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Xcision Medical Systems, LLC

US

Last updated September 17, 2026

About

GammaPod is designed to deliver stereotactic radiotherapy treatments for breast cancer in one to five sessions, a significantly more efficient, cost-effective and patient-friendly option compared to current accelerated, hypofractionated and conventional treatments.

From the manufacturer's own website. Source

Information

Country
US
Address
9176 RED BRANCH RD STE O, Columbia, MD, 21045
Website
xcision.com
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3014273653
DUNS Number
—

Catalogue (48)

DeviceModel / ReferenceRegistriesClassStatus
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Treatment Planning System Model A
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Suction Pump
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Breast Cup Flange
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Imager Loader and Couch Model B
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Outer Breast Cup
FDA UDI
Class IIActive
GammaPod™ Model A
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Outer Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Breast Cup Flange
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Outer Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Treatment Control System Model A
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Bolus
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Breast Cup Flange
FDA UDI
Class IIActive
GammaPod™ Breast Immobilization and Localization System Inner Breast Cup
FDA UDI
Class IIActive
GammaPod - Model A K172706
FDA 510(k)
Class IIActive
GammaPod K180571
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Nov 30, 2023Z-0750-2024—open, classified

Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

Jul 3, 2019Z-2081-2019—terminated

One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.