SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION— 510(k) K120315
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K120315 for SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION, Substantially Equivalent on 2012-04-13. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mavern, PA, US
Recent devices under product code LLZ
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.