Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System

K212704

Philips Medical Systems · cleared 2021-09-24 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesimd

source quote (p.6)

“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the following two new Liver Fat Quantification software features:”

AlgorithmAttenuation Quantification: a measure of the attenuation coefficient in dB/cm-MHz of a region of interest in the liver; Hepato-Renal Index (HRI) Quantification: a ratio measure of the echogenicity (‘brightness') of the liver parenchyma relative to that of the adjacent renal cortex

source quote (p.8)

“The Liver Fat Quantification software feature functionalities allow the end user to perform the following measurements during an ultrasound exam: (1) Attenuation Quantification: a measure of the attenuation coefficient in dB/cm-MHz of a region of interest in the liver (2) Hepato-Renal Index (HRI) Quantification: a ratio measure of the echogenicity (‘brightness') of the liver parenchyma relative to that of the adjacent renal cortex”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

standards: FDA's Guidance for Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005

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

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

drift signals on this device

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).