Chrysalis Intelligence · Sponsors · Siemens Healthcare GmbH

Siemens Healthcare GmbH

Erlanger, DE · 24 510(k) clearances

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Total clearances
24
2020-07-01 → 2026-06-16
Last 12 months
6
Product codes
8
Most recent
2026-06-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LLZ System, Image Processing, Radiological Class II Radiology 8 2025-09-09
QIH Automated Radiological Image Processing Software Class II Radiology 5 2026-04-10
QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation Class II Radiology 2 2026-06-16
QKB Radiological Image Processing Software For Radiation Therapy Class II Radiology 2 2026-04-10
LNH — — — 2 2025-12-19
JAK System, X-Ray, Tomography, Computed Class II Radiology 2 2024-03-21
OEB — — — 2 2023-07-19
QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer Class II Radiology 1 2025-03-05
Filings

All 510(k) clearances (24)

Date K-number Device Code Class Specialty
2026-06-16 K253264 myAblation Guide (VC10A) QTZ Class II Radiology
2026-04-10 K253689 syngo Dynamics (VA41F) QIH Class II Radiology
2026-04-10 K252548 AI-Rad Companion Organs RT QKB Class II Radiology
2026-01-22 K253057 AI-Rad Companion Brain MR QIH Class II Radiology
2025-12-19 K252838 MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise LNH — —
2025-09-09 K252608 AI-Rad Companion Prostate MR LLZ Class II Radiology
2025-06-16 K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile LNH — —
2025-04-03 K242551 syngo Dynamics (Version VA41D) QIH Class II Radiology
2025-03-27 K242745 AI-Rad Companion Organs RT QKB Class II Radiology
2025-03-05 K241770 Prostate MR AI (VA10A) QDQ Class II Radiology
2024-08-06 K240796 myAblation Guide (VB80A) QTZ Class II Radiology
2024-05-23 K240294 Syngo Carbon Enterprise Access (VA40A) LLZ Class II Radiology
2024-03-21 K233753 AI-Rad Companion (Pulmonary) JAK Class II Radiology
2023-12-21 K232744 syngo Virtual Cockpit (VB10A) LLZ Class II Radiology
2023-12-01 K232856 Syngo Carbon Clinicals QIH Class II Radiology
2023-07-19 K231157 syngo.CT Lung CAD (Version VD30) OEB — —
2023-03-21 K230561 Syngo Carbon Space VA30A LLZ Class II Radiology
2023-02-13 K230196 syngo.via View&GO VA40A LLZ Class II Radiology
2022-10-14 K221501 syngo.via View&GO LLZ Class II Radiology
2022-08-11 K213713 AI-Rad Companion (Pulmonary) JAK Class II Radiology
2022-06-21 K213665 Syngo Carbon Space VA20A LLZ Class II Radiology
2022-04-15 K213706 AI-Rad Companion Brain MR QIH Class II Radiology
2021-03-31 K203258 syngo.CT Lung CAD OEB — —
2020-07-01 K201477 syngo.via View&GO LLZ Class II Radiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence