Who is the manufacturer of UltraLinq?

Ultralinq Healthcare Solutions, Inc. filed the 510(k) submission for UltraLinq (K143176).

What is the FDA product code for UltraLinq?

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

What is the regulatory pathway for UltraLinq?

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

Does UltraLinq use AI or machine learning?

Yes. UltraLinq (K143176) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for UltraLinq?

ASTRA (K111694); LVivo EF Software Application (K130779).

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

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 UltraLinq 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.

UltraLinq

K143176 · Ultralinq Healthcare Solutions, Inc. · LLZ · Jul 17, 2015 · Radiology

Device Facts

Record ID	K143176
Device Name	UltraLinq
Applicant	Ultralinq Healthcare Solutions, Inc.
Product Code	LLZ · Radiology
Decision Date	Jul 17, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Left ventricular wall detection and measurement	—	—	—	—	—	—	—

Indications for Use

UltraLinq is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation. Diagnosis is not performed by the software but by qualified Physicians.

Device Story

UltraLinq is a web-based PACS software application for receiving, processing, reviewing, displaying, and archiving medical images/data from modalities like Ultrasound and MR. It operates on web-enabled computers, iPads, and iPhones. Physicians and trained staff use the system to share, review, download, and route studies, or send them to EMR/EHR systems. Mobile access is for non-diagnostic viewing and referral. The device integrates the LVivo EF algorithm to perform non-invasive, automated detection and measurement of the left ventricular wall from echocardiographic videos to calculate ejection fraction, assisting clinicians in cardiac evaluation. Diagnosis remains the responsibility of the qualified physician. The system supports standard DICOM interoperability.

Clinical Evidence

No new clinical data was generated for this submission. The device integrates the LVivo EF algorithm without modification; clinical performance for the automated ejection fraction calculation relies on the clinical study previously submitted and cleared under DiACardio's LVivo EF Software Application (K130779). Bench testing and software validation were performed to confirm system requirements and specifications.

Technological Characteristics

Web-based software application; operates on off-the-shelf hardware (PC, iPad, iPhone). Conforms to ACR/NEMA DICOM 3.0 standards for interoperability. Features include image storage, retrieval, processing (zoom, brightness, contrast, window-level, panning), and automated echocardiographic analysis. Software is classified as moderate concern. Cloud-based computing and storage architecture.

Indications for Use

Indicated for trained medical professionals (physicians, radiologists, nurses, technicians) to receive, process, review, display, and archive medical images (e.g., Ultrasound, MR) across computer systems and mobile devices. Includes non-invasive processing of echocardiographic images for left ventricular wall detection and function evaluation (workstation only). Not for mammography.

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

ASTRA (K111694)
LVivo EF Software Application (K130779)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ULTRALINQ HEALTHCARE SOLUTIONS, INC. % Ms. Rita King CEO MethodSense. Inc. PO Box 110352 DURHAM NC 27709 Re: K143176 Trade/Device Name: UltraLing Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 15, 2015 Received: June 17, 2015 Dear Ms. King: 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. July 17, 2015 {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert A Ochs Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K143176 Device Name UltraLinq #### Indications for Use (Describe) UltraLinq is a software imagement system intended to receive, process, review, display, and archive medical images and data from imaging modalities (e.g. Ultrasound (US), and Magnetic Resonance (MR)). Images and data can be stored, communicated and displayed across computer systems and mobile devices. UltraLinq is a single system that can run on a web-enabled computer, iPad and iPhone and may be interfaced with other PACS systems. Diagnosis is not performed by the software but by qualified Physicians. Typical users of this system are trained and qualified professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. UltraLinq is used to: - · share reports and studies with other UltraLinq users, - · review reports and studies, - · download and save reports and studies, - · send reports and studies to EMR and EHR systems, and - · route reports and studies to other UltraLinq users. UltraLinq provides access to medical images on mobile devices for non-diagnostic viewing and referral purposes. The mobile device access functionality is used for patient management by the medical community in order to access and display patient data, medical reports, and medical images. Mobile devices are not intended to replace full diagnostic workstations and should be used only when there is no access to a workstation. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in cardiac evaluation. This device is not to be used for mammography. Additional Information (AI) to 510(k) - K143176 | 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 | | <a href="mailto:PRAStaff@fda.hhs.gov">PRAStaff@fda.hhs.gov</a> | "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}------------------------------------------------ ### 510(k) Summary ### UltraLinq K143176 This 510(k) Summary is in conformance with 21CFR 807.92 | Submitter: | UltraLinq Healthcare Solutions, Inc. 236 West 30th Street, 6th Floor New York, NY 10001 Phone: 646-666-9576 | |------------|----------------------------------------------------------------------------------------------------------------------| |------------|----------------------------------------------------------------------------------------------------------------------| - Primary Contact: Rita King, CEO MethodSense, Inc. Email: ritaking@methodsense.com Phone: 919-313-3961 Fax: 919-313-3979 - Company Contact: Stephen Farber Chief Executive Officer - Date Prepared: June 15, 2015 #### Device Name and Classification | Trade Name: | UltraLinq | |-----------------------|---------------------------------------------------------------| | Common Name: | Picture Archiving Communications System (PACS) | | Classification: | Class II | | Regulation Number: | 892.2050 – Picture Archiving and Communications System (PACS) | | Classification Panel: | Radiology | | Product Code: | LLZ | ## Predicate Devices: | | Primary Predicate | Secondary Predicate | |---------------------------|-----------------------------------------|-------------------------------| | Trade Name | ASTRA | LVivo EF Software Application | | Common Name | Picture Archiving Communications System | Picture Archiving Device | | 510(k) Submitter / Holder | Candelis, Inc. | DiACardio, Ltd. | | 510(k) Number | K111694 | K130779 | | Regulation Number | 892.2050 | 892.2050 | | Classification Panel | Radiology | Radiology | | Product Code | LLZ | LLZ | {4}------------------------------------------------ ### Device Description and Intended Use UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports from a web-enabled computer, iPad or iPhone. UltraLing is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by qualified Physicians. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation. UltraLing conforms to the ACR/NEMA DICOM 3.0 standard for interoperability with other DICOM compliant systems. #### Indications for Use UltraLing is a software imagement system intended to receive, process, review, display, and archive medical images and data from imaging modalities (e.g. Ultrasound (US). and Magnetic Resonance (MR)). Images and data can be stored, communicated and displayed across computer systems and mobile devices. UltraLinq is a single system that can run on a web-enabled computer. iPad and iPhone and may be interfaced with other PACS systems. Diagnosis is not performed by the software but by qualified Physicians. Typical users of this system are trained and qualified professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. UltraLinq is used to: - share reports and studies with other UltraLinq users, - . review reports and studies, - download and save reports and studies, ● - send reports and studies to EMR and EHR systems, and ● - . route reports and studies to other UltraLing users. UltraLinq provides access to medical images on mobile devices for non-diagnostic viewing and referral purposes. The mobile device access functionality is used for patient management by the medical community in order to access and display patient data, medical reports, and medical images. Mobile devices are not intended to replace full diagnostic workstations and should be used only when there is no access to a workstation. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular {5}------------------------------------------------ function evaluation. This measurement, available on workstations only, can be used to assist the clinician in cardiac evaluation. This device is not to be used for mammography. ## Substantial Equivalence UltraLinq is substantially equivalent to predicate devices currently on the market. These devices are: - . ASTRA by Candelis, Inc - K111694 (primary predicate device) - LVivo EF Software Application by DiACardio, Ltd K130779 (secondary predicate ● device) UltraLinq has the same intended use and indications for use as the predicate devices. The table below provides a detailed comparison of UltraLinq to the predicate devices. ### Detailed Comparison of the Subject and Predicate Devices {6}------------------------------------------------ | Item | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison | |---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | UltraLinq UltraLinq is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation. Diagnosis is not performed by the software but by qualified Physicians. | ASTRA ASTRA is intended to be used by trained professionals, e.g. Physicians, radiologists, nurses, medical technicians, and assistants to receive, process, review, display, print and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians. | LVivo EF Software Application LVivo EF Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation. | Identical to the LVivo EF Software Application. Equivalent to ASTRA with the exception that UltraLinq does not print images. | | Indications for Use | UltraLinq is a software image management system intended to receive, process, review, display, and archive medical | ASTRA is software image management intended to receive, process, review, display, print and archive medical images and data | LVivo EF Software Application is intended for non-invasive processing of already acquired | Identical to LVivo EF Software Application Equivalent to ASTRA with the exception that | | | | | | | | images and data from | from imaging modalities | echocardiographic | UltraLinq does not print | | | imaging modalities (e.g. Ultrasound (US), and | (e.g. CR and DR). Images | images in order to | images and is not to be | | | Magnetic Resonance | and data can be stored, | detect, measure, and | used for mammography. | | | (MR)). Images and data | communicated, and | calculate the left | Also, equivalent to | | | can be stored, | displayed within the | ventricular wall for left | ASTRA, UltraLinq | | | communicated and | system or across | ventricular function | provides three different | | | displayed across computer | computer systems. | evaluation. This | interfaces and runs on | | | systems and mobile | ASTRA is comprised with | measurement can be | iPad and iPhone but | | | devices. UltraLinq is a | three configurations | used to assist the | instead of 3 different | | | single system that can run | depending upon the | clinician in a cardiac | configuration | | | on a web-enabled | requirements of the user | evaluation. | implementations as | | | computer, iPad and iPhone | and desired options: ASTRA PLUS, ASTRA | | provided by ASTRA, | | | and may be interfaced with | Lite, and ASTRA Mobile. | | UltraLinq is comprised of | | | other PACS systems. | ASTRA runs on a PC | | a single configuration. | | | Diagnosis is not performed | workstation, iPad, or | | | | | by the software but by | iPhone and may be | | | | | qualified Physicians. | interfaced with verified | | | | | Typical users of this system | and validated image | | | | | are trained and qualified | acquisition devices from | | | | | professionals, e.g. | Candelis or other PACS | | | | | physicians, radiologists, | systems. Diagnosis is not | | | | | nurses, medical | performed by the software | | | | | technicians, and assistants. | but by Radiologists, Clinicians or referring | | | | | UltraLinq is used to: | Physicians. Typical users | | | | | • share reports and studies with other UltraLinq users, | of this system are trained professionals, e.g. | | | | | • review reports and studies, | physicians, radiologists, nurses, medical | | | | | • download and save reports and studies, | technicians, and assistants. | | | | | • send reports and studies to EMR and EHR systems, and | ASTRA Plus is used to: share reports and studies | | | | | • route reports and studies | with other ASTRA peers, | | | | {7}------------------------------------------------ {8}------------------------------------------------ | to other UltraLinq users. UltraLinq provides access to medical images on mobile devices for non- diagnostic viewing and referral purposes. The mobile device access functionality is used for patient management by the medical community in order to access and display patient data, medical reports, and medical images. Mobile devices are not intended to replace full diagnostic workstations and should be used only when there is no access to a workstation. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstation only, can be used to assist the clinician in cardiac evaluation. This device is not to be used for mammography. | review reports and studies, download and save reports, send reports to local EMR, HER, RIS, HIS or PACS systems (HL7 send), route studies to PACS, Workstations, or other ASTRA peers. ASTRA Lite is used to: share reports and studies with ASTRA peers, review reports and studies, download and save reports, send reports to local EMR, HER, RIS, HIS or PACS system s (HL7 send). ASTRA Mobile is used to: share reports with other ASTRA peers, review reports, download and save reports, send reports to local EMR, HER, HIS or PACS systems (HL7 send). Only pre-processed DICOM for presentation images can be interpreted by primary image diagnosis in mammography. Lossy compressed Mammographic images | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| {9}------------------------------------------------ | | | and digitized film screen images may only be interpreted using and FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA. | | | |-------------------------------------------------------------------------------------------------------------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------------------------------------------------------------| | Internet Based Software | Yes | Yes | No | Equivalent to ASTRA | | Receive, store, retrieve, process, review, and/or display Medical Images | Yes | Yes | Yes | Equivalent to ASTRA and LVivo EF Software Application | | Receives DICOM images from Imaging modalities. | Yes | Yes | Yes | Equivalent to ASTRA and LVivo EF Software Application. | | Cloud-based computing and storage for transfer and sharing of studies, images and reports | Yes | Yes | No | Equivalent to ASTRA. | | Software operates on off-the-shelf hardware | Yes | Yes | Yes | Equivalent to ASTRA and LVivo EF Software Application | | Image storage and archive server | Yes | Yes | No | Equivalent to ASTRA | | Displays images on mobile devices | Yes | Yes | No | Equivalent to ASTRA | | Conforms to DICOM Standard | Yes | Yes | Yes | Equivalent to ASTRA and LVivo EF Software | | for interoperability with other DICOM compliant systems | | | | Application | | Routing of images | Yes | Yes…

UltraLinq

Device Facts

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

UltraLinq

Device Facts

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps