SYNGO IMAGING (VERSION V31)— 510(k) K081734
Substantially EquivalentSiemens AG Medical Solutions
FDA 510(k) clearance K081734 for SYNGO IMAGING (VERSION V31), Substantially Equivalent on 2008-07-03. 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 K081734
K-number listed on FDA's recall record- Z-0405-2018 — Syngo Imaging version V31 (model # 10014063) 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. It supports the physician in diagnosis and treatment planning.
- 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 K081734.
Data sourced from openFDA. This site is unofficial and independent of the FDA.