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, Fluoroscopic, Image-Intensified
510(k) Number K111292
Device Name LUMINOS AGILE
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Applicant Contact PATRICIA D JONES
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Correspondent Contact PATRICIA D JONES
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
IZI  
Date Received05/06/2011
Decision Date 06/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-