CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM— 510(k) K061488

Substantially Equivalent

Shantou Institute of Ultrasonic Instruments (Siui

FDA 510(k) clearance K061488 for CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM, Substantially Equivalent on 2006-06-30. Applicant: Shantou Institute of Ultrasonic Instruments (Siui.

Clearance details

Applicant: Shantou Institute of Ultrasonic Instruments (Siui
Product code: Code IYN
Advisory panel: Radiology
Date received: 2006-05-31
Decision date: 2006-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.