uAngio AVIVA CX
K243376Shanghai United Imaging Healthcare Co.,Ltd. · cleared 2025-04-28 · product code OWB · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“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). ... 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.”
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.”
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
sample size not stated
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
sample size not stated
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
sample size not stated
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.; The stitching results meet the clinical needs, with an average score from clinical specialists higher than 2.
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: spatial detail; contrast-noise performance; clinical motion; clinical features of interest
Reported performance (2 observations)
source quote (p.16)
“When the environmental signal-to-noise ratio (SNR) is ≥15 dB(A), the wake-up accuracy rate reaches ≥95%;”
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
- 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). 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).