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The RetinaDx Angiography System is intended for use by trained medical professionals (physicians, ophthalmic technicians, ophthalmic photographers or others with similar training) in a medical office, hospital or other medical setting. It is indicated when a medical professional suspects a patient could have damage or disease of the retina. It is used to take photographs of the patient's retina, which are then studied by the medical professional to get additional information about the retina to consider in his or her efforts to decide on a diagnosis and treatment plan.

RetinaDx Digital Angiography System (Camera Ophthalmic)

This FDA document is a 510(k) clearance letter for the RetinaDx Digital Angiography System and does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on substantial equivalence to a predicate device, not necessarily on a new clinical study demonstrating specific performance against predefined acceptance criteria for a novel technology. Therefore, most of the information you requested would not be present in this type of FDA document.

To answer your questions, one would typically need access to the actual 510(k) submission, which is not publicly available in this detail, or a peer-reviewed publication of a clinical study for the device, which is not provided here.

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