7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)— 510(k) K902728

Substantially Equivalent

Ausonics Pty , Ltd.

FDA 510(k) clearance K902728 for 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815), Substantially Equivalent on 1991-02-13. Applicant: Ausonics Pty , Ltd..

Clearance details

Applicant: Ausonics Pty , Ltd.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1990-06-21
Decision date: 1991-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suffield, CT, US

Download summary PDF View on FDA.gov ↗

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.