The following data is part of a premarket notification filed by Math Resolutions, Llc with the FDA for Dosimetry Check Version 5 Release 1.
| Device ID | K162577 |
| 510k Number | K162577 |
| Device Name: | Dosimetry Check Version 5 Release 1 |
| Classification | Accelerator, Linear, Medical |
| Applicant | MATH RESOLUTIONS, LLC 5975 GALES LANE Columbia, MD 21045 |
| Contact | Wendel Dean Renner |
| Correspondent | Wendel Dean Renner MATH RESOLUTIONS, LLC 5975 GALES LANE Columbia, MD 21045 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-15 |
| Decision Date | 2016-11-18 |
| Summary: | summary |