Aviso Ophthalmic Ultrasound System
FDA 510(k) K051851 · Quantel Medical
510(k) numberK051851
Submission
- Device name
- Aviso Ophthalmic Ultrasound System
- Applicant
- Quantel Medical
Hasbrouck Heights, NJ, US - Received
- July 8, 2005
- Decision date
- August 3, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aviso Ophthalmic Ultrasound System cleared by the FDA?
Aviso Ophthalmic Ultrasound System (K051851) received a 510(k) decision of Substantially Equivalent on August 3, 2005, 26 days after the submission was received.
What is the product code of K051851?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.