• 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 Device, Digital Image Storage, Radiological
510(k) Number K973463
Device Name OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
Applicant
OTECH, INC.
6741 GRANT LN.
PLANO,  TX  75024
Applicant Contact HERMAN OOSTERWIJCK
Correspondent
OTECH, INC.
6741 GRANT LN.
PLANO,  TX  75024
Correspondent Contact HERMAN OOSTERWIJCK
Regulation Number892.2010
Classification Product Code
LMB  
Date Received09/12/1997
Decision Date 12/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-