Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

Validation studies (1)

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.

• recall_reason_pattern

  Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2026-05-20): "Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits." Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:99079

• recall_reason_pattern

  Software/algorithm-related recall in product code OWB (Medtronic Navigation, Inc.-Boxborough, initiated 2026-05-19): "Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware." Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:99041

• recall_reason_pattern

  Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2025-12-29): "Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be pr" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98244

• recall_reason_pattern

  Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains i" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98096

• recall_reason_pattern

  Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98108

• recall_reason_pattern

  Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-08): "Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor," Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98071

• …and 1 more.

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.

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-specific2022-09
  Computer-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-specific2022-09
  Clinical 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-specific2022-06
  Technical 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 guidance2026-01
  Clinical 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 guidance2026-01
  General 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 guidance2025-09
  Computer 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 guidance2025-06
  Cybersecurity 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 guidance2024-12
  Marketing 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 guidance2023-10
  Electronic 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 guidance2023-08
  Off-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 guidance2023-06
  Content 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 guidance2022-09
  Policy 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 guidance2021-10
  De 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 guidance2016-12
  Postmarket Management of Cybersecurity in Medical Devices

  Cybersecurity · Postmarket

• Final guidance2002-01
  General 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 guidance2025-01
  Artificial 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 guidance2024-08
  Predetermined 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 principles2024-06
  Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles

  Transparency · AI/ML lifecycle

• Guiding principles2023-10
  Predetermined 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 principles2021-10
  Good 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.