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 K141800
Device Name PERFRACTION
Applicant
Sun Nuclear Corporation
3275 Suntree Blvd.
Melbourne,  FL  32940
Applicant Contact JEFF KAPATOES
Correspondent
Sun Nuclear Corporation
3275 Suntree Blvd.
Melbourne,  FL  32940
Correspondent Contact JEFF KAPATOES
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/03/2014
Decision Date 09/26/2014
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
-
-