FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
NeuViz 128 Multi-slice CT Scanner System
K Number: K151383
·
Decision Nov 4, 2015
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
23
Review Days
166
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Basic Information
- Device Name
- NeuViz 128 Multi-slice CT Scanner System
- K Number
- K151383
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neusoft Medical Systems Co., Ltd.
- Date Received
- May 22, 2015
- Decision Date
- November 4, 2015
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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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 |
| 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 |
| K092237 | NSM-S15 SYSTEM | Sep 9, 2009 | Substantially Equivalent |