MRI ECG Patient Cable— 510(k) K192852

Name: FDA 510(k) clearance K192852
Creator: U.S. Food and Drug Administration
Published: 2020-03-28

Substantially Equivalent

Ivy Biomedical Systems, Inc.

FDA 510(k) clearance K192852 for MRI ECG Patient Cable, Substantially Equivalent on 2020-03-28. Applicant: Ivy Biomedical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ivy Biomedical Systems, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2019-10-03
Decision date: 2020-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

view all

K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star2026-09-01
K262622 — Swoop® Portable MR Imaging® System2026-08-19
K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31

More clearances from Ivy Biomedical Systems, Inc.

view all

K240087 — RT Carbon ECG Leads2024-09-13
K202138 — Cardiac Trigger Monitor2021-05-14
K203653 — MRI PPG Patient Cable2021-03-02
K171778 — MR Wireless Gating System, Model WGS-1002018-03-14
K170828 — Cardiac Trigger Monitor2017-05-17

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.