FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
NSM-S15 SYSTEM
K Number: K092237
·
Decision Sep 9, 2009
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
23
Review Days
48
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NSM-S15 SYSTEM
- K Number
- K092237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neusoft Medical Systems Co., Ltd.
- Date Received
- July 23, 2009
- Decision Date
- September 9, 2009
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNH), ordered by most recent decision date.
uMR Astra
FDA 510(k)
FDA Class 2
·Radiology
APERTO Lucent MRI System
FDA 510(k)
FDA Class 2
·Radiology
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
S-scan Open (100001800)
FDA 510(k)
FDA Class 2
·Radiology
nordicAudio (1.0)
FDA 510(k)
FDA Class 2
·Radiology
Embrace Neonatal MRI System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Neusoft Medical Systems Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230220 | NeuViz 128 Multi-Slice CT Scanner System | Oct 11, 2023 | Substantially Equivalent |
| K171198 | NeuViz 16 Essence Multi-slice CT Scanner System | Dec 7, 2017 | Substantially Equivalent |
| K171201 | NeuViz Prime Multi-slice CT Scanner System | Sep 13, 2017 | Substantially Equivalent |
| K151383 | NeuViz 128 Multi-slice CT Scanner System | Nov 4, 2015 | Substantially Equivalent |
| K151403 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System | Nov 2, 2015 | Substantially Equivalent |
| K133373 | CLEARVIEW | Dec 3, 2014 | Substantially Equivalent |
| K121792 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM | Nov 16, 2012 | Substantially Equivalent |
| K110077 | NEUCOLONCARE | Jan 28, 2011 | Substantially Equivalent |
| K102435 | BEYONDIMAGE WORKSTATION | Oct 15, 2010 | Substantially Equivalent |
| K092742 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM | Sep 22, 2009 | Substantially Equivalent |