FDA.reportPublic FDA data

Joanne Hassell

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96804973008794078Joanne Hassell1N2026-01-01762 4th St Secaucus NJ US 07094
30092381853009238185Joanne Hassell1N2026-01-01762 4th St Secaucus NJ US 07094

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1322501830867384K170434Enterprise Imaging XERO Viewer 8.1LLZ2017-07-03
152601830867384K170434Enterprise Imaging XERO Viewer 8.1LLZ2017-07-03
1322501279245399K143397ICIS ViewLLZ2015-06-01
152601279245399K143397ICIS ViewLLZ2015-06-01
152601169242868K142316IMPAX AgilityLLZ2015-01-06
1322501169242868K142316IMPAX AgilityLLZ2015-01-06
152601731412720K111945IMPAX NEXT GENERATIONLLZ2011-08-05
1322501731412720K111945IMPAX NEXT GENERATIONLLZ2011-08-05
152601237565415K081976IMPAX MA3000 DIAGNOSTIC PACS WORKSTATIONLLZ2008-07-28
152601205396545K080013REGISTRATION AND FUSIONLLZ2008-01-17
152602072429460K071972ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONSLLZ2007-07-30
152601631768721K050858ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEMDPS2005-06-29
152601654733130K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.XLLZ2005-04-21
152601571911499K050228AGFA HEARTLAB CARDIOVASCULARLLZ2005-02-18
152601230610983K040555IMPAX CLIENT EMBRACELLZ2004-05-26
152601649724293K040344IMPAX OT3000 ORTHOPEDIC WORKSTATIONLLZ2004-05-12
152601083636073K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHOLLZ2002-09-12
152602026132650K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHOLLZ2002-09-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ172017-07-03
DPS12005-06-29