SYNGO IMAGING (VERSION V30)— 510(k) K071114
Substantially EquivalentSiemens AG Medical Solutions
FDA 510(k) clearance K071114 for SYNGO IMAGING (VERSION V30), Substantially Equivalent on 2007-05-22. 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 K071114
K-number listed on FDA's recall record- Z-1349-2016 — A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
- Z-0319-2016 — Syngo Imaging VB36D_HF02. Radiological image processing system.
- Z-1972-2015 — SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071114.
Data sourced from openFDA. This site is unofficial and independent of the FDA.