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 K041213
Device Name 3DSCOPE
Applicant
DIREX SYSTEMS CORP.
11 MERCER RD.
NATICK,  MA  01760
Applicant Contact LARISA GERSHTEIN
Correspondent
DIREX SYSTEMS CORP.
11 MERCER RD.
NATICK,  MA  01760
Correspondent Contact LARISA GERSHTEIN
Regulation Number892.1650
Classification Product Code
OXO  
Date Received05/10/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-