S9 Portable Digital Color Doppler Ultrasound System
FDA 510(k) clearance K152165 · decided 2015-08-26
Clearance details
- K-number
- K152165
- Device name
- S9 Portable Digital Color Doppler Ultrasound System
- Applicant
- Sonoscape Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-03
- Decision date
- 2015-08-26
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software applicatio recall (Z-2109-2014) | Philips Ultrasound, Inc. | 2014-07-23 |
| QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software applicat recall (Z-2110-2014) | Philips Ultrasound, Inc. | 2014-07-23 |