C2-9-D Ultrasound Transducer
FDA 510(k) K122515 · GE Healthcare
510(k) numberK122515
Submission
- Device name
- C2-9-D Ultrasound Transducer
- Applicant
- GE Healthcare
Wauwatosa, WI, US - Received
- August 17, 2012
- Decision date
- September 11, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was C2-9-D Ultrasound Transducer cleared by the FDA?
C2-9-D Ultrasound Transducer (K122515) received a 510(k) decision of Substantially Equivalent on September 11, 2012, 25 days after the submission was received.
What is the product code of K122515?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.