The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Equal Dose.
| Device ID | K103515 |
| 510k Number | K103515 |
| Device Name: | EQUAL DOSE |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | NUCLETRON CORPORATION 7021 COLUMBIA GATEWAY DR. SUITE 200 Columbia, MD 21046 -2133 |
| Contact | Manal Yousof |
| Correspondent | Manal Yousof NUCLETRON CORPORATION 7021 COLUMBIA GATEWAY DR. SUITE 200 Columbia, MD 21046 -2133 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-30 |
| Decision Date | 2011-09-15 |
| Summary: | summary |