DeviceClearance

Product code ITX— Radiology

ACUSON L538 TRANSDUCER

Classification name
Transducer, Ultrasonic, Diagnostic
Device class
Class 2
Regulation
21 CFR 892.1570
Advisory panel
Radiology
Total cleared
414
First cleared
Most recent

Market context for product code ITX

FDA has cleared 414 devices under product code ITX between 1978 and 2026, filed by 182 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ITX

Adverse events under product code ITX

product code ITX
Death
6
Injury
137
Malfunction
2,036
Total
2,179

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 →

Recent clearances under product code ITX

1–100 of 414

Data sourced from openFDA. This site is unofficial and independent of the FDA.