InnoSight Diagnostic Ultrasound System— 510(k) K172056

Substantially Equivalent

Qisda Corporation

FDA 510(k) clearance K172056 for InnoSight Diagnostic Ultrasound System, Substantially Equivalent on 2017-12-13. Applicant: Qisda Corporation.

Clearance details

Applicant: Qisda Corporation
Product code: Code IYO
Advisory panel: Radiology
Date received: 2017-07-06
Decision date: 2017-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.