NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM— 510(k) K062451
Substantially EquivalentNeusoft Medical Systems Co., Ltd.
FDA 510(k) clearance K062451 for NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM, Substantially Equivalent on 2006-09-28. 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 →
Recalls naming K062451
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062451.
Data sourced from openFDA. This site is unofficial and independent of the FDA.