510(k) Report

FDA applicant

Xcision Medical Systems, LLC

Columbia, MD2 decisions2017–20182 recalls

FDA records 2 decisions for Xcision Medical Systems, LLC (Columbia, MD) from 2017 to 2018: 2 510(k) clearances. All are in product code IWB (System, Radiation Therapy, Radionuclide). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Xcision Medical Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 12018: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2023

2019: 12023: 1
2017high 1 (2019) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Xcision Medical Systems, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IWBSystem, Radiation Therapy, Radionuclide2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K172706GammaPod - Model AXcision Medical Systems, LLC · 20171cites it

What has FDA decided for it lately?

  • K180571GammaPodXcision Medical Systems, LLC · 20182 recalls
  • K172706GammaPod - Model AXcision Medical Systems, LLC · 20171 recall

All 2 as Xcision Medical Systems, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K172706GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System.…Nov 30, 2023Class II
  • K180571GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage…Jul 3, 2019Class II