FDA.reportPublic FDA data

510(k) K230221

Device
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
Applicant
Versant Medical Physics and Radiation Safety
510(k) number
K230221
Product code
IYX
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-28
Date received
2023-01-26
Regulation
892.1100
Classification name
Camera, Scintillation (Gamma)
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Darrell R. Fisher
Address
119 N. Church St. Kalamazoo MI US 49007 49007

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IYX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K092471MODEL SENTINELLA 102General Equipment For Medical Imaging, S.A.2009-10-02