Radiology · 510(k) · 2023
VisiRad XR
Imidex Inc.. Cleared by FDA on 3 August 2023 under submission K223133, product code MYN (analyzer, medical image). What FDA's record says, in FDA's words.
Device record · K223133
- Device. VisiRad XRDEVICE
- Company. Imidex Inc.COMPANY
- Decision. 3 August 2023, 510(k), substantially equivalent (traditional review); received 3 October 2022DECISION
- Panel. RadiologyPANEL
- Product code. MYN, Analyzer, Medical ImageCODE
- Regulation. 21 CFR 892.2070, Class IIREG
- Source. FDA database entry · decision document (8 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.
VisiRad XR is a computer-aided detection (CADe) device intended to identify and mark regions of interest that may be suspicious for lung nodules and masses on chest radiographs. It identifies features associated with pulmonary nodules and masses from 6-60mm in size. Detection of suspicious findings by VisiRad XR is intended as an aid only after the physician has performed an initial interpretation; it is not intended to replace the review by a qualified radiologist and is not intended to be used for triage or to make or confirm a diagnosis. The intended patient population for VisiRad XR consists of patients >21 years of age on whom chest radiographs have been acquired in an outpatient or emergency department setting.
The product code's definition, from FDA's classification record. For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
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.
- Modalities namedradiographs (X-ray)
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 5 reports filed against devices carrying product code MYN. 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:
13 March 2025 · Injury · SECOND OPINION · PEARL INC. · report MW5167620
DEAR FDA MEDWATCH, I AM REPORTING A SERIOUS ISSUE REGARDING PLANET DDS'S INTEGRATION OF PEARL AI ASSIST IN DENTICON PMS AND XVWEB IMAGING SYSTEM, WHICH LED TO AN INACCURATE TREATMENT RECOMMENDATION AND INABILITY TO CORRECT AI FINDINGS. WHAT HAPPENED I RECENTLY VISITED A DENTAL CLINIC THAT USES DENTICON PMS WITH PEARL AI ASSIST. BEFORE REVIEWING MY DENTAL IMAGES, THE DENTIST RECOMMENDED AN ENDODONTIC PROCEDURE BASED ON AI FINDINGS DISPLAYED IN DENTICON. AI SUGGESTED DECAY AND A PERIAPICAL […]
18 February 2025 · Malfunction · OVERJET CARIES ASSIST · OVERJET · report MW5166306
THE 510(K) SUBSTANTIAL EQUIVALENCE REPORT FOR OVERJET CARIES ASSIST (K212519) SHOWS SENSITIVITY AND SPECIFICITY OF 72.0% AND 98.1%, RESPECTIVELY, FOR CARIES DETECTION. HOWEVER, CALCULATIONS BASED ON THE TABLE IN SECTION 10 REVEAL A POSITIVE PREDICTIVE VALUE OF ONLY 57.2%. THIS MEANS THAT 42.8% OF OBSERVED CARIES BY THE OVERJET PRODUCT WERE NOT ACTUALLY CARIES ACCORDING TO GROUND TRUTH. SUCH A HIGH RATE OF FALSE POSITIVES HAS THE POTENTIAL TO RESULT IN OVER-TREATMENT DUE TO FALSELY IDENTIFYING […]
15 April 2024 · Malfunction · PEARL SECOND OPINION · PEARL INC. · report MW5153880
HELLO, I AM WRITING TO EXPRESS SIGNIFICANT CONCERNS REGARDING THE COMPLIANCE AND MARKETING PRACTICES OF PEARL, PARTICULARLY RELATED TO THEIR DENTAL DIAGNOSTIC TOOLS. OUR EXPECTATIONS WERE THAT PEARL'S FDA CLEARED MEDICAL DEVICE ((B)(6)) WOULD ADHERE TO THE HIGHEST STANDARDS OF REGULATORY COMPLIANCE, ESPECIALLY GIVEN THE CRITICAL NATURE OF DENTAL HEALTH DIAGNOSTICS. HOWEVER, IT APPEARS THERE ARE CRUCIAL AREAS WHERE PEARL'S OFFERINGS MAY NOT ALIGN WITH REGULATORY GUIDELINES AND DO NOT ALIGN WITH […]
11 January 2018 · Malfunction · POWERLOOK AMP WITH SECONDLOOK DIGITAL GE · ICAD, INCORPORATED · report 1225671-2018-00001
A CUSTOMER SITE INDICATED THAT NO CAD MARKINGS WERE REPORTED FROM THE CAD AFTER PROCESSING PATIENT IMAGES. THE OEM MAMMOGRAPHY FIELD SERVICE ENGINEER (FSE) DID NOT APPLY THE CAD LICENSE AFTER INSTALLING THE CAD SOFTWARE. THIS RESULTED IN THE SITE NOT HAVING CAD MARKS ON CASES FOR SOME TIME. NO PATIENT INJURY OR ADVERSE EVENT WAS ASSOCIATED WITH THIS INCIDENT.
18 May 2006 · Malfunction · RAPIDSCREEN RS-2000D AND RS-DIGITAL · RIVERAIN MEDICAL · report 3005156333-2006-00001
ON APRIL 24, 2006, A CONTROL FILE ERROR WITH RESPECT TO THE RAPIDSCREEN RS-2000D AND RS-DIGITAL DEVICE WAS DISCOVERED DURING A CLINICAL STUDY BEING CONDUCTED FOR A PMA SUPPLEMENTAL SUBMISSION. THE CONTROL FILE ERROR RESULTS IN SENSITIVITY AND SPECIFICITY THAT DIFFER FROM THE PMA-APPROVED PRODUCT SPECIFICATIONS FOR THE DEVICE. SPECIFICALLY, THE PRODUCT THAT WAS PLACED INTO COMMERCIAL DISTRIBUTION HAS A SENSITIVITY OF 57% AND A SPECIFICITY OF 3.97 (FALSE POSITIVES PER IMAGE), WHICH DIFFERS FROM […]
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 MYN, in Radiology, or cleared in 2023. 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.