Xcision Medical Systems, LLC

Columbia, MD, US

XCISION MEDICAL SYSTEMS, LLC appears in FDA device records in Columbia, MD. FDA records list 2 510(k) clearances between 2017-12-22 and 2018-04-04, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 2
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Xcision Medical Systems, LLC between 2017 and 2018. The busiest year on record is 2017, with 1. The most recent is 2018, with 1.

Clearances by year, as a table

510(k) clearance decisions for Xcision Medical Systems, LLC, by decision year
Year	Clearances
2017	1
2018	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K180571	GammaPod	IWB	Substantially Equivalent	2018-04-04
K172706	GammaPod - Model A	IWB	Substantially Equivalent	2017-12-22

Registered establishments

FDA registered establishments for Xcision Medical Systems, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3014273653	3014273653	XCISION MEDICAL SYSTEMS, LLC	9176 RED BRANCH RD STE O, Columbia, MD 21045 US	2026	IWB

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

IWBSystem, Radiation Therapy, Radionuclide

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0750-2024	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.	Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected	Class II	2023-11-30	Open, Classified
Z-2081-2019	GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device 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.	One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.	Class II	2019-07-03	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain