NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0— 510(k) K080540
Substantially EquivalentNeusoft Medical Systems Co., Ltd.
FDA 510(k) clearance K080540 for NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0, Substantially Equivalent on 2008-03-13. Applicant: Neusoft Medical Systems Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Neusoft Medical Systems Co., Ltd.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenyang, Liaoning, CN
Recent devices under product code JAK
view allMore clearances from Neusoft Medical Systems Co., Ltd.
view all- K230220 — NeuViz 128 Multi-Slice CT Scanner System
- K171198 — NeuViz 16 Essence Multi-slice CT Scanner System
- K171201 — NeuViz Prime Multi-slice CT Scanner System
- K151383 — NeuViz 128 Multi-slice CT Scanner System
- K151403 — Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
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.