SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K072365 · decided 2007-10-17
Clearance details
- K-number
- K072365
- Device name
- SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Siemens Medical Solutions USA, Inc., Ultrasound DI
- Decision
- Substantially Equivalent
- Date received
- 2007-08-23
- Decision date
- 2007-10-17
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mountainview, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound sy recall (Z-2149-2011) | Siemens Medical Solutions USA, Inc. | 2011-05-05 |
| 4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens M recall (Z-0826-2011) | Siemens Medical Solutions USA, Inc. | 2010-12-28 |
| ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultras recall (Z-0827-2011) | Siemens Medical Solutions USA, Inc. | 2010-12-28 |