FDA 510(k) Application Details - K231162

Device Classification Name System, Image Processing, Radiological

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510(K) Number K231162
Device Name System, Image Processing, Radiological
Applicant Orthosoft, Inc (d/b/a Zimmer CAS)
75 Queen St., Suite 3300
Montreal H3C 2N6 CA
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Contact Victorien Thiaux
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 04/24/2023
Decision Date 05/23/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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