HYPER AiR

K210001

Shanghai United Imaging Healthcare Co.,Ltd. · cleared 2021-04-30 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“HYPER AiR is a software-only device.”

AlgorithmHYPER AiR is an image reconstruction technique which incorporates pre-trained neural networks in the iteration reconstruction process to control image noise and contrast. It is a modification of conventional OSEM by incorporating the pre-trained convolutional neural networks into the iteration process. Convolutional neural network is able to distinguish the noise component and the image details, and removes the noise component from the image or enhances the image details.

source quote (p.4)

“HYPER AiR is a software-only device. HYPER AiR is an image reconstruction technique which incorporates pre-trained neural networks in the iteration reconstruction process to control image noise and contrast. It is intended to be implemented on previously cleared PET/CT devices uMI 550 (K193241) and uMI 780 (K172143). HYPER AiR serves as an alternative to the existing image reconstruction algorithm that are available on the predicate devices. HYPER AiR is a modification of conventional OSEM by incorporating the pre-trained convolutional neural networks into the iteration process. Convolutional neural network is able to distinguish the noise component and the image details, and removes the noise component from the image or enhances the image details.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.6)

“UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” is included in this submission.”

Validation studies (2)

Bench

sample size not stated

endpoints: Performance on noise reduction; Performance on image contrast; Performance on contrast to noise ratio

standards: NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine (DICOM), IEC 62304: Medical Device Software - software life cycle process, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, ISO 14971: Medical Devices – Application of risk management to medical devices, Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation

Reader study (MRMC)

sample size not stated

endpoints: image contrast; image noise; image quality

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-72%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel, initiated 2025-12-24): "There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most eas" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98269
recall_reason_pattern
Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel, initiated 2025-06-20): "Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector mo" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97193
recall_reason_pattern
Software/algorithm-related recall in product code KPS (Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden, initiated 2024-10-31): "Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95673
recall_reason_pattern
Software/algorithm-related recall in product code KPS (Canon Medical System, USA, INC., initiated 2024-09-17): "When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95471

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).