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 Accelerator, Linear, Medical
510(k) Number K192196
Device Name Medical Radiation Dosimetry System microSTARii
Applicant
Landauer
2 Science Rd.
Glenwood,  IL  60425
Applicant Contact Matt Ennis
Correspondent
Landauer
2 Science Rd.
Glenwood,  IL  60425
Correspondent Contact Matt Ennis
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/13/2019
Decision Date 12/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-