GammaTile— 510(k) K190839

Substantially Equivalent

Gt Medical Technologies

FDA 510(k) clearance K190839 for GammaTile, Substantially Equivalent on 2020-01-23. Applicant: Gt Medical Technologies. Device class: 2.

Clearance details

Applicant: Gt Medical Technologies
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2019-04-01
Decision date: 2020-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXK

K252296 — OncoPatch2025-12-05
K242818 — IsoSphere2025-07-15
K223465 — RadianceTx Radionuclide Brachytherapy Source2023-01-11
K221539 — GammaTile2022-11-09
K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles2020-12-31

More clearances from Gt Medical Technologies

K190296 — GammaTile2019-03-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.