Identifiers
- 510(k) Number
- K092237 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NSM-S15 SYSTEM is a Nuclear Magnetic Resonance Imaging system classified under device class 2 and medical specialty Radiology. It is an imaging device intended to provide physiological and clinical information non-invasively without the use of ionizing radiation.
The device received FDA 510(k) clearance under K092237 on September 9, 2009, following a traditional submission process. It is manufactured by Neusoft Medical Systems Co., Ltd. and is regulated under 21 CFR 892.1000 with product code LNH.
Frequently asked questions
What is the NSM-S15 SYSTEM used for?
The NSM-S15 SYSTEM is an imaging device intended to provide physiological and clinical information non-invasively without the use of ionizing radiation, as stated in its description for radiological applications.
How was the NSM-S15 SYSTEM authorized for market release?
The device received FDA 510(k) clearance under K092237 on September 9, 2009, following a traditional submission process, indicating it was found substantially equivalent to a legally marketed predicate device.
Who manufactures the NSM-S15 SYSTEM and where is it located?
The NSM-S15 SYSTEM is manufactured by Neusoft Medical Systems Co., Ltd., with the applicant address listed as #3-11, Wenhua Rd., Heping District, Shenyang, Liaoning, China, postal code 110004.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NSM-S15 SYSTEM (K092237) — FDA 510(k) | Innolitics, PDF NSM-S15 SYSTEM 510 (k) K092237 - FDA.report, Neusoft NSM-S15 - allmed.wiki, PDF K092237 - Nsm-s15 System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092237 | Class II | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
Sources (1)
- FDA 510(k) K092237 24 fields · synced Sep 21, 2026