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 K000987
Device Name VFSS IMAGER, MODEL SIS-300
Applicant
Lifecare Imaging Intl., Ltd.
8411 Pyott Rd.
Lake In The Hills,  IL  60102
Applicant Contact RICHARD A ADAMS
Correspondent
Lifecare Imaging Intl., Ltd.
8411 Pyott Rd.
Lake In The Hills,  IL  60102
Correspondent Contact RICHARD A ADAMS
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
OXO  
Date Received03/27/2000
Decision Date 06/01/2000
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
-
-