Product Classification (fda.gov)

510(K) Exempt Device Class 1 892.2010

PACS devices do not require FDA 501K as they are storage and communications devices.

New Search Back to Search Results Device Device, Digital Image Storage, Radiological Regulation Description Medical image storage device. Definition Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images. Regulation Medical Specialty Radiology Review Panel Radiology Product Code LMB Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR) Division of Radiological Health (DRH) Submission Type 510(K) Exempt Regulation Number 892.2010 Device Class 1 Total Product Life Cycle (TPLC) TPLC Product Code Report GMP Exempt? No Summary Malfunction Reporting Eligible     Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. Implanted Device? No Life-Sustain/Support Device? No Third Party Review Not Third Party Eligible

VIEWERS, however, at least in the US, are covered.

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