FDA.reportPublic FDA data

ZIOSOFT, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066213323006621332ZIOSOFT, INC.1N2026-01-01Mitakokusai Bldg. 1-4-28 Mita Minato-ku Tokyo JP 108-0073
30093944913009394491ZIOSOFT USA INC.1Y2026-01-0139899 Balentine Drive, STE 116 Newark CA US 94560

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2044431495723282K200315Ziostation2LLZ2020-05-05
2044431916092335K181892Ziostation2LLZ2018-10-09
2044431228282544K151212Ziostation2LLZ2015-11-04
2044431935720801K130552CT PULMONARY ANALYSISJAK2014-01-13
2044432043587110K091262MR CARDIAC FUNCTION ANALYSISLLZ2009-06-29
2044431316733575K083446CARDIAC FUNCTION ANALYSIS, CALCIUM SCORINGLLZ2009-03-31
2044431177291917K083084CT BRAIN PERFUSION FOR ZIOSTATIONLLZ2008-12-19
2044431072965915K070205ZIOSTATIONLLZ2007-03-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ72020-05-05
JAK12014-01-13

PMN#

GUDID#

Ziostation2 - Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging toolsand techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound,Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, RT Image.

ZIOSOFT, INC.

2017-06-30