Velacur
K223287Sonic Incytes · cleared 2023-04-20 · product code IYO · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Velacur is a portable device intended to non-invasively measure the stiffness and attenuation of the liver via measurement of liver tissue shear modulus and ultrasound attenuation. This is done by measuring the wavelength or wave speed of mechanically created shear waves within the organ of the patient. Attenuation is measured directly via the loss in power of the ultrasound beam. The significant change was the addition two deep learning based algorithms.”
source quote (p.5)
“The significant change was the addition two deep learning based algorithms. The first being an organ/liver segmentation algorithm. The second algorithm changes the predicate's rules-based scan quality to a deep learning based shear wave quality algorithm.”
Validation studies (4)
Bench
sample size not stated
Bench
sample size not stated
standards: IEC 60601-1-2 Edition 4.0
Retrospective clinical
sample size not stated
Retrospective clinical
n=35 patients
endpoints: Dice Coefficient; pixel accuracy; sensitivity; specificity
Reported performance (5 observations)
source quote (p.6)
“For the Wave Quality Guide, the Dice Scores were 0.7 or higher and the sensitivity and specificity was 80% or greater.”
source quote (p.6)
“For the Wave Quality Guide, the Dice Scores were 0.7 or higher and the sensitivity and specificity was 80% or greater.”
source quote (p.6)
“For the Organ Segmentation Guide, the average Dice Score was greater than 0.7, and overall pixel based accuracy was greater than 80%.”
source quote (p.6)
“For the Organ Segmentation Guide, the average Dice Score was greater than 0.7, and overall pixel based accuracy was greater than 80%.”
source quote (p.6)
“For the Wave Quality Guide, the Dice Scores were 0.7 or higher and the sensitivity and specificity was 80% or greater.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233977 (decision 2024-09-04) from Sonic Incytes for a matching device line ("Velacur") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233977
- recall_reason_pattern
Software/algorithm-related recall in product code IYO (Civco Medical Instruments Co. Inc., initiated 2026-03-02): "There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98513
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).