Cleared Traditional

GammaTile (K221539) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221539 · Gt Medical Technologies · Radiology device
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Nov 2022
Decision
166d
Days
Class 2
Risk

K221539 is an FDA 510(k) clearance for the GammaTile. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Gt Medical Technologies (Tempe, US). The FDA issued a Cleared decision on November 9, 2022 after a review of 166 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gt Medical Technologies devices

Submission Details

510(k) Number K221539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2022
Decision Date November 09, 2022
Days to Decision 166 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 107d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 16
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K221539.
OncoPatch
K252296 · Oncopatch, Inc. · Dec 2025
IsoSphere
K242818 · Isoaid, LLC · Jul 2025
RadianceTx Radionuclide Brachytherapy Source
K223465 · Radiance Therapeutics, Inc. · Jan 2023
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
K202267 · Isoray Medical, Inc. · Dec 2020
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
K193602 · Lv Liberty Vision Corporation · May 2020
GammaTile
K190839 · Gt Medical Technologies · Jan 2020