MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
FDA 510(k) clearance K063085 · decided 2006-11-14
Clearance details
- K-number
- K063085
- Device name
- MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-10
- Decision date
- 2006-11-14
- Days to decision
- 35 days
- Clearance type
- Special
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUS recall (Z-1961-2011) | Siemens Medical Solutions USA, Inc. | 2011-04-12 |
| Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System; Mod recall (Z-2230-2008) | Siemens Medical Solutions USA, Inc. | 2008-09-11 |
| ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. recall (Z-0661-2008) | Siemens Medical Solutions USA, Inc. | 2008-04-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008) | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007) | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006) | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005) | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003) | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001) | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002) | Siemens Medical Solutions USA, Inc. | 2016-01-13 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011) | Siemens Medical Solutions USA, Inc. | 2015-04-21 |