Computerized Tomography X-Ray System Option
by Siemens Medical Solutions USA, Inc. 3 variants
510(k) K913996
Computerized Tomography X-Ray System Option is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K913996 on 22 Nov 1991, 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 | NumberK913996 | Date22 Nov 1991 | StatusActive |
Official records
- FDA 510(k) database K913996
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- Withdrawn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
Similar devices
Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).
- ALPHARD CONE BEAM CT, MODEL X178 by TAKARA BELMONT CORP.
- SPiN Thoracic Navigation System by VERAN MEDICAL TECHNOLOGIES INC.
- Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System by Canon Medical Systems Corporation
- REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A by Toshiba America Medical Systems, In.C
- IQon Spectral CT by Philips Medical Systems (Cleveland), Inc.
- AQUILION RXL by Toshiba Medical Systems
- Aquilion Lightning (TSX-035A/2, V7.0) by Toshiba Medical Systems
- WRIST RESTRAINT FOR GE9800 C.T. TABLES by Cook, Inc.
- IGUIDE CAPPA by Cas Innovations AG
- SmartView 3D Option by Ge Hangwei Medical System Co., Ltd.