CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System
FDA 510(k) K061488 · Shantou Institute of Ultrasonic Instruments (Siui
510(k) numberK061488
Submission
- Device name
- CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System
- Applicant
- Shantou Institute of Ultrasonic Instruments (Siui
Dublin, CA, US - Received
- May 31, 2006
- Decision date
- June 30, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System cleared by the FDA?
CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System (K061488) received a 510(k) decision of Substantially Equivalent on June 30, 2006, 30 days after the submission was received.
What is the product code of K061488?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.