Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

K212333

Canon Medical Systems Corporation · cleared 2022-01-24 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The Aplio i900 Model TUS-A1900, Aplio i800 Model TUS-A1800 and Aplio i700 Model TUS-A1700, V6.5 are mobile diagnostic ultrasound systems.”

Algorithmartificial intelligence (AI) and/or machine learning (ML) of the automated initial contour tracing capability of 2D Wall Motion Tracking for left ventricle (2D WMT) and Auto Ejection Fraction for left ventricle (Auto EF)

source quote (p.6)

“The expansion of marketing language for several previously 510(k) cleared features is also proposed in the subject submission, including the promotion of the support by artificial intelligence (AI) and/or machine learning (ML) of the automated initial contour tracing capability of 2D Wall Motion Tracking for left ventricle (2D WMT) and Auto Ejection Fraction for left ventricle (Auto EF), marketed by Canon as 2D WMT with Full-assist function and Auto EF with Full-assist function, respectively.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.7)

“Additionally, cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 18, 2018, was included in this submission.”

Validation studies (1)

Bench

sample size not stated

standards: AAMI/ANSI ES60601-1:2012, IEC 60601-1-2 (2014), IEC 60601-2-37 (2015), IEC 62304 (2015), IEC 62359 (2017), ISO 10993-1 (2009)

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K252074 (decision 2025-10-31) from Canon Medical Systems Corporation for a matching device line ("Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252074
re_clearance
The FDA AI/ML device list shows a newer 510(k) K241582 (decision 2024-09-12) from Canon Medical Systems Corporation for a matching device line ("Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241582
re_clearance
The FDA AI/ML device list shows a newer 510(k) K233195 (decision 2024-01-24) from Canon Medical Systems Corporation for a matching device line ("Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233195
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
…and 1 more.

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).