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 Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K063877
Device Name SYNGO LUNG CAD
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact MORTEZA MINAEE
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact MORTEZA MINAEE
Regulation Number892.2050
Classification Product Code
OEB  
Date Received10/12/2006
Decision Date 10/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-