• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K992660
Device Name URF DIGITAL - OT
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin,  NJ  08830
Applicant Contact malgorzata stanek
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin,  NJ  08830
Correspodent Contact malgorzata stanek
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received08/09/1999
Decision Date 11/05/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-