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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K233331
Device Name MediOMx
Applicant
Pmx, Inc.
50 N Broadway St., Suite 3-3
Palatine,  IL  60067
Applicant Contact Girish Srinivasan
Correspondent
Cosm
45 Bartlett St.
San Francisco,  CA  94110
Correspondent Contact Rory Carrillo
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/29/2023
Decision Date 06/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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