The following data is part of a premarket notification filed by Ivs Solutions Ag with the FDA for Codiagnostix (r) 5.72.
| Device ID | K071636 |
| 510k Number | K071636 |
| Device Name: | CODIAGNOSTIX (R) 5.72 |
| Classification | System, Image Processing, Radiological |
| Applicant | IVS SOLUTIONS AG ANNABERGET STRASSE 240 Chemnitz, Saxony, DE 09125 |
| Contact | Frank Stockmann |
| Correspondent | Frank Stockmann IVS SOLUTIONS AG ANNABERGET STRASSE 240 Chemnitz, Saxony, DE 09125 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-15 |
| Decision Date | 2007-08-09 |
| Summary: | summary |