Data / Medical devices / United States / Xcision Medical Systems, LLC
Xcision Medical Systems, LLC: FDA-registered device maker in Columbia, MD, United States, 1 510(k) clearance
Xcision Medical Systems, LLC is registered with the FDA (registration 3014273653) in Columbia, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 4, 2018. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014273653
- Address
- 9176 Red Branch RD Ste O, Columbia, MD, United States, 21045
- Owner or operator
- Xcision Medical Systems (10056902)
- Roles
- Manufacturer
- First device listed
- December 7, 2018
- Registered through
- 2026
- Brand names listed
- GammaPod Model A
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Radiation Therapy, Radionuclide | IWB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2018 | K180571 | GammaPod | IWB | Substantially Equivalent | Xcision Medical Systems, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 30, 2023 | 93684 | Class II | Ongoing | 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 breas | Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected | accessdata.fda.gov |
| July 3, 2019 | 83342 | Class II | Terminated | 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 | One bolt on the V motor was not fully tightened which caused a drift of.13 degrees in alignment resulting in reduced dose output. | accessdata.fda.gov |
Compare with other makers
Updated January 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.