IRIS INTELLIGENT RETINAL IMAGING SYSTEM
K141922INTELLIGENT RETINAL IMAGING SYSTEMS, LLC · cleared 2015-02-27 · product code NFJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data and images from computerized diagnostic instruments or systems. Original and color amplified images can be viewed by trained healthcare professionals. The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera, transmit the images up to a website and offer an opinion on the scans. All of the systems are software only; there are no hardware components.”
source quote (p.5)
“The application is fully HIPAA compliant encrypting all protected health information related to a patient's demographics using an encryption key stored separately from the database specific to each clinic utilizing the service.”
Validation studies (1)
Bench
sample size not stated
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code NFJ (MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany, initiated 2025-09-09): "Potential that the measured value may be smaller than the actual area." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97509
- recall_reason_pattern
Software/algorithm-related recall in product code NFJ (Topcon Medical Systems, Inc., initiated 2024-09-17): "The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95485
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).