Auto 3D Bladder Volume Tool
K200980Butterfly Network, Inc. · cleared 2020-06-11 · product code IYO · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The Butterfly Auto 3D Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.”
source quote (p.5)
“The Butterfly Auto 3D Bladder Volume Tool uses the machine learning-based algorithm, U-Net. The Auto 3D Bladder Volume Tool is based on the image segmentation method, U-Net¹, and the volume calculation is computed using the process of integration over binary images. 1. Ronneberger, Olaf, Fischer, Philipp, and Brox, Thomas. "U-net: Convolutional networks for biomedical image segmentation." International Conference on Medical image computing and computer-assisted intervention. Springer, Cham, 2015.”
source quote (p.8)
“Test datasets were strictly segregated from algorithm training datasets.”
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: Inter and intra-operator variability
Reported performance (1 observation)
source quote (p.7)
“0-100mL = ±7.5mL 100-740 mL = ±7.5%”
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 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).