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 System, Planning, Radiation Therapy Treatment
510(k) Number K151560
Device Name QuickPlan
Applicant
Siris Medical
257 Castro St., Suite 224
Mountain View,  CA  94041
Applicant Contact Colin M Carpenter
Correspondent
Cjp Consulting, Inc.
5831 N Kostner Ave.
Chicago,  IL  60646
Correspondent Contact Cynthia J Pillar
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received06/10/2015
Decision Date 09/11/2015
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
-
-