NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
FDA 510(k) clearance K090173 · decided 2009-02-05
Clearance details
- K-number
- K090173
- Device name
- NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
- Applicant
- Neusoft Medical Systems Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-23
- Decision date
- 2009-02-05
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenyang, Liaoning, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography recall (Z-1573-2016) | Philips and Neusoft Medical Systems Co., Ltd. | 2016-04-27 |
| NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. recall (Z-1165-2013) | Philips And Neusoft Medical Systems Co., Ltd. | 2013-04-23 |
| NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT recall (Z-0466-2013) | Philips And Neusoft Medical Systems Co., Ltd. | 2012-12-04 |
| NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a P recall (Z-2083-2012) | Philips And Neusoft Medical Systems Co., Ltd. | 2012-07-26 |
| NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a P recall (Z-2241-2011) | Philips And Neusoft Medical Systems Co., Ltd. | 2011-05-23 |