AcuSee AS-P1000 System— 510(k) K202119

Substantially Equivalent

Weipeng (Suzhou) Medical Devices Co., Ltd.

FDA 510(k) clearance K202119 for AcuSee AS-P1000 System, Substantially Equivalent on 2020-10-07. Applicant: Weipeng (Suzhou) Medical Devices Co., Ltd..

Clearance details

Applicant: Weipeng (Suzhou) Medical Devices Co., Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2020-07-30
Decision date: 2020-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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.