Who is the manufacturer of HYPER AiR?

Shanghai United Imaging Healthcare Co., Ltd. filed the 510(k) submission for HYPER AiR (K210001).

What is the FDA product code for HYPER AiR?

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for HYPER AiR?

510(k) clearance (submission type: Traditional).

Does HYPER AiR use AI or machine learning?

Yes. HYPER AiR (K210001) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like HYPER AiR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like HYPER AiR get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

HYPER AiR

K210001 · Shanghai United Imaging Healthcare Co., Ltd. · KPS · Apr 30, 2021 · Radiology

Device Facts

Record ID	K210001
Device Name	HYPER AiR
Applicant	Shanghai United Imaging Healthcare Co., Ltd.
Product Code	KPS · Radiology
Decision Date	Apr 30, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1200
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

HYPER AiR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.

Device Story

HYPER AiR is a software-only image reconstruction technique for PET/CT systems; it processes raw PET data to generate images with reduced noise and improved contrast. The device operates on the facility's existing PET/CT reconstruction computer (Windows-based) and serves as an alternative to standard OSEM reconstruction algorithms. It utilizes pre-trained convolutional neural networks (CNNs) integrated into the iterative reconstruction process to distinguish noise from image details. The software is used by radiologists and nuclear medicine physicians in clinical settings to assist in diagnostic image interpretation. By enhancing image quality, the device aims to support more accurate clinical decision-making. It is designed for implementation on previously cleared United Imaging PET/CT devices (uMI 550 and uMI 780).

Clinical Evidence

Clinical image evaluation performed by three board-certified nuclear medicine physicians comparing HYPER AiR to standard OSEM. Physicians assessed image contrast, noise, and overall quality. Results indicated HYPER AiR produced images with better contrast and lower noise than OSEM, with sufficient quality for clinical diagnosis. Bench testing used identical raw datasets from uMI 780 and uMI 550 to compare noise reduction, image contrast, and contrast-to-noise ratio (CNR) performance.

Technological Characteristics

Software-only image reconstruction algorithm. Operates on Windows-based PET/CT reconstruction computers. Utilizes convolutional neural networks (CNNs) integrated into an iterative OSEM reconstruction framework. Conforms to DICOM (NEMA PS 3.1-3.20), IEC 62304 (software life cycle), and ISO 14971 (risk management). Cybersecurity controls implemented per FDA guidance.

Indications for Use

Indicated for use by radiologists and nuclear medicine physicians to reduce noise and improve contrast in FDG PET images.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

uMI 550 (K193241)

Reference Devices

uMI 780 (K172143)

Related Devices

K193210 — HYPER DLR · Shanghai United Imaging Healthcare Co., Ltd. · Aug 4, 2020
K182336 — SubtlePET · Subtle Medical, Inc. · Nov 30, 2018
K210760 — Precise Image · Philips Medical Systems Nederland B.V. · Jan 14, 2022
K183460 — ClariCT.AI · Claripi, Inc. · Jun 13, 2019
K230807 — Deep Learning Image Reconstruction · Ge Healthcare Japan Corporation · Apr 20, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Shanghai United Imaging Healthcare Co., Ltd. % Xin GAO Regulatory Affairs Manager No. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA ### Re: K210001 Trade/Device Name: HYPER AiR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: March 27, 2021 Received: March 30, 2021 Dear Xin GAO: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for April 30, 2021 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210001 Device Name HYPER AiR Indications for Use (Describe) HYPER AiR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, which is divided into two halves by a horizontal line. The logo is simple and modern, and the use of bold font and a clean design gives it a professional look. ## 510 (k) SUMMARY #### 1. Date of Preparation March 26, 2021 #### 2. Sponsor Identification Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Contact Person: Xin GAO Position: Regulatory Affairs Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com #### 3. Identification of Proposed Device Trade Name: HYPER AiR Common Name: Emission Computed Tomography System Model(s): HYPER AiR Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS Review Panel: Radiology #### 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K193241 Device Name: Emission Computed Tomography System Model(s): uMI 550 Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology #### 5. Device Description: 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 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, with a white line running horizontally through the middle of the "U". The color of the text and the "U" shape is a dark gray. 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. #### 6. Indications for Use HYPER AiR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images. #### 7. Comparison of Technological Characteristics with the Predicate Devices A comparison between the technological characteristics of proposed and predicate devices is provided as below. | ITEM | Predicate Device uMI 550 ( K193241) | Proposed Device HYPER AIR | Remark | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Image Processing Location | Onsite on the facility PET/CT reconstruction computer. | Onsite on the facility PET/CT reconstruction computer. | Same | | Operating system | Windows | Windows | Same | | Workflow | Support online & offline | Support online & offline | Same | | Protocols | Standard scanner protocols | Standard scanner protocols | Same | | Algorithm | OSEM included in uMI 550 uses maximum- likelihood estimation techniques by maximizing the probability to the given counts represented by the image corresponding to the true activity distribution in the source, under a Poisson probability model for the positron emission. To accelerate convergence speed, it divides the projection data into a limited number of subsets and accesses them in order for iterative calculation. | HYPER AIR is a modification of conventional OSEM by incorporating the pre-trained convolutional neural networks into the iteration process. | OSEM included in uMI 550 uses maximum- likelihood estimation techniques. But HYPER AIR incorporates convolutional neural networks into OSEM to help to reconstruct PET images. 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. So HYPER AIR can produce lower noise and higher contrast PET images than OSEM. Performance Evaluation Report and Clinical Image | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which also resembles a shield with a horizontal line through the middle. The logo is simple and modern, with a focus on the company name and a unique visual element. | | | Evaluation show that it's safe and effective. | |--|--|-----------------------------------------------| |--|--|-----------------------------------------------| HYPER AiR utilizes the same hardware with the predicate devices and does not introduce any new restrictions on use. The differences do not affect the safety and the effectiveness. #### 8. Performance Data ### Non-Clinical Testing Non-clinical testing including image performance tests and clinical image evaluation were concluded for the HYPER AiR during the product development. UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance: ### Software - A NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine (DICOM) - > IEC 62304: Medical Device Software - software life cycle process - A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ## Other Standards and Guidance - > ISO 14971: Medical Devices - Application of risk management to medical devices - Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A ## Software Verification and Validation Software documentation for a Moderate Level of Concern software per FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission. The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence. 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. ## Performance Verification {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized symbol that resembles a "U" shape with a vertical line running through the center, creating a cross-like figure within the "U". Engineering bench testing was performed to support substantial equivalence and the product performance claims. The evaluation and analysis used the identical raw datasets obtained on UH's uMI 780 and uMI 550, and then applies both HYPER AiR and OSEM to do image reconstruction. The resultant images were then compared for: - > Performance on noise reduction - A Performance on image contrast - > Performance on contrast to noise ratio Performance tests have been conducted to show that HYPER AiR can improve image contrast while suppressing background noise. ### Clinical Image Evaluation The clinical image evaluation was performed by comparing HYPER AiR with OSEM. Each image was read by three board-certified nuclear medicine physicians who provided an assessment of image contrast, image noise and image quality. The results of the evaluation indicated that HYPER AiR produces images with better image contrast and lower image noise than OSEM while the image quality was sufficient for clinical diagnosis. #### 9. Conclusions Based on the comparison and analysis above, the proposed device has similar performance, equivalent safety and effectiveness as the predicate devices. The differences between the proposed device and predicate devices do not affect the indications for use, safety and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.