The following data is part of a premarket notification filed by Nordicimaginglab As with the FDA for Nordicbrainex Software, Version 1.0.
| Device ID | K092102 |
| 510k Number | K092102 |
| Device Name: | NORDICBRAINEX SOFTWARE, VERSION 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | NORDICIMAGINGLAB AS MOLLENDALSVEIEN 65C Bergen, NO 5009 |
| Contact | Chandana Gurung Bhandari |
| Correspondent | Chandana Gurung Bhandari NORDICIMAGINGLAB AS MOLLENDALSVEIEN 65C Bergen, 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 | 2009-07-14 |
| Decision Date | 2009-08-25 |
| Summary: | summary |