Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
K241582Canon Medical Systems Corporation · cleared 2024-09-12 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training. Validation of improved AI/ML based features:”
source quote (p.7)
“Auto Plane Detection, which introduces a deep learning method to the existing 2D Wall Motion Tracking (WMT) feature for the automatic selection of appropriate candidate cardiac views (A4C/A2C/A3C/SAX)”
source quote (p.7)
“The data used for the performance testing of these improved features was entirely independent and sequestered from the data used for training and was acquired from U.S. clinical patients with the predicate device, identical to the subject device in terms of data acquisition functionality.”
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 September 27, 2023, was included in this submission.”
Validation studies (4)
Retrospective clinical
n=239 patients · 1 site(s)
endpoints: more than 90% agreement for each of the four evaluated chamber views (A4C/A3C/A2C/SAX)
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), ISO 13485
Retrospective clinical
n=239 patients · 1 site(s)
endpoints: reduced operation time by Quick Strain with a significance level of 5%; all ICC(2,1) values by Quick Strain greater than 0.75; calculated NRMSE for EDV, ESV, EF and GLS by three clinical sonographers of less than 10%
Retrospective clinical
n=239 patients · 1 site(s)
endpoints: reduced operation time by Auto LVOT with a significance level of 5%; all ICC(2,1) values by Auto LVOT greater than 0.75; calculated NRMSE results by three clinical sonographers of less than 10%
Retrospective clinical
n=239 patients · 1 site(s)
endpoints: reduced operation time by Auto AoV with a significance level of 5%; all ICC(2,1) values by Auto AoV greater than 0.75; calculated Doppler trace measurement results by three clinical sonographers of less than 10%
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
- 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
- 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).