510(k) K172706 ยท IWB System, Radiation Therapy, Radionuclide
GammaPod - Model A
| Applicant | Xcision Medical Systems, LLC, Columbia MD, US |
| Decision | Substantially Equivalent, Dec 22, 2017 |
| Received | Sep 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172706
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.