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, Applicator, Radionuclide, Remote-Controlled
510(k) Number K001825
Device Name STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
Applicant
Standard Imaging, Inc.
7601 Murphy Dr.
Middleton,  WI  53562
Applicant Contact RAYMOND RIDDLE
Correspondent
Standard Imaging, Inc.
7601 Murphy Dr.
Middleton,  WI  53562
Correspondent Contact RAYMOND RIDDLE
Regulation Number892.5700
Classification Product Code
JAQ  
Subsequent Product Code
IWJ  
Date Received06/16/2000
Decision Date 08/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-