The following data is part of a premarket notification filed by Nordicimaginglab As with the FDA for Modification To Nordicice Software.
| Device ID | K090546 |
| 510k Number | K090546 |
| Device Name: | MODIFICATION TO NORDICICE SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | NORDICIMAGINGLAB AS MOLLENDALSVEIEN 65C Bergen, NO 5009 |
| Contact | Chandana G Bhandari |
| Correspondent | Chandana G 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 | 2009-03-02 |
| Decision Date | 2009-06-08 |
| Summary: | summary |