Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Neusoft GroupLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Neusoft Medical Systems with 23 510(k) clearances, 9 device recalls and 1 AI-enabled device. The most recent is a 510(k) clearance dated Oct 11, 2023: NeuViz 128 Multi-Slice CT Scanner System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 11, 2023 | NeuViz 128 Multi-Slice CT Scanner SystemK230220 · JAK | 510(k) clearances |
| Oct 11, 2023 | NeuViz 128 Multi-Slice CT Scanner SystemK230220 · Radiology | AI-enabled devices |
| Dec 7, 2017 | NeuViz 16 Essence Multi-slice CT Scanner SystemK171198 · JAK | 510(k) clearances |
| Sep 13, 2017 | NeuViz Prime Multi-slice CT Scanner SystemK171201 · JAK | 510(k) clearances |
| Nov 4, 2015 | NeuViz 128 Multi-slice CT Scanner SystemK151383 · JAK | 510(k) clearances |
| Nov 2, 2015 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) SystemK151403 · KPS | 510(k) clearances |
| Dec 3, 2014 | CLEARVIEWK133373 · JAK | 510(k) clearances |
| Mar 8, 2014 | Neusoft NeuViz 64 Multi-slice CT Scanner SystemClass II · The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinne | Device recalls |
| Nov 16, 2012 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEMK121792 · JAK | 510(k) clearances |
| Jan 28, 2011 | NEUCOLONCAREK110077 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
