Cleared Traditional

K221539 - GammaTile

K221539 is an FDA 510(k) clearance for GammaTile, manufactured by Gt Medical Technologies. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K221539 · Gt Medical Technologies · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K221539

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.

KXK Device Classification - Class 2, Special Controls

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 31
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