The following data is part of a premarket notification filed by Nordicimaginglab As with the FDA for Nordicice Software.
| Device ID | K082441 |
| 510k Number | K082441 |
| Device Name: | NORDICICE SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | NORDICIMAGINGLAB AS MOLLENDALSVEIEN 65C Bergen, NO 5009 |
| Contact | Stian Scisly Sagevik |
| Correspondent | Stian Scisly Sagevik 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 | 2008-08-25 |
| Decision Date | 2008-11-21 |
| Summary: | summary |