DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Soyee Product, Inc.
Product code
Code IZL
Device class
Class 2
Regulation
21 CFR 892.1720
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sound Beach, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IZL

product code IZL
Other
3
Total
3

Source: openFDA MAUDE database, through . 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.