O-arm O2 Imaging System

K240465

Medtronic Navigation, Inc · cleared 2024-06-21 · product code OWB · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The O-arm™ O2 Imaging System is a mobile x-ray system that provides 3D and 2D imaging. O-arm O2™ Imaging System was originally cleared for market under the original 510(k) K151000 and subsequently via special 510(k) K173664 and traditional 510(k) K200074. The device is classified under primary product code OWB (secondary product codes OXO, JAA) Regulation 21 CFR 892.1650. Spine Smart Dose feature leverages Machine Learning technology with existing O-arm™™ images to achieve reduction in dose on the O-arm™™ O2 Imaging System. It is an algorithm designed to reduce the noise of 3D reconstructions acquired from fewer acquisitions so that clinically viable 3D images can be produced using fewer projections.”
Algorithmmachine learning denoising algorithm
source quote (p.9)
“The Spine Smart Dose (SSD) feature uses a sparse image acquisition, an FDK reconstruction and a machine learning denoising algorithm to provide images of the spine at significantly lower dose (around 70% lower dose to patient).”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."”

Validation studies (8)

Retrospective clinical

n=100 images

endpoints: clinical equivalence

Bench

sample size not stated

endpoints: Image Quality (3D Line pair, Contrast, MTF, Uniformity and Geometric accuracy); Navigational accuracy

Retrospective clinical

n=40 images

endpoints: clinical equivalence; clinical utility scores

Bench

sample size not stated

endpoints: metal artifact reduction; accuracy of implant location

Retrospective clinical

n=45 other

endpoints: clinical utility scores; statistical equivalence

Bench

sample size not stated

endpoints: Image Quality (3D Line pair, Contrast, MTF and Geometric accuracy); Navigational accuracy

Bench

sample size not stated

endpoints: safety and effectiveness for intended users, uses, and use environments

Bench

sample size not stated

endpoints: dose accuracy (kV, mA, CTDI and DLP)

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 (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 matches this device's applicant.

    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 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 (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.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Medtronic Navigation, Inc.-Boxborough) — same firm and product code, not necessarily this device · initiated 2026-05-19

    Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

    recall event 99041 (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/K240465