FDA.reportPublic FDA data

510(k) K242818

Device
IsoSphere
Applicant
Isoaid, LLC
510(k) number
K242818
Product code
KXK
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-15
Date received
2024-09-18
Regulation
892.5730
Classification name
Source, Brachytherapy, Radionuclide
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Timothy Bright
Address
7824 Clark Moody Blvd. Port Richey FL US 34668 34668

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KXK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252296OncoPatchOncopatch, Inc.2025-12-05
K223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.2023-01-11
K221539GammaTileGt Medical Technologies2022-11-09
K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.2020-12-31
K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation2020-05-29
K190839GammaTileGt Medical Technologies2020-01-23
K191324CivaDermCivatech Oncology, Inc.2019-09-20
K190296GammaTileGt Medical Technologies2019-03-13
K180515GammaTileIsoray Medical, Inc.2018-07-06
K171487Sirius MRI Marker NSC4 Imaging, LLC2017-08-25
K163572LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceLv Liberty Vision Corp.2017-03-15
K163206SMD-Sr90-DA Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc.2016-12-15
K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceSource Production and Equipment Co., Inc.2016-11-04
K161396SPEC Model M23Source Production and Equipment Co., Inc.2016-08-17
K161395SPEC Model M13Source Production and Equipment Co., Inc.2016-07-06