K Number

Device Name

Aid-U

Manufacturer

iAID

Date Cleared

2024-02-08

(246 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

Aid-U is a software solution intended to be used for storing, zoom-out, retrieving, transmitting, and processing medical images, or outputting them. Aid-U is intended for use as a web- based application and is networked with a PACS server. It enables the display, comparison of CT, MR, PT, US, XA, NM, DX, and SC from other DICOM compliant modalities. Typical users are radiologists, technologists, and clinicians.

Device Description

Aid-U is a medical image transmission device software, of SaaS type (Software as a Service, provided as a service, not as a software installation) or an On-Premise Software type web application (Companies install software in data centers managed by their own facilities) that allows patient medical image data generated by medical imaging devices to be transmitted, stored, managed, and retrieved using standard internet protocols (HTML5).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K143397, K171754

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard medical image management and viewing software with image processing capabilities, but there is no mention of AI, ML, deep learning, or any related terms or concepts in the provided text. The focus is on storage, retrieval, transmission, and display of images.

Therapeutic

No
The device is described as software for storing, retrieving, transmitting, and processing medical images, and its intended use is for display and comparison of images from various modalities. It does not exert any therapeutic effect on the patient.

Diagnostic

The device is described as a medical image transmission and management software. Its intended use is for storing, retrieving, transmitting, processing, and displaying medical images. It does not state that it analyzes images or patient data to provide diagnostic insights or findings.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Aid-U is a medical image transmission device software, of SaaS type... or an On-Premise Software type web application". It focuses on the software's function of transmitting, storing, managing, and retrieving medical image data. There is no mention of accompanying hardware components being part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Aid-U's function: Aid-U is described as a software solution for storing, retrieving, transmitting, processing, and displaying medical images. It works with images from various imaging modalities (CT, MR, etc.).
No mention of biological samples: The description of Aid-U's intended use and device description does not involve the analysis of any biological samples from the human body. Its function is solely related to the management and display of medical images.

Therefore, Aid-U falls under the category of medical image management and viewing software, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

LLZ

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MR, PT, US, XA, NM, DX, and SC from other DICOM compliant modalities.

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

radiologists, technologists, and clinicians.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were conducted for the device Aid-U during product development.
The risk analysis was completed, verification and validation tests were performed to support the claim of substantial equivalence, and the test results support that all software specifications meet the acceptance criteria. It complies with cybersecurity requirements by implementing processes to prevent unauthorized access, modification, misuse, or refusal to use information stored, accessed, or transmitted by medical devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K143397, K171754

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

iAID Jooyoung Park Quality Development Manager #1307 6, Wiryeseong-daero, Songpa-gu Seoul. 05544 Korea, South

February 8, 2024

Re: K231662 Trade/Device Name: Aid-U Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: January 10, 2024 Received: January 10, 2024

Dear Jooyoung 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Indications for Use

510(k) Number (if known) K231662

Device Name Aid-U

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

ü 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."

Image /page/3/Picture/0 description: The image shows the logo for iAID. The logo consists of a 3D cube-like shape on the left, with the letters 'iAID' to the right of the shape. The cube shape is made up of different shades of blue, while the 'i' is gray, the 'A' is blue with a yellow accent, and the 'ID' is gray.

K231662 510(k) Summary

1. Applicant / Submitter

Submitter:	iAID
	#1307 6, Wiryeseong-daero,
	Songpa-gu, Seoul, Republic of Korea [05544]
Contact person (application correspondent):
	- Name : Jooyoung Park
	- Title : Quality Manager
	- Phone number : +82-10-9033-4422
	- E-mail address : chacha4422@gmail.com
Date Prepared:	Feb 07, 2024

2. Proposed Device

Device	System, Image Processing, Radiological
Trade/Device Name	Aid-U
Regulation Number	21 CFR 892.2050
Device Classification Name	Medical Image Management and Processing System
Regulatory Class	Class II
Product Code	LLZ
Classification Panel	Radiology Devices

3. Device Description

4. Indication for use

Aid-U is a software solution intended to be used for storing, zoom-in, zoom-out, retrieving, transmitting, and processing medical images, or outputting them. Aid-U is intended for use as a web- based application and is networked with a PACS server. It enables the display, comparison of CT, MR, PT, US, XA, NM, DX, and SC from other DICOM compliant modalities. Typical

Image /page/4/Picture/0 description: The image shows the logo for iAid. The logo consists of a blue cube-like shape with the letters "AI" in white on the front. To the right of the cube is the text "iAid" in gray, with the "A" in "iAid" having a green and yellow accent.

users are radiologists, technologists, and clinicians.

5. Technology

Aid-U is a software system that enables health care professionals to access, manipulate in realtime, medical images using any web-browser without installing client software without restrictions of device/location. PACS application program is executed based on Wildfly application server, which is SubSYS-WILDFLY. Based on security communication, logging, DICOM tags stored in DB, and file storage information stored in SubSYS-LDAP, the initialization database SubSYS-POSTGRESOL is used to store, search, and search medical images and meta information. Storage, inquiry and search functions are provided only to authorized users in SubSYS-KEYCLOAK, and unauthorized access is blocked. In addition, it provides a web browser-based PACS/Web viewer UI that can store and search medical images and meta information by interacting with the PACS application program.

6. Predicate Device

Subject Device	Primary Predicate Device	Additional Predicate Device
Aid-U	Agfa HealthCare's
ICIS View
(K143397)	Novarad Corporation
NovaPACS
(K171754)
Functionality	Subject Device	Predicate Device	Predicate Device
		Agfa HealthCare's	Novarad Corporation
		ICIS View	NovaPACS
		(K143397)	(K171754)
Device Name	Aid-U	ICIS View	NovaPACS
Classification	Class II	Class II	Class II
Regulatory Number	21 CFR 892.2050	21 CFR 892.2050	21 CFR 892.2050
Product Code	LLZ	LLZ	LLZ
Modalities	CT, MR, PT, US, XA, NM, DX, SC	CR, DX, CT, MR, US,	CT, MR, US, CR/DX, NM, PT, and XA
Communication	Same as predicates	DICOM	DICOM
Indication for Use	Aid-U is a software solution intended to be used
for storing, zoom-in, zoom-out, retrieving,
transmitting, and processing medical images, or
outputting them. Aid-U is intended for use as a
web- based application and is networked with a
PACS server. It enables the display, comparison
of CT, MR, PT, US, XA, NM, DX, and SC from
other DICOM compliant modalities. Typical
users are radiologists, technologists, and
clinicians.	ICIS® View is a software application used
for reference viewing of medical images and
associated reports and, as such, fulfills a key
role in Agfa HealthCare's Imaging Clinical
Information System (ICIS). ICIS® View
enables healthcare professionals, including
(but not limited to) physicians, surgeons,
nurses, and administrators to receive and
view patient images and data from multiple
departments and organizations within one
multidisciplinary viewer. Users may access
the product directly via a web-browser,
select mobile devices, healthcare portal or
within the Electronic Medical Record
(EMR). ICIS® View allows users to perform
basic image manipulations and
measurements (for example window/level,
rotation, zoom, and markups). ICIS® View
can optionally be configured for Full Fidelity
mode, which is intended for diagnostic use,
review and analysis of CR, DX, CT, MR,	NovaPACS is intended for the viewing,
archiving, analysis, annotation, registration,
distribution, editing, fusion, and processing
of digital medical images and data acquired
from diagnostic imaging devices and all
DICOM devices, including mammography.
NovaPACS is intended for use by trained
healthcare professionals, including
radiologists, physicians, technologists,
clinicians, and nurses. NovaPACS allows the
end user to display, manipulate, archive, and
evaluate images.
Mobile devices are not intended to replace a
full workstation and should be used only
when there is no access to a workstation.
They are not to be used for mammography or
fMRI. Mobile devices are used for diagnosis
of medical images
from different modalities including CT, MR,
US, CR/DX, NM, PT, and XA. For a list of
compatible mobile platforms see NovaPACS

		US images and medical reports. ICIS® View
Full Fidelity is not intended to replace full
diagnostic workstations and should only be
used when there is no access to a
workstation. ICIS® View full fidelity is not
intended for the display of digital
mammography images for diagnosis.	Diagnostic Viewer User Manual. While
NovaPACS full workstation provides tools
to assist the healthcare professional
determine diagnostic viability, it is the user's
responsibility to ensure quality, display
contrast, ambient light conditions, and to
confirm image compression
ratios are consistent with the generally
accepted standards of the clinical
application.
NovaPACS is intended for providing
analysis and visualization of functional MRI
data of the human brain, presenting derived
properties and parameters in a clinically
useful context.
Window Level	Same as primary predicate	Yes	Yes
User Authentication	Same as primary predicate	Yes	Yes
Network Access	Web browser connects to
existing PACS	Web browser connects to
existing PACS	Workstation, and
NovaWeb Web Viewer.
Transfer/Storage/Display
of Medical Images	Same as primary predicate	Yes	Yes
Pan/Zoom	Same as primary predicate	Yes	Yes
Measurement	Same as primary predicate	Yes	Yes
Annotation	Same as primary predicate	Yes	Yes

7. Determination of Substantial Equivalence

Aid-U has the same intended use, principle of operation, and similar technological features to the predicate devices ICIS (K143397) and NovaPACS (K171754).

There might be slight differences in features and menu, but these differences between the predicate devices and the proposed device do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation and verification tests, we conclude that the proposed device is substantially equivalent to the predicate devices.

Image /page/5/Picture/0 description: The image shows the logo for iAID. The logo consists of a blue cube-like shape with the letters 'AI' on the left side. To the right of the cube is the text 'iAID' in gray and blue.

Comparison Table:

Image /page/6/Picture/0 description: The image shows the logo for iAID. The logo consists of the letters "Ai" in blue and the letters "AID" in gray. The "i" in "iAID" is lowercase, while the other letters are uppercase.

Image /page/7/Picture/0 description: The image shows the logo for iAID. The logo consists of a blue 3D cube with the letters "AI" on the left side of the image. To the right of the cube are the letters "iAID" in gray, with a small yellow accent on the "A". The logo is simple and modern, and the colors are eye-catching.

8. Summary of Non-Clinical Test

Non-clinical tests were conducted for the device Aid-U during product development.

. NEMA PS 3.1 - 3.15, 3.18 (2016). Digital Imaging and Communication in Medicine (DICOM)
. ISO/IEC 15444-1:2016 (JPEG 2000)
IEC 62304:2015, Medical devices software Software life-cycle processes .
. ISO 14971:2019 Medical devices - Application of risk management to medical devices
. IEC TR 80002-1:2009, Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
. AAMI TIR57:2016, Principles for medical device security-Risk management

The risk analysis was completed, verification and validation tests were performed to support the claim of substantial equivalence, and the test results support that all software specifications meet the acceptance criteria. It complies with cybersecurity requirements by implementing processes to prevent unauthorized access, modification, misuse, or refusal to use information stored, accessed, or transmitted by medical devices.

9. Safety and Effectiveness Information:

Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device. The results of the hazard analysis, combined with the appropriate preventive measures Taken, indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

10. Conclusion

The new device Aid-U and predicate device are substantially equivalent in the areas of technical characteristics, general functions, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is as safe and effective as the predicate devices currently on the market.