CoLumbo

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.

Columbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements: - Feature segmentation; - Feature measurement; - Threshold-based labeling of out-of-range measurement; and - Export of measurement results to a written report for user's review, revise and approval. Columbo does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for confirming/modifying settings, reviewing and verifying the software-generated measurements, inspecting out-of-range measurements, and approving draft report content using their medical judgment and discretion. The device is intended to be used only by hospitals and other medical institutions. Only DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are considered to be valid input. Columbo does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post-operational complications, tumors, infections.

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 namedMRI
• Mentionsdetection or identification of findings
• Mentionsmeasurement or quantification
• Mentionsa diagnostic claim
• Mentionsadult patients

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.

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