I saw on 4DX's announcement on the 31st Oct they mentioned the date they submitted their 510(k) form to FDA for approval of CT LVAS.
"4DMedical’s 510(k) application for the CT LVAS™ imaging capability was submitted to the FDA on 9 August
and officially accepted for review shortly thereafter, with no requests for clarification received. The
Company is confident of a successful outcome from this detailed submission in the coming months."
I looked up how long a 510(k) form took to get approval and I found the following... So if the below info hasn't changed, approval is due any day.
Thoughts?
https://www.emergobyul.com/news/how-long-fda-review-process-510k-medical-device-submissions
Research, page-2113
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