Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
K233195Canon Medical Systems Corporation · cleared 2024-01-24 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900,Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-A1700 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.”
source quote (p.3)
“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. The software features supported in the subject and predicate devices are identical except for the following new features and improvements to features or functionality available with the predicate devices: Left Atrial Appendage (LAA) Analysis, a new feature which enables the assessment of dimensions for certain user specified parameters, as well as provides a shape model of the left atrial appendage Strain Ratio Measurement, an improvement to existing strain elastography functionality which enables the calculation of strain ratio for strain elastography images Ultra Wideview Support for Mecha4D, an improvement to the existing Wideview feature, enabling its use with Mecha4D transducer model, PVT-675MVS CEUS viewer, an improvement to existing functionality which enables a viewer for stored contrast exam images”
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 02, 2014, is included in this submission.”
Validation studies (2)
Bench
sample size not stated
endpoints: equivalent measurement results as the existing manual measurements; calculate strain ratio equivalent to the known elasticity values; capability of the scan range for 4D mode to be increased; successful integration ... in accordance with requirements pre-specified by Olympus Medical Systems Corporation
standards: AAMI/ANSI 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=10 cases
endpoints: workflow improvements compared to existing manual workflow; ability of LAA Analysis to provide measurement results which are useful for the planning of transcatheter LAAO
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
- 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
- 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).