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 Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K231709
Device Name AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
Applicant
Radmedix LLC
2510 Lance Dr
Dayton,  OH  45409
Applicant Contact Gabriel Issa
Correspondent
Kamm & Associates
8870 Ravello Ct
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received06/12/2023
Decision Date 07/12/2023
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
-
-