ELIXBO PM545— 510(k) K130658

Name: FDA 510(k) clearance K130658
Creator: U.S. Food and Drug Administration
Published: 2013-07-19

Substantially Equivalent

Xbo Medical Systems Co., Ltd.

FDA 510(k) clearance K130658 for ELIXBO PM545, Substantially Equivalent on 2013-07-19. Applicant: Xbo Medical Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xbo Medical Systems Co., Ltd.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2013-03-12
Decision date: 2013-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mongolia, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

view all

K261283 — APERTO Lucent MRI System2026-09-16
K261758 — Embrace Vision Neonatal MRI System2026-09-16
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

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.