The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Navisuite Ssi Edition.
| Device ID | K163119 |
| 510k Number | K163119 |
| Device Name: | NaviSuite SSI Edition |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDCOM GMBH RUNDETURMSTR. 50 Darmstadt, DE 64283 |
| Contact | Johannes Messow |
| Correspondent | Johannes Messow MEDCOM GMBH RUNDETURMSTR. 50 Darmstadt, DE 64283 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-05-01 |
| Summary: | summary |