The following data is part of a premarket notification filed by Siemens Medical Solution with the FDA for Syngo Expert-1.
| Device ID | K061449 |
| 510k Number | K061449 |
| Device Name: | SYNGO EXPERT-1 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTION 51 VALLEY STREAM PKWY. E-50 Malvern, PA 19355 |
| Contact | Gary Johnson |
| Correspondent | Gary Johnson SIEMENS MEDICAL SOLUTION 51 VALLEY STREAM PKWY. E-50 Malvern, PA 19355 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-25 |
| Decision Date | 2006-07-25 |
| Summary: | summary |