• 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 system, x-ray, mobile
510(k) Number K191025
Device Name DRX-Revolution Mobile X-ray System
Applicant
Carestream Health Inc.
150 Verona Street
rochester,  NY  14608
Applicant Contact gina maiolo
Correspondent
Carestream Health Inc.
150 Verona Street
rochester,  NY  14608
Correspondent Contact gina maiolo
Regulation Number892.1720
Classification Product Code
IZL  
Date Received04/18/2019
Decision Date 05/17/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-