The following data is part of a premarket notification filed by Nordicneurolab with the FDA for Nordic Tumorex.
| Device ID | K123306 |
| 510k Number | K123306 |
| Device Name: | NORDIC TUMOREX |
| Classification | System, Image Processing, Radiological |
| Applicant | NORDICNEUROLAB MOLLENDALSVEIEN 65C Bergen, Hordaland, NO 5009 |
| Contact | Chandana G Bhandari |
| Correspondent | Chandana G Bhandari NORDICNEUROLAB MOLLENDALSVEIEN 65C Bergen, Hordaland, NO 5009 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-24 |
| Decision Date | 2013-05-20 |
| Summary: | summary |