FDA clearance and CE label
Elisa Renault
Ian Elliott
There may be others on this site more expert than me Elisa but it’s my understanding that only Osirix has FDA approval.
Ian
Ian Elliott
MRI Lead
Burgess Diagnostics Ltd.
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Les Trachtman
On Oct 26, 2021, at 5:54 AM, 'Ian Elliott' via Horos Project <horos-...@googlegroups.com> wrote:
There may be others on this site more expert than me Elisa but it’s my understanding that only Osirix has FDA approval.
LEGAL DISCLAIMERThe contents of this email and any transmitted files are confidential and intended solely for the use of the individual or entity to whom they are addressed. We hereby exclude any warranty and any liability as to the quality or accuracy of the contents of this email and any attached transmitted files. If you are not the intended recipient, be advised that you have received this email in error and that any use, dissemination, forwarding, printing or copying of the email is strictly prohibited. If you have received this email in error please contact the sender and delete the material from any computer. Burgess Diagnostics Ltd do not warrant that any attachments are free from viruses or other defects and accept no liability for any losses resulting from infected email transmissions.
In accordance with the new General Data Protection Regulation (GDPR) Burgess Diagnostics have published a new Privacy Document.To view please visit our website; www.burgessdiagnostics.com .For any further information regarding GDPR visit http://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/individual-rights/--
From: horos-...@googlegroups.com <horos-...@googlegroups.com> on behalf of Elisa Renault <b007...@essec.edu>
Date: Tuesday, 26 October 2021 at 10:05
To: Horos Project <horos-...@googlegroups.com>
Subject: FDA clearance and CE labelHello everyone,I would like to know if Horos Viewer is cleared by the FDA as a Medical Device for diagnostic imaging in medicine and/or complies with European Directive concerning medical devices (CE labeled) as his parent OsiriX.If not, is this something that is planned?Thank you very much,Elisa Renault--
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