The following data is part of a premarket notification filed by Medviso Ab with the FDA for Segment Cmr.
| Device ID | K163076 |
| 510k Number | K163076 |
| Device Name: | Segment CMR |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDVISO AB GRIFFELVAGEN 3 Lund, SE Se-22467 |
| Contact | Einar Heiberg |
| Correspondent | Einar Heiberg MEDVISO AB GRIFFELVAGEN 3 Lund, SE Se-22467 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350010100027 | K163076 | 000 |