The following data is part of a premarket notification filed by Math Resolutions, Llc. with the FDA for Dosimetry Check Version 4 Release 1.
| Device ID | K132605 |
| 510k Number | K132605 |
| Device Name: | DOSIMETRY CHECK VERSION 4 RELEASE 1 |
| Classification | Accelerator, Linear, Medical |
| Applicant | MATH RESOLUTIONS, LLC. 5975 GALES LN. Columbia, MD 21045 |
| Contact | Wendel Dean Renner |
| Correspondent | Wendel Dean Renner MATH RESOLUTIONS, LLC. 5975 GALES LN. 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 | 2013-08-20 |
| Decision Date | 2013-11-14 |
| Summary: | summary |