Ophthalmic · 510(k) · 2022
IDx-DR v2.3
Digital Diagnostics Inc.. Cleared by FDA on 17 June 2022 under submission K213037, product code PIB (diabetic retinopathy detection device). What FDA's record says, in FDA's words.
Device record · K213037
- Device. IDx-DR v2.3DEVICE
- Company. Digital Diagnostics Inc.COMPANY
- Decision. 17 June 2022, 510(k), substantially equivalent (traditional review); received 21 September 2021DECISION
- Panel. OphthalmicPANEL
- Product code. PIB, Diabetic Retinopathy Detection DeviceCODE
- Regulation. 21 CFR 886.1100, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
as those cleared under K203629. The major technological differences that exist between each component of the subject and predicate devices are described below. IDx-DR Service • Updated to look up the IDx-DR Analysis System version and sends it to IDx-DR Client for display on the user interface. IDx-DR Client • Updated to provide clear language of “exam completed” after repeated imaging attempts have resulted in an insufficient image quality output. The result output and report will remain unchanged, indicating exam quality was insufficient and a diagnostic result is not provided. • Updated to visually communicate image quality feedback by adding a green checkmark or a red “X” to images on the submission feedback screen. IDx-DR Analysis System • The image quality classifier of the subject device was replaced with a new image quality classifier. • Updated to improve the speed of the device. Table 1 provides a comparison between the technical characteristics and indications for use of the subject and predicate devices. Table 1: Comparison of the Subject and Predicate Device Subject Device IDx-DR v2.3
The product code's definition, from FDA's classification record. A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code PIB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
22 January 2025 · Injury · AEYE-DS RETINA SCREENING · AEYE HEALTH INC. · report MW5165159
I WITNESSED THE AEYE-DS SAMD SOFTWARE DIAGNOSE A PATIENTS RETINA IMAGE LEVERING IT'S AI(ARTIFICIAL INTELLIGENCE) TECHNOLOGY AND FAIL TO PROVIDE A COMPLETE DIAGNOSIS OF ISSUES PERTAINING TO THE PATIENT'S EYES. THE PATIENT HAD RETINA CONDITIONS THAT WOULD REQUIRE MEDICAL EVALUATIONS BASED ON RETINA CUPPING AND GLAUCOMA WITHOUT HAVING DIABETIC RETINOPATHY AND THE AEYE-DS SYSTEM DID NOT INFORM THE PATIENT OF THIS CONDITION OR REFER THE PATIENT TO ANOTHER SPECIALIST. IT ONLY STATED, "NEGATIVE FOR […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PIB, in Ophthalmic, from Digital Diagnostics Inc., or cleared in 2022. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.