V5MS TRANSDUCER— 510(k) K121807
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K121807 for V5MS TRANSDUCER, Substantially Equivalent on 2012-07-10. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Moutain View, CA, US
Recent devices under product code ITX
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K121807
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121807.
Data sourced from openFDA. This site is unofficial and independent of the FDA.