COMPACT TOUCH Ophthalmic Ultrasound System
FDA 510(k) K180265 · Quantel Medical
510(k) numberK180265
Submission
- Device name
- COMPACT TOUCH Ophthalmic Ultrasound System
- Applicant
- Quantel Medical
Cournon D'Auvergne-Cedex, FR - Received
- January 31, 2018
- Decision date
- March 2, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was COMPACT TOUCH Ophthalmic Ultrasound System cleared by the FDA?
COMPACT TOUCH Ophthalmic Ultrasound System (K180265) received a 510(k) decision of Substantially Equivalent on March 2, 2018, 30 days after the submission was received.
What is the product code of K180265?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.