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 System, X-Ray, Stationary
510(k) Number K190330
Device Name DRX-Evolution/Plus with Dual Energy
Applicant
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Applicant Contact Carolyn Wagner
Correspondent
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Correspondent Contact Carolyn Wagner
Regulation Number892.1680
Classification Product Code
KPR  
Date Received02/14/2019
Decision Date 11/04/2019
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
-
-