The following data is part of a premarket notification filed by Xcision Medical Systems, Llc with the FDA for Gammapod - Model A.
| Device ID | K172706 |
| 510k Number | K172706 |
| Device Name: | GammaPod - Model A |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | Xcision Medical Systems, LLC 9176 Red Branch Road, Suite O Columbia, MD 21045 |
| Contact | Daniel R. Plonski |
| Correspondent | Daniel R. Plonski Xcision Medical Systems, LLC 9176 Red Branch Road, Suite O Columbia, MD 21045 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-07 |
| Decision Date | 2017-12-22 |
| Summary: | summary |