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 Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K051754
Device Name ORTHOSCAN, ORTHOSCAN HD
Applicant
ORTHOSCAN, INC.
8585 E HARTFORD DRIVE
SCOTTSDALE,  AZ  85255
Applicant Contact ARLEN ISSETTE
Correspondent
ORTHOSCAN, INC.
8585 E HARTFORD DRIVE
SCOTTSDALE,  AZ  85255
Correspondent Contact ARLEN ISSETTE
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received06/29/2005
Decision Date 08/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-