The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Somatom Plus 4 With Sliding Gantry Option.
| Device ID | K991600 |
| 510k Number | K991600 |
| Device Name: | SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
| Contact | Alicia Bustos-juergensen |
| Correspondent | Alicia Bustos-juergensen SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-06-09 |
| Summary: | summary |