K231666

Substantially Equivalent

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

Applicant: FUJIFILM Healthcare Americas Corporation
Product code: ITX
Advisory panel: Radiology
Date received: 2023-06-07
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.