FDA 510(k) Application Details - K230020

Device Classification Name

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510(K) Number K230020
Device Name BriefCase
Applicant Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv 6706703 IL
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Contact Amalia Schreier
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Regulation Number

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Classification Product Code QFM
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Date Received 01/03/2023
Decision Date 02/01/2023
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

FDA Source Information for K230020


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