FDA-Device2024-01-24Class II
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
Xcision Medical Systems, LLC
Hazard
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
Sold states
Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
Affected count
4 units
Manufactured in
9176 Red Branch Rd Ste O, N/A, Columbia, MD, United States
Products
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0750-2024Don't want to check this manually?
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