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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K262134
Device Name NeuroDR
Applicant
Deep Reasoning Ai, Inc.
1330 Main St., Unit 4
Sarasota,  FL  34236
Applicant Contact Jeanne Usonis
Correspondent
Innolitics, LLC
1101 W. 34th St. Suite 550
Austin,  TX  78705
Correspondent Contact Cooper Molloy
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/25/2026
Decision Date 10/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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