O-arm O2 Imaging System
K240465Medtronic Navigation, Inc · cleared 2024-06-21 · product code OWB · Radiology
Premarket evidence — what FDA accepted
source quote (p.8)
“Spine Smart Dose feature leverages Machine Learning technology with existing O-arm™ O2 images to achieve reduction in dose on the O-arm™ O2 Imaging System.”
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).”
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
Bench
sample size not stated
endpoints: metal artifact reduction; accuracy of the implant location
Retrospective clinical
n=45 other
endpoints: clinical utility
Bench
sample size not stated
endpoints: Image Quality (3D Line pair, Contrast, MTF and Geometric accuracy); Navigational accuracy
Reader study (MRMC)
sample size not stated
endpoints: safety and effectiveness for the intended users, uses, and use environments
standards: Applying Human Factors and Usability to Optimize Medical Device Design
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
- 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.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).