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 echo, ultrasonic
510(k) Number K132654
Device Name ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO
685 East Middlefield Road
Mountain View,  CA  94043
Applicant Contact PATRICK LYNCH
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN   OBJ  
Date Received08/26/2013
Decision Date 09/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-