O-arm O2 Imaging System

K240465

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

FDA 510(k) summary for O-arm O2 Imaging System (K240465)

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
8
Cited predicates
1
Performance observations
0
Product code
OWB
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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

25
recalls in product code, 24mo
10707
MAUDE reports in code, 12mo
+35%
vs code's own 3-yr baseline
10
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 (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2026-07-16): "Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropr" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:99422

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2026-07-16): "Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications an" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:99423

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2026-06-29): "Firmware issue potentially leading to loss of geometry movements." Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:99378

  • 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

  • …and 4 more.

Recalls attributed to this device

  • Recall record explicitly lists K240465 · Medtronic Navigation, Inc.-Boxborough · initiated 2026-05-19 · Open, Classified

    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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code OWB

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Trinias

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cleared 2026-03-10

CARA System

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cleared 2026-02-20

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

K251602

Canon Medical Systems Corporation

cleared 2025-10-10

LUMINOS Q.namix T; LUMINOS Q.namix R

K250660

Siemens Medical Solutions

cleared 2025-07-14

TAVIPILOT

K243884

Caranx Medical

cleared 2025-07-07

uAngio AVIVA CX

K243376

Shanghai United Imaging Healthcare Co.,Ltd.

cleared 2025-04-28

3DXR

K243446

GE Medical Systems SCS

cleared 2025-02-25

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K240465