Butterfly Gestational Age Tool
K252148Butterfly Network, Inc. · cleared 2026-03-27 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Butterfly Gestational Age Tool (GA Tool) is a software application that guides trained healthcare professionals through measuring fundal height and obtaining ultrasound cines of a patient's gravid abdomen, using a Butterfly ultrasound probe (iQ+ or iQ3) connected to a tablet. Users launch the tool as a calculation tool within the iQ App's OB scan presets (OB 1/GYN or OB 2/3). ... The collected sweeps are input into a deep-learning model within the GA Tool. The model then outputs an estimated gestational age.”
source quote (p.6)
“The collected sweeps are input into a deep-learning model within the GA Tool. The model then outputs an estimated gestational age. ... The Butterfly GA tool uses Deep Learning (DL)”
source quote (p.7)
“Similarly, since there are no changes to the general Butterfly platform, there is no impact to cybersecurity requirements.”
Validation studies (2)
Retrospective clinical
n=1,000 patients · 2 site(s)
endpoints: mean absolute error (MAE)
Prospective clinical
n=111 patients · 4 site(s)
endpoints: Butterfly GA Tool error in reference to the Gestational Age calculation from Last Menstrual Period (LMP); Bland-Altman bias; Limits of Agreement (LOA)
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97843
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97726
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96992
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95254
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).