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 K842102
Device Name LORAD
Applicant
Lorad Medical Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Lorad Medical Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1710
Classification Product Code
IZH  
Date Received05/25/1984
Decision Date 07/17/1984
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
-
-