Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K261997
Device Name NeuroAlign
Applicant
Medivis, Inc.
174 5th Ave.
Suite 200
New York,  NY  10010
Applicant Contact Amy Lynn
Correspondent
Medivis, Inc.
174 5th Ave.
Suite 200
New York,  NY  10010
Correspondent Contact Amy Lynn
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/15/2026
Decision Date 10/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-