Radiology · 510(k) · 2025
TAVIPILOT
Caranx Medical. Cleared by FDA on 7 July 2025 under submission K243884, product code OWB (interventional fluoroscopic x-ray system). What FDA's record says, in FDA's words.
Device record · K243884
- Device. TAVIPILOTDEVICE
- Company. Caranx Medical (FR)COMPANY
- Decision. 7 July 2025, 510(k), substantially equivalent (traditional review); received 18 December 2024DECISION
- Panel. RadiologyPANEL
- Product code. OWB, Interventional Fluoroscopic X-Ray SystemCODE
- Regulation. 21 CFR 892.1650, 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.
TAVIPILOT is an intra-operative software which provides real-time fluoroscopy detection, tracking and marking of the Non-Coronary Cusp and the prosthetic valve, to allow optimal guidance for precise positioning of the prosthetic valve, according to the planning phase, for TAVI/TAVR (transcatheter aortic valve implantation/replacement) procedures. The guidance provided by TAVIPILOT is not intended to substitute the cardiac surgeon’s or the interventional cardiologist’s judgment and analysis of the patient’s condition. The device is only intended for adults (i.e., 21 years and older). Contra-indications: - Patients who have already undergone a TAVI/TAVR or SAVR (surgical aortic valve replacement) - Patients diagnosed with aortic insufficiency - Patients for whom the main access for the TAVI/TAVR catheter is not femoral - Patients who have a non-tricuspid native valve - Patients who have a permanent Pacemaker implant or temporary Pacemaker within 2 cm from the aortic root, other than the pacing guidewire - Patients who have thoracic surgical implants - Patients who are not adults
The product code's definition, from FDA's classification record. Interventional fluoroscopy
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
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 50,680 reports filed against devices carrying product code OWB. 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:
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002661
It was reported to Philips that the system was unable to start up properly.The system was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002659
It was reported to Philips that the system was experiencing booting issues.The system was not in clinical use during the event. No harm was reported to the user or the patient during the event.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002662
It was reported to Philips that the system was unable to perform exposure.The system was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD20 · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002664
It was reported to Philips that the system's propellor geometry movement was not available.The device was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002665
It was reported to Philips that the system could not emit X-ray.The device was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
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 OWB, 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.