AI-CVD

Retrieved 2026-10-29 · 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.

AI-CVD is an opportunistic AI-powered quantitative imaging tool that provides automated CT-derived anatomical and density-based measurements for clinician review. The device does not provide diagnostic interpretation or risk prediction. It is solely intended to aid physicians and other healthcare providers in determining whether additional diagnostic tests are appropriate for implementing preventive healthcare plans. AI-CVD has a modular structure where each module is intended to report quantitative imaging measurements for each specific component of the CT scan. AI-CVD quantitative imaging measurement modules include coronary artery calcium (CAC) score, aortic wall calcium score, aortic valve calcium score, mitral valve calcium score, cardiac chambers volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung density, liver density, bone mineral density, and muscle & fat composition. Using AI-CVD quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate patients who are unaware of their risk of coronary heart disease, heart failure, atrial fibrillation, stroke, osteoporosis, liver steatosis, diabetes, and other adverse health conditions that may warrant additional risk assessment, monitoring or follow- up. AI-CVD quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation. AI-CVD […]

The product code's definition, from FDA's classification record. To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

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 namedCT
• Mentionsan adjunct to the clinician, not a replacement
• Mentionsmeasurement or quantification
• Mentionsa diagnostic claim

Adverse-event reports in MAUDE, by product code

As of 2026-10-29, MAUDE held 10 reports filed against devices carrying product code QIH. 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:

2 July 2026 · Malfunction · SYNAPSE PACS · FUJIFILM HEALTHCARE AMERICAS CORPORATION · report 3004972322-2026-00002

ON 06/04/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A BUG IN SYNAPSE PACS V7.4.310 THAT COULD POTENTIALLY LEAD TO A MISDIAGNOSIS IN THE CARDIOLOGY BASED STUDIES. IT WAS FOUND DURING REGRESSION TESTING OF THE PRODUCT THAT THE ANNOTATION TAKEN AND SAVED IN AN EARLIER VERSION OF THE PRODUCT CAN SHOW THE INCORRECT VALUE IN BOTH ZERO VIEWER (ZV) AND VX WHEN REOPENING THE STUDY IN THE NEWER VERSION. THIS ISSUE WAS INTRODUCED INTO THE PRODUCT DURING AN ENHANCEMENT TO SUPPORT […]

9 April 2026 · Malfunction · ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT) · BRAINLAB SE · report 8043933-2026-00021

A PATIENT RECORD REQUIRED FOR STEREOTACTIC PLANNING COULD NOT BE FOUND DURING A FRAME-BASED STEREOTACTIC BIOPSY FOR A SUSPECTED BRAIN TUMOR. AFTER BRIEF TROUBLESHOOTING, IT BECAME CLEAR THAT THE PATIENT RECORD WAS UNINTENTIONALLY MERGED WITH ANOTHER PATIENT RECORD. THE SURGEON RESOLVED THE MERGE WITH SUPPORT FROM BRAINLAB. FURTHER INVESTIGATION BY BRAINLAB UNCOVERED FOUR MORE CASES OF INCORRECT PATIENT RECORD MERGES AT THE SAME SITE THAT WERE THEREAFTER RESOLVED. ACCORDING TO THE SURGEON […]

26 February 2026 · Malfunction · ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT) · BRAINLAB SE · report 8043933-2026-00011

WHILE SEARCHING FOR A MISSING PATIENT RECORD IN THE BRAINLAB PATIENT SELECTION 6.1 APPLICATION, A CUSTOMER DISCOVERED THAT THE MISSING PATIENT RECORD HAD BEEN MERGED WITH AN UNRELATED PATIENT RECORD. THE CUSTOMER RESTORED THE MERGED PATIENT RECORD TO ITS ORIGINAL CONSTITUENT PATIENT RECORDS ON THE SAME DAY. AFTER THIS, THE MISSING PATIENT RECORD BECAME AVAILABLE IN THE PATIENT LIST. ACCORDING TO THE HOSPITAL, NO PATIENT WAS AFFECTED DUE TO THE DESCRIBED ISSUE AS NEITHER OF THE PATIENTS HAS HAD […]

13 August 2025 · Malfunction · ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT) · BRAINLAB AG · report 8043933-2025-00058

A CUSTOMER REPORTED THAT A PATIENT RECORD DID NOT APPEAR IN THE BRAINLAB PATIENT SELECTION APPLICATION WHEN THE PATIENT'S NAME WAS SEARCHED. THE CUSTOMER FOUND THE MISSING PATIENT DATA MERGED INTO A DIFFERENT PATIENT RECORD AND WAS ABLE TO RESTORE THE PATIENT RECORDS TO THEIR ORIGINAL STATES. NO PATIENT WAS AFFECTED DUE TO THIS ISSUE.

25 June 2025 · Malfunction · SONIO DETECT · SONIO · report MW5171987

SONIO DETECT SOFTWARE AI ALGORITHM IS FAULTY AND WRONGLY LABELS FETAL STRUCTURES AND ASSOCIATES THEM WITH THE WRONG BODY PARTS. THE SYSTEM WILL FREQUENTLY DISPLAY AS VISUALIZED EVEN THOUGH IT HASN'T LEAVING PROVIDERS TO GIVE FALSE NORMALCY AND OPENING THEM UP TO LIABILITIES.

Where this fits

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