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 programmer, changer, film/cassette, radiographic
510(k) Number K874451
Device Name OMNIPLANE 200 FILM CHANGER SYSTEM
Applicant
MEDRAD, INC.
271 KAPPA DR.
PITTSBURGH,  PA  15238 -2870
Applicant Contact RUEY C DEMPSEY
Correspondent
MEDRAD, INC.
271 KAPPA DR.
PITTSBURGH,  PA  15238 -2870
Correspondent Contact RUEY C DEMPSEY
Regulation Number892.1870
Classification Product Code
IZP  
Date Received10/28/1987
Decision Date 02/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-