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 Accelerator, Linear, Medical
510(k) Number K160057
Device Name ArcCHECK-MR
Applicant
Sun Nuclear Corporation
3275 Suntree Blvd.
Melbourne,  FL  32940
Applicant Contact James Luker
Correspondent
Sun Nuclear Corporation
3275 Suntree Blvd.
Melbourne,  FL  32940
Correspondent Contact James Luker
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/12/2016
Decision Date 05/13/2016
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
-
-