• 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 K192832
Device Name Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems Corporation
1385 Shimoishigami
otawara-shi,  JP 324-8550
Applicant Contact paul biggins
Canon Medical Systems USA
2441 Michelle Drive
tustin,  CA  92780
Correspondent Contact orlando tadeo
Regulation Number892.1750
Classification Product Code
Date Received10/02/2019
Decision Date 02/21/2020
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