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 Digitizer, Image, Radiological
510(k) Number K973411
Device Name DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
Applicant
General Scanning, Inc.
500 Arsenal St.
Watertown,  MA  02172
Applicant Contact WALTER J LESLIE
Correspondent
General Scanning, Inc.
500 Arsenal St.
Watertown,  MA  02172
Correspondent Contact WALTER J LESLIE
Regulation Number892.2030
Classification Product Code
LMA  
Date Received09/09/1997
Decision Date 12/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-