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 K950608
Device Name DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION
Applicant
Lorad Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact MARVIN ROSENBAUM
Correspondent
Lorad Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact MARVIN ROSENBAUM
Regulation Number892.1710
Classification Product Code
IZH  
Date Received02/09/1995
Decision Date 03/02/1995
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
-
-