uAngio AVIVA CX

K243376

Shanghai United Imaging Healthcare Co.,Ltd. · cleared 2025-04-28 · product code OWB · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The uAngio AVIVA CX is an angiographic X-ray system that generates X-rays through the X-ray tube, receives the signal through the flat panel detector and presents the image after D/A conversion and image post-processing. The main software characteristics of the uAngio AVIVA CX include patient registration, patient administration, 2D&3D image viewing and post-processing, data import/archiving, filming, camera-assisted recognition function (uSpace), and voice control function (uLingo).”
Algorithmmachine learning methods
source quote (p.11)
“uSpace uses multi-view cameras with machine learning methods and includes the following features: uLingo is based on a machine learning method and it allows the system to be controlled via user's voice command, such as protocol selection, image browsing, motion control, and tool utilization, to enhance the system's usability.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (8)

Bench

sample size not stated

endpoints: C-arm positioning accuracy; Imaging performance of CBCT (including in-plane uniformity, spatial resolution, reconstruction section thickness, noise, contrast to noise ratio, artifact analyses) can meet the requirements; Radiation dose can meet the requirements

standards: ANSI/AAMI ES60601-1:2005/A2:2021 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Amendment 2, ANSI/AAMI/IEC 60601-1-2:2014/A1:2021 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests - Amendment 1, IEC 60601-1-3:2021 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54:2022 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy, IEC 60601-2-43:2022 Medical Electrical Equipment - Part 2-43: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Interventional Procedures, IEC 60601-2-28:2017 Medical electrical equipment-Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis, IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements

Bench

n=3 other

endpoints: The accuracy of the Image Registration Algorithm can meet the requirement of mean target registration error (mTRE) less than the pixel diagonal distance.

Bench

n=2 other

endpoints: Dynamic range meets the submillimeter vessel simulation component is visible across all copper step wedges of the subtracted image.; Contrast sensitivity meets the low millimeter vascular simulation component should be visible in a copper step wedge of sufficient thickness in the subtraction image.

Bench

n=8 other

endpoints: The accuracy of neuro registration can meet a precision of at least 1 mm.

Bench

sample size not stated

endpoints: The accuracy of the Image Registration Algorithm in Stitching can meet the requirement of mean target registration error (mTRE) less than the pixel diagonal distance.

Bench

sample size not stated

endpoints: Test the performance of the human key point detection accuracy.; Test the performance of the collision detection rate.; The performance of the auto SID meets the distance maintenance accuracy.; And the adjustment of SID meets the requirements of radiation safety and image quality.

Bench

n=18 other

endpoints: Test the performance of wake-up algorithm.; Test the performance of voice commands recognition algorithm.

Retrospective clinical

sample size not stated

endpoints: Each image received a score of ≥ 3 and received a PASS result, indicating that image quality fulfills the need for diagnostic, intervention, and surgical procedures.

Reported performance (2 observations)

accuracyas written: “wake-up accuracy rate (SNR >= 15 dB(A))”0.95
source quote (p.16)
“When the environmental signal-to-noise ratio (SNR) is ≥15 dB(A), the wake-up accuracy rate reaches ≥95%;”
accuracyas written: “wake-up accuracy rate (SNR = 10 dB(A))”0.85
source quote (p.16)
“When environmental SNR is 10 dB(A), the wake-up accuracy rate reaches ≥85%.”

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 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.

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/K243376