Radiology · 510(k) · 2015
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC. Cleared by FDA on 27 February 2015 under submission K141922, product code NFJ (system, image management, ophthalmic). What FDA's record says, in FDA's words.
Device record · K141922
- Device. IRIS INTELLIGENT RETINAL IMAGING SYSTEMDEVICE
- Company. INTELLIGENT RETINAL IMAGING SYSTEMS, LLCCOMPANY
- Decision. 27 February 2015, 510(k), substantially equivalent (traditional review); received 16 July 2014DECISION
- Panel. RadiologyPANEL
- Product code. NFJ, System, Image Management, OphthalmicCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (7 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.
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.
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 48 reports filed against devices carrying product code NFJ. 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:
4 September 2026 · Injury · CALLISTO eye · Carl Zeiss Meditec AG (Oberkochen) · report 9615010-2026-00017
28 November 2022 · Injury · SYNERGY ODM · TOPCON HEALTHCARE SOLUTIONS, INC · report 3013986459-2022-00001
THE PATIENT UNDERWENT A CORRECTIVE SURGERY TO HAVE THEIR BILATERAL LENSES REPLACED WITH THOSE OF THE CORRECT PRESCRIPTION. THIS CORRECTIVE SURGERY OCCURRED THE DAY AFTER THE INITIAL INCIDENT, AND NO POST-OPERATION ISSUES HAVE BEEN REPORTED SINCE THEN.
14 April 2022 · Malfunction · CALLISTO EYE · CARL ZEISS MEDITEC AG · report 9615010-2022-00003
A HEALTHCARE PROFESSIONAL (HCP) REPORTED "DURING CATARACT SURGERY (1ST INTERVENTION), THE SURGEON'S FCP FUNCTION WAS NOT ACCORDING TO HIS USUAL SETTING: HE LOST THE FUNCTION XY. DURING THE SECOND INTERVENTION, AFTER A RESTART OF THE ARTEVO, HE LOST THE ZOOM AND FOCUS FUNCTION. THERE WAS A CASPULAR BAG RUPTURE DURING THIS SURGERY. THE SURGEON THINKS THAT THIS CONSEQUENCE IS LINKED TO THE DIFFERENT DEPROGRAMMINGS. THE SURGERY HAS BEEN COMPLETED BY THE USE OF ANOTHER MICROSCOPE AND AN IOL WAS […]
7 June 2021 · Injury · AL-SCAN VIEWER FOR NAVIS-EX · NIDEK CO., LTD. · report 8030392-2021-00002
ON MAY 20, 2021, NIDEK CO., LTD. RECEIVED AN INFORMATION FROM THE CUSTOMER TO REPORT THAT A LARGE POWER GAP HAD IN A PATIENT WHO USED AL-SCAN VIEWER (*1) TO CALCULATE IOL POWER. IT HAS ALREADY BEEN CONFIRMED THAT THE IOL POWER WAS CALCULATED BY SELECTING OTHER PATIENT DATA WITHOUT CHECKING MEASUREMENT DATA. OWING TO THE ABOVE PROCEDURE, THE PATIENT IN QUESTION WAS IMPLANTED WITH THE WRONG IOL POWER, RESULTING IN 5D OFF TARGET. CURRENTLY, IOL REPLACEMENT FOR THE PATIENT IN QUESTION HAS BEEN […]
22 February 2019 · Malfunction · MERGE EYE CARE PACS · MERGE HEALTHCARE · report 2183926-2019-00006
MERGE EYE CARE PACS IS INTENDED TO BE USED FOR VIEWING, COMMUNICATING AND STORING DIGITAL IMAGES DERIVED FROM AN IMAGE MODALITY. PACS FUNCTIONALITY INCLUDES, RECORDING, ANNOTATING, CALCULATIONS, PATIENT MEDICATION/INTERACTION INFORMATION, MONITORING & TOOLS TO MODIFY/ENHANCE IMAGE& DEMOGRAPHIC DATA. ON (B)(6) 2019, MERGE HEALTHCARE RECEIVED INFORMATION FROM AN ACCOUNT REGARDING INCORRECT INFORMATION PULLING INTO PATIENT'S RECORD. ACCORDING TO THE INFORMATION RECEIVED, AN EYE CARE PROFESSIONAL […]
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 NFJ, in Radiology, or cleared in 2015. 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.