TAVIPILOT
K243884Caranx Medical · cleared 2025-07-07 · product code OWB · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“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.”
source quote (p.6)
“TAVIPILOT utilizes trained AI/ML model to detect, track and mark the Non-coronary Cusp (NCC) and the transcatheter aortic valve (TAV) to guide the operator for precise positioning of the prosthetic valve, according to the planning phase.”
source quote (p.12)
“Cybersecurity documentation was provided as described in FDA guidance document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”
Validation studies (2)
Retrospective clinical
sample size not stated
endpoints: accuracy in detecting, tracking and marking of the NCC and the TAV.
Retrospective clinical
sample size not stated
endpoints: detecting, tracking and marking accuracy to ground truth.
Reported performance (3 observations)
source quote (p.11)
“The NCC was detected, tracked and marked ≤ 2 mm in 100% of all patients being tested with statistical significance.”
source quote (p.11)
“The TAV was detected, tracked and marked ≤ 1 mm in 100% of all patients being tested with statistical significance.”
source quote (p.11)
“The validation demonstrated that TAVIPILOT has equivalent or better detection, tracking, and marking of the NCC compared to the predicate device in all patients.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2026-05-20): "Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99079
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Medtronic Navigation, Inc.-Boxborough, initiated 2026-05-19): "Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99041
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2025-12-29): "Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be pr" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98244
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains i" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98096
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98108
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-08): "Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor," Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98071
- …and 1 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).