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 K942367
Device Name AXT 1400 SPOTFILM DEVICE
Applicant
Applied X-Ray Technologies, Inc.
2727 W. 92nd Ave.,
Suite 10
Denver,  CO  80221
Applicant Contact HOWARD THOMAS
Correspondent
Applied X-Ray Technologies, Inc.
2727 W. 92nd Ave.,
Suite 10
Denver,  CO  80221
Correspondent Contact HOWARD THOMAS
Regulation Number892.1670
Classification Product Code
IXL  
Date Received05/18/1994
Decision Date 06/06/1994
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
-
-