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, Stationary
510(k) Number K913757
Device Name HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
Applicant
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Applicant Contact AITKENHEAD
Correspondent
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Correspondent Contact AITKENHEAD
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/21/1991
Decision Date 10/30/1991
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
-
-