GammaTile

FDA 510(k) K221539 · Gt Medical Technologies

Substantially Equivalent

510(k) numberK221539

Submission

Device name
GammaTile
Applicant
Gt Medical Technologies
Tempe, AZ, US
Received
May 27, 2022
Decision date
November 9, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

Other 510(k)s with product code KXK

510(k)DeviceApplicantDecision
K252296OncoPatchKXK · Traditional Oncopatch, Inc.12/05/2025SE
K242818IsoSphereKXK · Traditional Isoaid, LLC07/15/2025SE
K223465RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional Radiance Therapeutics, Inc.01/11/2023SE
K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional Isoray Medical, Inc.12/31/2020SE
K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special Lv Liberty Vision Corporation05/29/2020SE
K190839GammaTileKXK · Traditional Gt Medical Technologies01/23/2020SE
K191324CivaDermKXK · Traditional Civatech Oncology, Inc.09/20/2019SE
K190296GammaTileKXK · Special Gt Medical Technologies03/13/2019SE
K180515GammaTileKXK · Traditional Isoray Medical, Inc.07/06/2018SE
K171487Sirius MRI Marker NSKXK · Traditional C4 Imaging, LLC08/25/2017SE

More from C4 Imaging, LLC

510(k)DeviceDecision
K190839GammaTileKXK · Traditional 01/23/2020SE
K190296GammaTileKXK · Special 03/13/2019SE

Questions and answers

When was GammaTile cleared by the FDA?

GammaTile (K221539) received a 510(k) decision of Substantially Equivalent on November 9, 2022, 166 days after the submission was received.

What is the product code of K221539?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.