Cleared Traditional

K172706 - GammaPod - Model A

K172706 is an FDA 510(k) clearance for GammaPod - Model A, manufactured by Xcision Medical Systems, LLC. The device is a Class 2 Radiology device with product code IWB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K172706 · Xcision Medical Systems, LLC · Radiology device
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Dec 2017
Decision
106d
Days
Class 2
Risk

K172706 is an FDA 510(k) clearance for the GammaPod - Model A. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Xcision Medical Systems, LLC (Columbia, US). The FDA issued a Cleared decision on December 22, 2017 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5750 - 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 Xcision Medical Systems, LLC devices

FDA 510(k) Submission Details - K172706

510(k) Number K172706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2017
Decision Date December 22, 2017
Days to Decision 106 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IWB Device Classification - Class 2, Special Controls

Product Code IWB System, Radiation Therapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5750
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 - IWB System, Radiation Therapy, Radionuclide

All 22
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K172706.
GammaPod
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Leksell Gamma Knife Icon
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Leksell Gamma Knife Perfexion
K151159 · Elekta Instrument AB · Oct 2015
Leksell Gamma Knife Icon
K151561 · Elekta Instrument AB · Aug 2015