ACUSON X300 ULTRASOUND SYSTEM
FDA 510(k) clearance K072676 · decided 2007-12-18
Clearance details
- K-number
- K072676
- Device name
- ACUSON X300 ULTRASOUND SYSTEM
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-21
- Decision date
- 2007-12-18
- Days to decision
- 88 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 |
|---|---|---|
| Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 103485 recall (Z-2147-2011) | Siemens Medical Solutions USA, Inc. | 2011-05-06 |
| Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (mode recall (Z-2061-2011) | Siemens Medical Solutions USA, Inc. | 2011-04-25 |
| Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model num recall (Z-2065-2011) | Siemens Medical Solutions USA, Inc. | 2011-04-25 |
| ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options install recall (Z-1838-2011) | Siemens Medical Solutions USA, Inc., Mountain View, CA | 2011-03-28 |
| Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to recall (Z-0111-2009) | Siemens Medical Solutions USA, Inc. | 2008-10-10 |
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 |