SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM— 510(k) K984203
Substantially EquivalentShantou Institute of Ultrasonic Instuments
FDA 510(k) clearance K984203 for SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 1999-11-01. Applicant: Shantou Institute of Ultrasonic Instuments. Device class: 2.
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instuments
- Product code
- Code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Creek, CA, US
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More clearances from Shantou Institute of Ultrasonic Instuments
view all- K113613 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
- K092907 — DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR
- K081110 — SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
- K070982 — CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
- K061083 — CTS-7700
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.