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, Digital Image Communications, Radiological
510(k) Number K972366
Device Name IMNET DICOM NETWORK AGENT
Applicant
IMNET SYSTEMS, INC.
3015 WINDWARD PLAZA
WINDWARD FAIRWAYS II
ALPHARETTA,  GA  30202
Applicant Contact WI8LLIAM G BAIN
Correspondent
IMNET SYSTEMS, INC.
3015 WINDWARD PLAZA
WINDWARD FAIRWAYS II
ALPHARETTA,  GA  30202
Correspondent Contact WI8LLIAM G BAIN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received06/25/1997
Decision Date 09/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-