HYPER DLR
K193210Shanghai United Imaging Healthcare Co., Ltd. · cleared 2020-08-04 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“HYPER DLR is a software-only device.”
source quote (p.5)
“HYPER DLR is an image post-processing technique which uses a pre-trained neural network to predict low noise PET image from high noise PET image. After training, the network could extract the noise component from the image, thus reducing the image noise. The software employs a convolutional neural network”
source quote (p.5)
“HYPER DLR is an image post-processing technique which uses a pre-trained neural network to predict low noise PET image from high noise PET image. After training, the network could extract the noise component from the image, thus reducing the image noise.”
source quote (p.7)
“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: Peak signal to noise ratio; Structural similarity index; Pearson correlation coefficient; Signal to noise ratio (SNR); Contrast to noise ratio (CNR); Normalized root mean square error; Bland-Altman plot of body & brain VOI SUVmean values
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, Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
Retrospective clinical
sample size not stated
endpoints: image noise; overall 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
- 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).