Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear Array
FDA 510(k) K101008 · Shantou Institute of Ultrasonic Instruments (Siui
510(k) numberK101008
Submission
- Device name
- Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear Array
- Applicant
- Shantou Institute of Ultrasonic Instruments (Siui
Dublin, CA, US - Received
- April 12, 2010
- Decision date
- June 8, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear Array cleared by the FDA?
Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear Array (K101008) received a 510(k) decision of Substantially Equivalent on June 8, 2010, 57 days after the submission was received.
What is the product code of K101008?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.