CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM— 510(k) K061488
Substantially EquivalentShantou 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. Device class: 2.
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instruments (Siui
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dublin, CA, US
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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, 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.