CTS-200 WITH EZU-PL21 TRANSDUCER— 510(k) K963068
Substantially EquivalentShantou Institute of Ultrasonic Instuments
FDA 510(k) clearance K963068 for CTS-200 WITH EZU-PL21 TRANSDUCER, Substantially Equivalent on 1997-05-29. Applicant: Shantou Institute of Ultrasonic Instuments. Device class: 2.
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instuments
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Creek, CA, US
Recent devices under product code IYO
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- K081110 — SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
- K070982 — CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
- K061083 — CTS-7700
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.