NSM-S15 SYSTEM— 510(k) K092237
Substantially EquivalentNeusoft Medical Systems Co., Ltd.
FDA 510(k) clearance K092237 for NSM-S15 SYSTEM, Substantially Equivalent on 2009-09-09. Applicant: Neusoft Medical Systems Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Neusoft Medical Systems Co., Ltd.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenyang, Liaoning, CN
Recent devices under product code LNH
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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 LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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.