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, Image Processing, Radiological
510(k) Number K181892
Device Name Ziostation2
Applicant
Ziosoft, Inc.
MitaKokusai Bldg., 1-4-28 Mita
Minato-ku,  JP 108-0073
Applicant Contact Tsuyoshi Nagata
Correspondent
Ziosoft USA Inc.
1301 Shoreway Road, Suite 325
Belmont,  CA  94002
Correspondent Contact Richard Ball
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
JAK   LNH  
Date Received07/13/2018
Decision Date 10/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-