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, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K241582
Device Name Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Medical Systems USA, Inc.
2441 Michelle Dr
Tustin,  CA  92780
Correspondent Contact Yoshiaki Cook
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received06/03/2024
Decision Date 09/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-