Radiology · 510(k) · 2025
Hi-D Imaging 4TAVR
Hi-D Imaging AG. Cleared by FDA on 2 April 2025 under submission K241984, product code QIH (automated radiological image processing software). What FDA's record says, in FDA's words.
Device record · K241984
- Device. Hi-D Imaging 4TAVRDEVICE
- Company. Hi-D Imaging AG (CH)COMPANY
- Decision. 2 April 2025, 510(k), substantially equivalent (traditional review); received 8 July 2024DECISION
- Panel. RadiologyPANEL
- Product code. QIH, Automated Radiological Image Processing SoftwareCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (10 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.
[807.92(a)(5)] Hi-D Imaging 4TAVR is a software as a medical device (SaMD) intended to support trained healthcare professionals (cardiologists, radiologists, clinical specialists) with the assessment of the cardiovascular anatomy and visualization and measurement of structures of the heart and vessels, including the aortic valve, and with pre-operational planning and sizing for transcatheter aortic valve replacement (TAVR) procedures by providing: - Automatic segmentation of the full heart and vessels - 3D and 2D rendering of DICOM images - Automatic centerline detection - Automatic detection of the LVOT (left ventricular outflow tract), aortic, sinus, sinotubular junction (STJ), ascending aorta and descending aorta planes - Automatic multiplanar reconstruction (MPR) based on the centerline - Measurement and visualization tools - Manual measurement option for the user - Automatic S-curve extraction - Automatic report generation Hi-D Imaging 4TAVR software is indicated for patients with tricuspid aortic stenosis who are eligible for TAVR operations and without any prior aortic valve implants. C OMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)] The technological characteristics of the Hi-D Imaging 4TAVR software device are substantially equivalent to the predicate device, 3mensio Workstation (K153736). Table 1 lists the regulatory information and technological characteristics of the subject and predicate devices. Any differences between the […]
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.
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , 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
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 QIH, in Radiology, or cleared in 2025. 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.