Scan&GO
by Siemens Medical Solutions USA, Inc.
510(k) K163297
Scan&GO is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K163297 on 24 Mar 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163297 | Date24 Mar 2017 | StatusActive |
Official records
- FDA 510(k) database K163297
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K163297
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Scan&GO 11061696 | 11061696 | 04056869057156 | — | On the market |
Similar devices
Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).
- CT/MASTER, VERSION 1.0 by Columbia Scientific, Inc.
- TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING by Toshiba America Medical Systems, In.C
- ADVANTAGE 3D XR by GE MEDICAL SYSTEMS, INC.
- SOMATOM P30 CT SYSTEMS by Siemens Medical Systems USA, Inc.
- HealthCCSng by Zebra Medical Vision, Ltd.
- CT/T 9800 by General Electric Co.
- Revolution Vibe by GE MEDICAL SYSTEMS, INC.
- Spectral CT 7500 RT by Philips Medical Systems Technologies
- INREACH SYSTEM, MODEL AAS00161-02 by Superdimension, Ltd.
- CT-GUIDE NEEDLE GUIDANCE SYSTEM by Activiews, Ltd.