MULTIX FUSION
FDA 510(k) clearance K121513 · decided 2012-08-10
Clearance details
- K-number
- K121513
- Device name
- MULTIX FUSION
- Applicant
- Siemens Medical Solution
- Decision
- Substantially Equivalent
- Date received
- 2012-05-21
- Decision date
- 2012-08-10
- Days to decision
- 81 days
- Clearance type
- Special
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mavern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinic recall (Z-1505-2014) | Siemens Medical Solutions USA, Inc | 2014-04-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010/S006) | Siemens Medical Solution | 2010-11-05 |
| SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM (P030010/S005) | Siemens Medical Solution | 2010-10-06 |
| MAMMOMAT NOVATION DR (P030010/S004) | Siemens Medical Solution | 2009-06-04 |
| SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM (P030010/S003) | Siemens Medical Solution | 2006-02-15 |
| SIEMENS MAMMOMAT NOVATION FFDM SYSTEM (P030010/S001) | Siemens Medical Solution | 2005-07-07 |
| SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010/S002) | Siemens Medical Solution | 2005-06-20 |
| SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010) | Siemens Medical Solution | 2004-08-20 |