Who is the manufacturer of ClariCT.AI?

Claripi, Inc. filed the 510(k) submission for ClariCT.AI (K212074).

What is the FDA product code for ClariCT.AI?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ClariCT.AI?

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

Does ClariCT.AI use AI or machine learning?

Yes. ClariCT.AI (K212074) 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 ClariCT.AI?

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 ClariCT.AI 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.

ClariCT.AI

K212074 · Claripi, Inc. · LLZ · Jul 27, 2021 · Radiology

Device Facts

Record ID	K212074
Device Name	ClariCT.AI
Applicant	Claripi, Inc.
Product Code	LLZ · Radiology
Decision Date	Jul 27, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

ClariCT.AI is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

Device Story

ClariCT.AI is a software-based image processing tool for CT DICOM images. It utilizes pre-trained deep learning models to perform noise reduction and image enhancement, improving quality for low-dose or non-diagnostic acquisitions. The device is used by radiologists and specialists in clinical environments. The subject device introduces an 'AI Marketplace Integration' module, allowing the denoising processor to be hosted via third-party AI marketplaces that integrate with existing PACS and IT infrastructure. It operates on Windows or Linux environments. By reducing noise, the device assists clinicians in interpreting images acquired at lower radiation doses, potentially benefiting patients by enabling diagnostic-quality imaging with reduced radiation exposure.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including system-level verification and validation, risk management, and compliance with DICOM standards (NEMA-PS 3.1-3.20) and FDA guidance for software and cybersecurity.

Technological Characteristics

Software-based image processing; utilizes pre-trained deep learning models for noise reduction. Compatible with DICOM format. Hardware requirements include PC with CUDA-supported graphics card. Deployment via Docker images in virtualized Linux environments or Windows. Complies with ISO 14971 (risk management) and NEMA-PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for radiologists and specialists requiring noise reduction and enhancement of CT images (head, chest, abdomen), particularly for low-dose or non-diagnostic images.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

ClariCT.AI (K183460)

Related Devices

K183460 — ClariCT.AI · Claripi, Inc. · Jun 13, 2019
K230807 — Deep Learning Image Reconstruction · Ge Healthcare Japan Corporation · Apr 20, 2023
K210760 — Precise Image · Philips Medical Systems Nederland B.V. · Jan 14, 2022
K161625 — PixelShine · Algomedica · Sep 19, 2016
K193073 — Deep Recon · Shanghai United Imaging Healthcare Co., Ltd. · Jul 6, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ July 27, 2021 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. ClariPi Inc. % Harry Park President ClariPi USA Inc. 1645 Park Creek Ct. ROCHESTER HILLS MI 48309 Re: K212074 Trade/Device Name: ClariCT.AI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 1, 2021 Received: July 2, 2021 Dear Harry Park: 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 mav, 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 avare 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 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-reporting {1}------------------------------------------------ combination-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) K212074 Device Name ClariCT.AI Indications for Use (Describe) ClariCT.AI is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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/0 description: The image shows the logo for "ClariPi", an AI medical imaging solutions company. The word "Clari" is in bold black font, while the "Pi" symbol is in blue. Below the company name, the words "AI MEDICAL IMAGING SOLUTIONS" are written in a smaller, non-bold font. # 510(k) Summary This 510(k) Summary is being submitted in accordance with the requirements of as required by section 807.92(c). #### . SUBMITTER ClariPi Inc. 3F, 70-15, Ihwajang-gil, Jongno-gu Seoul, Republic of Korea [03088] Tel: +82-2-741-3014 Fax: +82-2-743-3014 Email: claripi@claripi.com Contact person: Ms. Hyun-Sook Park, CEO Date Prepared: July 01, 2021 ### II. DEVICE Name of Device: ClariCT.Al Common or Usual Name: Picture, archive and communications system Classification Name: Medical Image Management and Processing System (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ ### III. PREDICATE DEVICE This predicate has not been subject to a design-related recall. The ClariCT.Al software device, addressed in this premarket notification, is substantially equivalent to the following commercially available software: | Device Classification Name | Medical Image Management and Processing System | |-----------------------------|-----------------------------------------------------------------------------------------| | 510(k) Number | K183460 | | Device Name | ClariCT.Al | | Applicant | ClariPi Inc. 3F, 70-15, Ihwajang-gil, Jongno-gu Seoul, Korea, Republic of [03088] | | Regulation Number | 892.2050 | | Classification Product Code | LLZ | | Date Received | 12/13/2018 | | Decision Date | 06/13/2019 | | 510k Review Panel | Radiology | ### IV. DEVICE DESCRIPTION ClariCT.AI software is intended for denoise processing and enhancement of CT DICOM images when higher image quality and/or lower dose acquisitions are desired. ClariCT.Al software can be used to reduce noises in CT images of the head, chest, and abdomen, in particular in CT images with a lower radiation dose. ClariCT.Al may also {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "Clariπ AI MEDICAL IMAGING SOLUTIONS". The word "Clari" is in bold black font, while the pi symbol is in blue. Below the word "Clariπ" is the text "AI MEDICAL IMAGING SOLUTIONS" in a smaller, thinner font. ## 510(k) Summary improve the image quality of low-dose nondiagnostic Filtered Back Projection images as well as Iterative Reconstruction images. The predicate device is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on-premise, and runs under the Microsoft Windows platform. The subject device, ClariCT.Al, added a new module (named Al Marketplace Integration module) to the original cleared device (K183460) to enable installation on the Al Marketplace system. The module integrates the Denoising Processor of the original device into the Al Marketplace system. So ClariCT.Al can be hosted through a third-party Al marketplace that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure. ### V. INDICATIONS FOR USE ClariCT.Al is a software device intended for networking, communication, processing, and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model. ### VI. SUBSTANTIAL EQUIVALENCE TABLE The following information compares the subject device to the predicate. The difference is that the subject device can be integrated into the Al Marketplace system that distributes Docker images in a virtual machine running in a Linux environment. It has no effect on the safety or efficacy of the subject device and does not raise any potential safety risks, and the subject device is identical in performance to the legally marketed device. | Item | Subject Device ClariCT.AI | Predicate Device ClariCT.AI (K183460) | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model. | ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model. | | Intended User | Radiologists and specialists | Radiologists and specialists | | Modality Support | CT | CT | | Noise Reduction Method | Noise reduction is performed with the use of pre-trained deep learning models. | Noise reduction is performed with the use of pre-trained deep learning models. | | Image Format | DICOM | DICOM | | Components And Hardware Requirement | Window Operating System, PC Hardware, CUDA supported graphics card or equivalent. | Window or Linux Operating System. PC Hardware supported graphics card or equivalent. | {5}------------------------------------------------ # 510(k) Summary Image /page/5/Picture/1 description: The image shows the logo for ClariPi, a company that provides AI medical imaging solutions. The logo consists of the word "Clari" in black font, followed by a blue pi symbol. Below the word "ClariPi" is the text "AI MEDICAL IMAGING SOLUTIONS" in a smaller black font. The logo is simple and modern, and it conveys the company's focus on artificial intelligence and medical imaging. ### VII. PERFORMANCE DATA Non-clinical performance testing has been performed on ClariCT.Al, (the subject device) and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document: - · ISO 14971 Medical devices Application of risk management to medical devices - · NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM) - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005. - · Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014. - · Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017. - The subject device was tested in accordance with the internal Verification and Validation processes of ClariPi Inc. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications, and the risk management results. The test results in this 510(k), demonstrate that ClariCT.Al: - · Complies with the aforementioned international and FDA-recognized consensus standards and - · FDA guidance document, and - · Meets the acceptance criteria and is adequate for its intended use. Therefore, ClariCT.Al, is substantially equivalent to the currently marketed predicate devices, in terms of safety and effectiveness. ### Clinical Testing: ClariCT.Al does not require clinical studies to demonstrate substantial equivalence to the predicate devices. ### VIII CONCLUSIONS Verification and Validation activities required to establish the safety and effectiveness of ClariCT.Al were performed. Testing involved system-level tests, performance tests, and safety tests from risk analysis. These tests demonstrated the subject device meets predefined functionality requirements. The subject device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. Test results with the substantial datasets demonstrate that the subject device is as safe and effective as the predicate devices. Therefore, the subject device is substantially equivalent to the predicate devices.