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 Device, Spot-Film
510(k) Number K882492
Device Name A.X.T. SPOTFILM DEVICE
Applicant
Applied X-Ray Technologies, Inc.
10470 N. King Cir
Westminster,  CO  80030
Applicant Contact HOWARD C THOMAS
Correspondent
Applied X-Ray Technologies, Inc.
10470 N. King Cir
Westminster,  CO  80030
Correspondent Contact HOWARD C THOMAS
Regulation Number892.1670
Classification Product Code
IXL  
Date Received06/16/1988
Decision Date 07/21/1988
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
-
-