The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Scope(with Syngo Ct Vc30-easyiq Version), Somatom Scope Power(with Syngo Ct Vc30-easyiq Version).
| Device ID | K151749 |
| 510k Number | K151749 |
| Device Name: | Somatom Scope(with Syngo CT VC30-easyIQ Version), SOMATOM Scope Power(with Syngo CT VC30-easyIQ Version) |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 |
| Contact | Eve Davis |
| Correspondent | Kimberly Mangum Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Code 65-1A 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 | 2015-06-29 |
| Decision Date | 2016-03-18 |
| Summary: | summary |