SYNGO. PLAZA VA20A— 510(k) K101666
Substantially EquivalentSiemens AG Medical Solutions
FDA 510(k) clearance K101666 for SYNGO. PLAZA VA20A, Substantially Equivalent on 2010-08-10. Applicant: Siemens AG Medical Solutions. Device class: 2.
Clearance details
- Applicant
- Siemens AG Medical Solutions
- 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
- Erlangen, DE
Recent devices under product code LLZ
view allMore clearances from Siemens AG Medical Solutions
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 →
Recalls naming K101666
K-number listed on FDA's recall record- Z-2275-2012 — syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
- Z-2078-2012 — Siemens syngo.plaza. Radiological image processing system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101666.
Data sourced from openFDA. This site is unofficial and independent of the FDA.