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, X-Ray, Mammographic
510(k) Number K922454
Device Name MOBILE ATHENA HF
Applicant
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Applicant Contact JAMES W MORGAN
Correspondent
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Correspondent Contact JAMES W MORGAN
Regulation Number892.1710
Classification Product Code
IZH  
Date Received05/26/1992
Decision Date 09/11/1992
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
-
-