LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM— 510(k) K913472

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K913472 for LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM, Substantially Equivalent on 1992-03-13. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code ITX
Advisory panel: Radiology
Date received: 1991-08-05
Decision date: 1992-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.