LUMINOS Q.namix T; LUMINOS Q.namix R

K250660

Siemens Medical Solutions · cleared 2025-07-14 · product code OWB · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.7)
“LUMINOS Q.namix T and LUMINOS Q.namix R are a devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics.”
AlgorithmAI-based Auto Cropping, Auto Thorax, Auto Long-Leg/Full-Spine collimation
source quote (p.9)
“AI-based Auto Cropping”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.17)
“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission - Guidance for Industry and Food and Drug Administration Staff Document Issued on September 27, 2023”

Validation studies (2)

Reader study (MRMC)

sample size not stated · 4 site(s)

endpoints: images are acceptable for diagnostic in radiography & fluoroscopy

standards: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, ANSI AAMI 60601-1, 2020 Ed. 3.2, IEC 60601-1-2 2020 Ed 4.1, IEC 60601-1-3: Edition 2.2, 2021, IEC 60601-2-28, 2017, IEC 60601-2-54 2018, Edition 1.2, IEC 60601-1-6 2020 Ed 3.2, IEC 62366-1 2020 Ed 1.1, ISO 14971: 2019, IEC 62304 2015, Ed.1.1, IEC 61910-1: 2014, Ed 1.0, NEMA PS 3.1 - 3.20 2023e, ISO EN ISO 10993-1 Fifth edition 2018

Reader study (MRMC)

sample size not stated

endpoints: images and fluorography studies with this detector were qualified for proper diagnosis

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

100
recalls in product code, 24mo
10937
MAUDE reports in code, 12mo
+44%
vs code's own 3-yr baseline
7
drift signals on this device
  • 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 matches this device's applicant.

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

  • 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 matches this device's applicant.

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

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2025-12-05): "A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .Whe" Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:98230

  • 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 (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

  • …and 1 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2026-06-08

    Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

    recall event 99224 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2026-05-20

    Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

    recall event 99079 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2026-05-20

    Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

    recall event 99079 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2026-05-20

    Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

    recall event 99079 (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/K250660