The following data is part of a premarket notification filed by Elekta Inc. D/b/a Nucletron Corporation with the FDA for Oncentra, Oncentra External Beam, Oncentra Brachy.
| Device ID | K121448 |
| 510k Number | K121448 |
| Device Name: | ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ELEKTA INC. D/B/A NUCLETRON CORPORATION 7 ST. PAUL ST, STE 1660 Baltimore, MD 21202 |
| Contact | Thomas Valentine |
| Correspondent | Thomas Valentine ELEKTA INC. D/B/A NUCLETRON CORPORATION 7 ST. PAUL ST, STE 1660 Baltimore, MD 21202 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-15 |
| Decision Date | 2012-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213052758 | K121448 | 000 |