Radiology · 510(k) · 2026
AV Cardiac CT
Philips Medical Systems Nederland B.V.. Cleared by FDA on 5 March 2026 under submission K260169, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K260169
- Device. AV Cardiac CTDEVICE
- Company. Philips Medical Systems Nederland B.V. (NL)COMPANY
- Decision. 5 March 2026, 510(k), substantially equivalent (traditional review); received 20 January 2026DECISION
- Panel. RadiologyPANEL
- Product code. JAK, System, X-Ray, Tomography, ComputedCODE
- Regulation. 21 CFR 892.1750, Class IIREG
- Source. FDA database entry · decision document (12 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.
The AV Cardiac CT applications are intended to assist the user in viewing, processing, analysis of CT datasets and in preparation of cardiac interventions. The CT Coronary Analysis application is indicated to assist radiologists, cardiologists, and 3D technologists in the analysis of coronary artery anatomy for patients with suspected or diagnosed cardiac disease including coronary artery disease. The CT Functional Analysis application is indicated to assist radiologists, cardiologists, and 3D technologists in the analysis of heart anatomy and function, for patients with suspected or diagnosed cardiac diseases. Verification and Validation Software verification and validation activities were performed to verify that the software meets the product requirements. Verification Verification was performed according to the verification plan. Product requirement specifications were tested and found meeting the requirements. Validation Validation was performed according to the validation plan . User requirement specifications were tested and found meet ing the requirements. The validation results provide evidence that the product meets its intended use and user requirements.
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
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 5,281 reports filed against devices carrying product code JAK. 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:
25 September 2026 · Malfunction · REVOLUTION EVO · GE MEDICAL SYSTEMS, LLC · report 50896044
The GE CT table wouldn't move during stroke. Patient had to be physically moved to resume scan, delay in care. GE CT table has had the same issues with the table working intermittently x 3 weeks. Multiple techs have worked on it and the same problem persists.
25 September 2026 · Malfunction · Needle Guide · Quantum Surgical SAS · report 3023140882-2026-00002
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00087
It was reported that during the procedure, one locatable guide indicated as outside of the sensor sensing volume and another locatable guide had difficulty retracting from the extended working channel. The physician completed the superDimension portion of the case. No patient complications have been reported as a result of this event.
23 September 2026 · Other · NL4000 · Samsung HME America, Inc. · report 3004938766-2026-00043
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00088
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 JAK, in Radiology, from Philips Medical Systems Nederland B.V., or cleared in 2026. 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.