FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K Number: K092742
·
Decision Sep 22, 2009
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
23
Review Days
14
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Basic Information
- Device Name
- NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
- K Number
- K092742
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Neusoft Medical Systems Co., Ltd.
- Date Received
- September 8, 2009
- Decision Date
- September 22, 2009
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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