Radiology · 510(k) · 2025
Cleerly LABS (v2.0)
Cleerly, Inc.. Cleared by FDA on 7 March 2025 under submission K242338, product code QIH (automated radiological image processing software). What FDA's record says, in FDA's words.
Device record · K242338
- Device. Cleerly LABS (v2.0)DEVICE
- Company. Cleerly, Inc.COMPANY
- Decision. 7 March 2025, 510(k), substantially equivalent (special review); received 7 August 2024DECISION
- Panel. RadiologyPANEL
- Product code. QIH, Automated Radiological Image Processing SoftwareCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (9 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.
Cleerly LABS is a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e. atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.
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
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, from Cleerly, Inc., 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.