Search Results

The Quantel Medical Aviso is intended to be used for:

• Axial Length measurement of the eye by ultrasonic means
• Implanted IOL power calculation, using the Axial Length measurement.
• Visualization of the interior of the eye and the orbit by A and B scans.

The intended use of the Aviso is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.

The intended use of the Aviso 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans.

The Quantel Medical Aviso 8 Mhz A-scan transducer is intended to be used with the Quantel Aviso A-scans of the eye and for biometric measurements.

The intended use of the Aviso B-HF B-scan transducer is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.

The Aviso is a combined ophthalmic A and B scan system that can also be used for biometric measurements of the eye and for IOL calculations.

The provided text is a 510(k) Summary for the Quantel Medical Inc. Aviso Ophthalmic A and B Scan Ultrasound System. It explicitly states in section (6) Performance Data, subsection (b) Clinical tests: "Since the Aviso uses the same technology as existing devices, clinical tests are not required."

Therefore, based on the provided document, there are no acceptance criteria or studies documenting performance against acceptance criteria because no clinical performance studies were conducted or required for this device to establish substantial equivalence. The submission relies on the device using the "same technology as existing devices" (predicate device K021683, Quantel Cinescan S) to demonstrate safety and efficacy.

As a result, I cannot provide the requested information regarding acceptance criteria and studies for the Aviso Ophthalmic A and B Scan Ultrasound System based solely on this document.

Ask a specific question about this device