The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Go.platform Scanners - Somatom Go.now, Go.up, Go.all, Go.top, Somatom X. Platform Scanners - Somatom X.cite And Somatom X.ceed, Scan&go Software.
| Device ID | K211373 |
| 510k Number | K211373 |
| Device Name: | SOMATOM Go.Platform Scanners - SOMATOM Go.Now, Go.Up, Go.All, Go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite And SOMATOM X.ceed, Scan&GO Software |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2021-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869231051 | K211373 | 000 |