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 K953942
Device Name COBRASCAN CX-312
Applicant
RADIOGRAPHIC DIGITAL IMAGING, INC.
1215 SOUTH ALAMEDA ST.
COMPTON,  CA  90220
Applicant Contact STEPHEN NEUSHUL
Correspondent
RADIOGRAPHIC DIGITAL IMAGING, INC.
1215 SOUTH ALAMEDA ST.
COMPTON,  CA  90220
Correspondent Contact STEPHEN NEUSHUL
Regulation Number892.2030
Classification Product Code
LMA  
Date Received08/03/1995
Decision Date 12/22/1995
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
-
-