SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110— 510(k) K070634

Substantially Equivalent

Soyee Product, Inc.

FDA 510(k) clearance K070634 for SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110, Substantially Equivalent on 2007-07-11. Applicant: Soyee Product, Inc..

Clearance details

Applicant: Soyee Product, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2007-03-07
Decision date: 2007-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sound Beach, NY, US

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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.