• 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 interventional fluoroscopic x-ray system
510(k) Number K142736
Device Name XIDF-AWS801, Angio Workstation, v5.31
Toshiba Medical Systems Corporation
1385 Shimoishigami
Otwara-chi,  JP 324-8550
Applicant Contact Paul Biggins
Toshiba America Medical Systems, Inc.
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Paul Biggins
Regulation Number892.1650
Classification Product Code
Subsequent Product Code
Date Received09/23/2014
Decision Date 03/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No