NeuViz 128 Multi-slice CT Scanner System— 510(k) K151383
Substantially EquivalentNeusoft Medical Systems Co., Ltd.
FDA 510(k) clearance K151383 for NeuViz 128 Multi-slice CT Scanner System, Substantially Equivalent on 2015-11-04. Applicant: Neusoft Medical Systems Co., Ltd..
Clearance details
- Applicant
- Neusoft Medical Systems Co., Ltd.
- Product code
- Code JAK
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenyang, CN
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.