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 Transducer, Ultrasonic, Diagnostic
510(k) Number K103645
Device Name APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Toshiba Medical Systems Corporation, Japan
2441 Michelle Dr.
Tustin,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
Toshiba Medical Systems Corporation, Japan
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Codes
DQK   IYN   IYO  
Date Received12/13/2010
Decision Date 01/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-