The following data is part of a premarket notification filed by Nucletron with the FDA for Oncentra Manual Low Dose Rate Treatment Planning.
| Device ID | K113102 |
| 510k Number | K113102 |
| Device Name: | ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | NUCLETRON 7021 Columbia Gateway Dr Suite 200 Columbia, MD 21046 |
| Contact | Micheal Paul |
| Correspondent | Micheal Paul NUCLETRON 7021 Columbia Gateway Dr Suite 200 Columbia, MD 21046 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-19 |
| Decision Date | 2011-12-12 |
| Summary: | summary |