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510(k) K852089

Device
SATURN NUCLEAR MEDICINE COMPUTER SYSTEM
Applicant
TECHNICARE CORP.
510(k) number
K852089
Product code
IYX  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-18
Date received
1985-05-13
Regulation
892.1100
Classification name
Camera, Scintillation (gamma)
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND E URSICK
Address
P.O. Box 5130 Cleveland OH US 44101 44101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IYX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation Safety2023-08-28
K2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLC2023-02-22
K163687OLINDA EXMHermes Medical Solutions AB2017-07-19
K160933Discovery NM 750b BopsyGE Healthcare2016-11-18
K162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-2016-08-18
K143156Sentinella 102; Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-2014-11-18
K123408ERGO IMAGING SYSTEMDigirad Corp.2013-01-15
K111791LUMAGEM MOLECULAR BREAST IMAGING SYSTEMGamma Medica-Ideas Incorporated2011-09-23
K110384DILON 6800 ACELLA (ACELLA)Dilon Technologies, Inc.2011-05-03
K110601SENTINELLA 102General Equipment For Medical Imaging, S.A.2011-03-18
K102231DISCOVERY NM 750BGe Medical Systems Israel, Functional Imaging2010-11-03
K101391SCANDIA-45 GAMMA CAMERA SYSTEMScandia Corporation2010-08-04
K100838ERGO IMAGING SYSTEMDigirad Corp.2010-04-23
K093706PROXISCAN MODEL 101Hybridyne Imaging Technologies, Inc.2010-04-02
K082588GAMMALOC SYSTEM, MODEL 03-00001Dilon Technologies, LLC2009-12-11

Legacy Summary#

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FDA Review#

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