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 K201836
Device Name Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Medical Systems, USA
2441 Michelle Dr.
Tustin,  CA  90630
Correspondent Contact Orlando Tadeo
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/02/2020
Decision Date 01/12/2021
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
-
-