syngo.MR Applications (VB80)— 510(k) K253495

Name: FDA 510(k) clearance K253495
Creator: U.S. Food and Drug Administration
Published: 2025-11-20

Substantially Equivalent

Siemens Healthineers AG

FDA 510(k) clearance K253495 for syngo.MR Applications (VB80), Substantially Equivalent on 2025-11-20. Applicant: Siemens Healthineers AG. Device class: 2.

Clearance details

Applicant: Siemens Healthineers AG
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-10-28
Decision date: 2025-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Forchheim, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Siemens Healthineers AG

view all

K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31
K253690 — LungMaps2026-06-15
K253023 — BIOGRAPH One2026-01-15
K251059 — Syngo Carbon Clinicals (VA41)2025-10-24

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.