MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
FDA 510(k) clearance K071308 · decided 2007-08-16
Clearance details
- K-number
- K071308
- Device name
- MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
- Applicant
- Neusoft Medical Systems Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-09
- Decision date
- 2007-08-16
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenyang, CN
- Third-party review
- No
- Expedited review
- No
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