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 Diagnostic Ultrasound System 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”
Algorithmnew deep 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.”
PCCPNo
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: prespecified performance criteria; emphasizes the separation of adjacent blood flow

Retrospective clinical

n=3 patients

endpoints: prespecified performance criteria; emphasizes the separation of adjacent blood flow

Bench

sample size not stated

endpoints: prespecified performance criteria; Auto Tune performs as intended

Retrospective clinical

n=3 patients

endpoints: prespecified performance criteria; Auto Tune performs as intended

Retrospective clinical

sample size not stated

endpoints: improved visibility of tissue structure

Retrospective clinical

n=30 patients · 1 site(s)

endpoints: spatial resolution; contrast resolution; artifact suppression

Bench

sample size not stated

endpoints: lateral and axial resolution; slice resolution; contrast-to-noise ratio (CNR); reverberation artifact suppression; 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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
4
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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-03-06

    The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

    recall event 96538 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252074