SIGNA Champion— 510(k) K233728

Name: FDA 510(k) clearance K233728
Creator: U.S. Food and Drug Administration
Published: 2024-01-19

Substantially Equivalent

Ge Healthcare (Tianjin) Company Limited

FDA 510(k) clearance K233728 for SIGNA Champion, Substantially Equivalent on 2024-01-19. Applicant: Ge Healthcare (Tianjin) Company Limited. Device class: 2.

Clearance details

Applicant: Ge Healthcare (Tianjin) Company Limited
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2023-11-21
Decision date: 2024-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Ge Healthcare (Tianjin) Company Limited

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K223439 — SIGNA Victor2023-02-13
K213603 — SIGNA Artist Evo2022-02-11
K211980 — SIGNA Prime2022-01-16
K202238 — SIGNA Artist2020-09-04
K192426 — Signa Voyager, Signa Voyager Quantum2019-10-01

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.