Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

K252074

Canon Medical Systems Corporation · cleared 2025-10-31 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The Aplio i900 Model TUS-A1900, Aplio i800 Model TUS-A1800 and Aplio i700 Model TUS-A1700, V9.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz. (...) 3rd Harmonic Imaging (3-HI), a new deep learning (DL) enabled filtering process for images of the abdominal region, which enables higher spatial resolution, contrast resolution, and reduced artifacts”

Algorithmdeep learning (DL) enabled filtering process

source quote (p.7)

“3rd Harmonic Imaging (3-HI), a new deep learning (DL) enabled filtering process for images of the abdominal region, which enables higher spatial resolution, contrast resolution, and reduced artifacts”

Adaptive (vs locked)No

source quote (p.8)

“The algorithm was locked upon completion of development, prior to implementation into the 3-HI feature and no post-market, continuous learning capability is deployed on the subject device.”

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.7)

“Additionally, cybersecurity documentation, per the FDA guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", issued on June 27, 2025, was included in this submission.”

Validation studies (7)

Bench

sample size not stated

endpoints: demonstrate that the improved SMI Angio Mode performs as intended and emphasizes the separation of adjacent blood flow compared with the predicate function

standards: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012(Cons. Text) [Incl. AMD2:2021], IEC 60601-1-2 (2020), IEC 60601-2-37 (2015), IEC 62304 (2015), IEC 62359 (2017), ISO 10993-1 (2018)

Retrospective clinical

n=3 patients

endpoints: demonstrate that the improved SMI Angio Mode performs as intended and emphasizes the separation of adjacent blood flow compared with the predicate function

Bench

sample size not stated

endpoints: demonstrate that Auto Tune performs as intended

Retrospective clinical

n=3 patients

endpoints: demonstrate that Auto Tune performs as intended

Retrospective clinical

sample size not stated

endpoints: demonstrate improved visibility of tissue structure

Retrospective clinical

n=30 patients · 1 site(s)

endpoints: demonstrate improvement relative to predicate functionality (conventional 2nd harmonic imaging), with respect to spatial resolution, contrast resolution, and artifact suppression

Bench

n=5 other

endpoints: demonstrate the capability of 3-HI to visualize abdominal images better than conventional 2nd harmonic imaging with respect to lateral and axial resolution, slice resolution, CNR, reverberation artifact suppression and frequency spectra aspects of image quality

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).