Cleared Traditional

K180515 - GammaTile

K180515 is the FDA 510(k) clearance for GammaTile by Isoray Medical, Inc.. It is a Class 2 Radiology device (product code KXK) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K180515 · Isoray Medical, Inc. · Radiology device
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Jul 2018
Decision
129d
Days
Class 2
Risk

K180515 is an FDA 510(k) clearance for the GammaTile. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoray Medical, Inc. (Richland, US). The FDA issued a Cleared decision on July 6, 2018 after a review of 129 days - within the typical 510(k) review window.

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 Isoray Medical, Inc. devices

Submission Details

510(k) Number K180515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2018
Decision Date July 06, 2018
Days to Decision 129 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
22d slower than avg
Panel avg: 107d · This submission: 129d
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 18
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K180515.
GammaTile
K190839 · Gt Medical Technologies · Jan 2020
CivaDerm
K191324 · Civatech Oncology, Inc. · Sep 2019
GammaTile
K190296 · Gt Medical Technologies · Mar 2019
VariSeed 9.0
K150636 · Varian Medical Systems, Inc. · May 2015
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856 · C.R. Bard, Inc. · May 2014
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc. · Dec 2009