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, Angiographic
510(k) Number K052076
Device Name DAR-8000I
Applicant
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact RANDAL WALKER
Correspondent
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact RANDAL WALKER
Regulation Number892.1600
Classification Product Code
IZI  
Subsequent Product Code
LLZ  
Date Received08/01/2005
Decision Date 09/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-