Alturion Series Diagnostic Ultrasound System
K260667Philips Ultrasound, LLC · cleared 2026-06-29 · product code IYN · Radiology
FDA 510(k) summary for Alturion Series Diagnostic Ultrasound System (K260667)
Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.
- Validation studies
- 1
- Cited predicates
- 4
- Performance observations
- 0
- Product code
- IYN
Premarket evidence — what FDA accepted
source quote (p.6)
“The Philips Alturion Series Diagnostic Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its functions are to acquire ultrasound data and to display the data in various modes of operation. The system consists of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics, and the transducer connection points. In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls. The transducers connect to the system console and facilitate ultrasound scanning of patients. The Al Auto Measure Abdomen feature in the Alturion Series aims to improve workflow efficiency by automating selected measurements required for routine abdominal exams.”
source quote (p.6)
“The Al Auto Measure Abdomen feature in the Alturion Series aims to improve workflow efficiency by automating selected measurements required for routine abdominal exams. The Auto Measure Abdomen feature is designed to provide semi-automated and editable measures of abdominal organs such as kidney and spleen. The software feature offers to semi-automatically perform measurements for the user, who can always adjust caliper positions or make additional manual measurements.”
Validation studies (1)
Retrospective clinical
n=150 patients · 3 site(s)
endpoints: Bland-Altman Limits of Agreement; kidney sagittal length; kidney transverse width; kidney transverse height; spleen length
standards: IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2: 2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020, IEC 60601-2-37:2024, IEC 60601-2-18:2009, IEC 62304:2006+AMD1:2015, IEC 62359:2010+AMD1:2017, IEC 62366-1:2015+AMD1:2020, ISO 10993-1:2018, ISO 14971:2019
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
Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.
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.
- Final guidanceRadiology-specific2022-09Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
Radiology CADe/CADx · Software premarket content
Original July 2012; current database date reflects a Sept 2022 reissue. Governs CADe device 510(k) content.
- Final guidanceRadiology-specific2022-09Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
Radiology CADe/CADx
Original July 2012, revised 2020; current database date Sept 2022. Covers standalone and reader-study performance assessment for CADe.
- Final guidanceRadiology-specific2022-06Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
Quantitative imaging · Radiology CADe/CADx
Final (June 2022). Relevant to devices outputting quantitative imaging measurements.
- Final guidance2026-01Clinical Decision Support Software
Clinical decision support · SaMD (general)
New final guidance issued Jan 2026, superseding the Sept 2022 version; narrows the device-CDS scope. Applies to software that informs clinical management.
- Final guidance2026-01General Wellness: Policy for Low Risk Devices
SaMD (general) · Clinical decision support
Revised final (Jan 2026); now addresses noninvasive products estimating physiologic parameters (SpO2, BP, glucose). Reshapes the device / non-device line for AI wellness features.
- Final guidance2025-09Computer Software Assurance for Production and Quality Management System Software
SaMD (general) · Postmarket
Final (Sept 2025). Covers software used in production/QMS (incl. ML development-pipeline tooling), superseding Section 6 of the 2002 GPSV — not device software functions themselves.
- Final guidance2025-06Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
Cybersecurity · Software premarket content
Reissued June 2025 (retitled 'Quality Management System', was Sept 2023 'Quality System'); adds coverage of FD&C Act §524B cyber devices.
- Final guidance2024-12Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Predetermined Change Control Plan · AI/ML lifecycle · Software premarket content
Final (Dec 2024). Supersedes the April 2023 AI/ML PCCP draft.
- Final guidance2023-10Electronic Submission Template for Medical Device 510(k) Submissions
Software premarket content
eSTAR has been mandatory for 510(k)s since Oct 2023 — operationally unavoidable, though not AI-specific.
- Final guidance2023-08Off-The-Shelf Software Use in Medical Devices
Software premarket content · SaMD (general)
Final (Aug 2023). Applies when a device incorporates off-the-shelf software components (common in ML stacks).
- Final guidance2023-06Content of Premarket Submissions for Device Software Functions
Software premarket content · SaMD (general)
Final (June 2023); replaced the May 2005 'Software Contained in Medical Devices' guidance. Documentation level drives the software content of the submission.
- Final guidance2022-09Policy for Device Software Functions and Mobile Medical Applications
SaMD (general) · Clinical decision support
Current version Sept 2022. Frames which software functions FDA regulates as devices.
- Final guidance2021-10De Novo Classification Process (Evaluation of Automatic Class III Designation)
De Novo pathway
Final (Oct 2021), issued with the De Novo final rule. Most relevant to first-of-a-kind devices without a predicate (DEN-numbered clearances).
- Final guidance2016-12Postmarket Management of Cybersecurity in Medical Devices
Cybersecurity · Postmarket
- Final guidance2002-01General Principles of Software Validation
SaMD (general) · Software premarket content
Still active except Section 6 (superseded Sept 2025 by the Computer Software Assurance final guidance).
- Draft guidance2025-01Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
AI/ML lifecycle · Software premarket content · Transparency
Draft as of July 2026 (published Jan 2025); finalization is on CDRH's FY2026 agenda but not yet published. Treat as FDA's stated direction, not a binding expectation.
- Draft guidance2024-08Predetermined Change Control Plans for Medical Devices
Predetermined Change Control Plan · Postmarket
Draft (Aug 2024) extending PCCPs beyond AI to all devices under FD&C §515C; not final as of July 2026.
- Guiding principles2024-06Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
Transparency · AI/ML lifecycle
- Guiding principles2023-10Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
Predetermined Change Control Plan · AI/ML lifecycle
FDA/Health Canada/MHRA joint principles (Oct 2023); companion to the GMLP and Transparency principles.
- Guiding principles2021-10Good Machine Learning Practice for Medical Device Development: Guiding Principles
AI/ML lifecycle · SaMD (general)
FDA/Health Canada/MHRA joint principles (Oct 2021). Foundational, not a binding guidance; IMDRF issued a related GMLP document Jan 2025.
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.
Related FDA clearances
More AI/ML devices under product code IYN
These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.
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EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
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Sonio Detect (v3)
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LOGIQ Totus
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LOGIQ Fortis
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HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
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cleared 2026-01-05