510(k) K180571 ยท IWB System, Radiation Therapy, Radionuclide
GammaPod
| Applicant | Xcision Medical Systems, LLC, Columbia MD, US |
| Decision | Substantially Equivalent, Apr 4, 2018 |
| Received | Mar 5, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Xcision Medical Systems, LLC 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 parti Open, Classified |
IWB | None listed |
| Jul 3, 2019 | Xcision Medical Systems, LLC 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 Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.