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 K060906
Device Name CALYPSO 4D LOCALIZATION SYSTEM
Applicant
Calypso Medical Technologies, Inc.
2101 Fourth Ave. Suite 1550
Seattle,  WA  98121
Applicant Contact ERIC MEIER
Correspondent
Calypso Medical Technologies, Inc.
2101 Fourth Ave. Suite 1550
Seattle,  WA  98121
Correspondent Contact ERIC MEIER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/03/2006
Decision Date 07/28/2006
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
-
-