Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine— 510(k) K220700

Name: FDA 510(k) clearance K220700
Creator: U.S. Food and Drug Administration
Published: 2022-05-04

Substantially Equivalent

Yian Medical Technology (Haining) Co., Ltd.

FDA 510(k) clearance K220700 for Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine, Substantially Equivalent on 2022-05-04. Applicant: Yian Medical Technology (Haining) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yian Medical Technology (Haining) Co., Ltd.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 2022-03-10
Decision date: 2022-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.