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, Tomography, Computed
510(k) Number K152473
FOIA Releasable 510(k) K152473
Device Name CAS-One IR
Applicant
Cascination AG
Steigerhubelstrasse 3
Bern,  CH 3008
Applicant Contact Matthias Peterehans
Correspondent
Cascination AG
Steigerhubelstrasse 3
Bern,  CH 3008
Correspondent Contact Matthias Peterehans
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/31/2015
Decision Date 01/20/2016
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
-
-