The following data is part of a premarket notification filed by Brainreader Aps with the FDA for Neuroreader Medical Image Processing Software.
| Device ID | K140828 |
| 510k Number | K140828 |
| Device Name: | NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | BRAINREADER APS SKAGENVEJ 21 Egaa, DK 8250 |
| Contact | Mette Munch |
| Correspondent | Mette Munch BRAINREADER APS SKAGENVEJ 21 Egaa, DK 8250 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2015-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700002060440 | K140828 | 000 |
| 05700002060433 | K140828 | 000 |
| 05700002060419 | K140828 | 000 |
| 05700002060402 | K140828 | 000 |
| 05700002060457 | K140828 | 000 |
| 05700002060464 | K140828 | 000 |
| 05700002060471 | K140828 | 000 |