Butterfly iQ/iQ+ Ultrasound System
K220068Butterfly Network, Inc. · cleared 2023-03-31 · product code IYO · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The Butterfly iQ/Butterfly iQ+ Ultrasound System is a hand-held general-purpose diagnostic imaging system for use by trained healthcare professionals in environments where healthcare is provided to enable visualization and measurement of anatomical structures and fluid of adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected to a standard handheld commercial off the shelf (COTS) mobile device compatible with the Butterfly iQ/iQ+ mobile application (app). The subject device introduces the Auto B-line Counter, a software application backed by an image analysis algorithm.”
source quote (p.5)
“The subject device introduces the Auto B-line Counter, a software application backed by an image analysis algorithm.”
Validation studies (3)
Standalone
n=6,000 images · 253 site(s)
endpoints: non-inferiority to clinician annotators; intraclass correlation coefficient (ICC); Dice Coefficient Score (DSC)
Retrospective clinical
n=99 patients
endpoints: non-inferiority to clinician annotator ground truth; intraclass correlation coefficient (ICC); consistency across age, gender, and BMI subgroups
Bench
sample size not stated
endpoints: safety and effective performance; no additional risks
Reported performance (2 observations)
source quote (p.7)
“Performance was assessed by the widely accepted metrics, the intraclass correlation coefficient (ICC) between annotators for the Quality Indicator and Dice Coefficient Score (DSC), for the conformance of automatic B-line segmentation to ground truth.”
source quote (p.7)
“Performance was assessed by the widely accepted metrics, the intraclass correlation coefficient (ICC) between annotators for the Quality Indicator and Dice Coefficient Score (DSC), for the conformance of automatic B-line segmentation to ground truth.”
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) K232808 (decision 2024-01-04) from Butterfly Network, Inc. for a matching device line ("Butterfly iQ3 Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232808
- 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).