EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
K211597Philips Medical Systems · cleared 2021-09-08 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure software-only feature for use on the Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The Philips Auto Measure feature provides the end user with semi-automated functionality for a subset of 2D and Doppler measurements currently available on the Philips EPIQ and Affiniti systems when performing or reviewing an adult transthoracic echocardiography (TTE) with simultaneously acquired electrocardiogram (ECG). The AI/ML-enabled algorithm is designed to produce semi-automated and editable measures.”
source quote (p.8)
“With a machine learning algorithm, this feature allows the end user the enable semi-automated, editable measurements when performing an adult transthoracic echocardiogram in 2D and Doppler modes.”
Validation studies (1)
Bench
sample size not stated
endpoints: safe and effective performance; substantial equivalence; meets the defined requirements and performance claims
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. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- 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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97726
- 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 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).