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 Phantom, Anthropomorphic, Radiographic
510(k) Number K852528
Device Name BONE DENSITY CT PHANTOM
Applicant
Computerized Imaging Reference Systems, Inc.
2488b Almeda Ave.
Norfolk,  VA  23513
Applicant Contact W. R DRURY
Correspondent
Computerized Imaging Reference Systems, Inc.
2488b Almeda Ave.
Norfolk,  VA  23513
Correspondent Contact W. R DRURY
Regulation Number892.1950
Classification Product Code
IXG  
Date Received06/14/1985
Decision Date 09/26/1985
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
-
-