Radiology · 510(k) · 2025
Synapse PACS (7.5)
FUJIFILM Healthcare Americas Corporation. Cleared by FDA on 30 June 2025 under submission K243647, product code QIH (automated radiological image processing software). What FDA's record says, in FDA's words.
Device record · K243647
- Device. Synapse PACS (7.5)DEVICE
- Company. FUJIFILM Healthcare Americas CorporationCOMPANY
- Decision. 30 June 2025, 510(k), substantially equivalent (traditional review); received 26 November 2024DECISION
- Panel. RadiologyPANEL
- Product code. QIH, Automated Radiological Image Processing SoftwareCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (7 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.
FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. FUJIFILM Synapse PACS Software provides toolsets for: * Performing measurements on DICOM images * Regional segmentation * Importing and presenting data from modalities (DICOM and non-DICOM), * Solving clinical calculations * Creating and distributing structured reports FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. It enables the display, comparison, fusion, and volume rendering of studies to aid in reading, interpreting, reporting, and treatment planning. Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses, and clinicians. MIP, MPR Fusion, and volume rendering are not intended for mammography use. FUJIFILM Synapse PACS Software can be used to process FUJIFILM's DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA-cleared, DICOM compatible displays for mammography.
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 namedultrasound
- 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 FUJIFILM Healthcare Americas Corporation, 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.