Neuviz 16 Multi-Slice CT Scanner System
FDA 510(k) K092742 · Neusoft Medical Systems Co., Ltd.
510(k) numberK092742
Submission
- Device name
- Neuviz 16 Multi-Slice CT Scanner System
- Applicant
- Neusoft Medical Systems Co., Ltd.
Shenyang, Liaoning, CN - Received
- September 8, 2009
- Decision date
- September 22, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
Other 510(k)s with product code JAK
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|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K230220 | NeuViz 128 Multi-Slice CT Scanner SystemJAK · Traditional | 10/11/2023SE |
| K171198 | NeuViz 16 Essence Multi-slice CT Scanner SystemJAK · Traditional | 12/07/2017SE |
| K171201 | NeuViz Prime Multi-slice CT Scanner SystemJAK · Traditional | 09/13/2017SE |
| K151383 | NeuViz 128 Multi-slice CT Scanner SystemJAK · Traditional | 11/04/2015SE |
| K151403 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron…KPS · Traditional | 11/02/2015SE |
| K133373 | ClearviewJAK · Traditional | 12/03/2014SE |
| K121792 | Neuviz 64 Multi-Slice CT Scanner SystemJAK · Traditional | 11/16/2012SE |
| K110077 | NeucoloncareLLZ · Traditional | 01/28/2011SE |
| K102435 | Beyondimage WorkstationLLZ · Traditional | 10/15/2010SE |
| K092237 | NSM-S15 SystemLNH · Traditional | 09/09/2009SE |
Questions and answers
When was Neuviz 16 Multi-Slice CT Scanner System cleared by the FDA?
Neuviz 16 Multi-Slice CT Scanner System (K092742) received a 510(k) decision of Substantially Equivalent on September 22, 2009, 14 days after the submission was received.
What is the product code of K092742?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.