HESTIA is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. HESTIA is intended to be used in the same clinical applications as traditional film/screen systems.

Device Description

HESTIA is a Full-Field Digital Mammography (FFDM) System for screening, diagnostic on standing or seated patients. The system consists of a control unit with x-ray generator, a compression device(C-arm) with tube housing assembly, and X-ray tube stand, including detector and a console with an operation panel. The HESTIA comes with a variety of compression plates for diagnostic adjunct procedures.

The system is mainly used in internal medicine, examination centers, obstetrics and gynecology, women's medicine, breast surgery, and imaging. Mammography X-rays are used to obtain diagnostic images of the breast's internal structure to diagnose changes more accurately in breast tissue or potential signs of breast cancer, such as micro-calcification or tumors.

HESTIA has three output control mode, Manual mode, Semi-auto mode, and Auto mode.

It is customized and dedicated acquisition workstation and can PACS accessibility with full DICOM capability.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the HESTIA Mammography System DOES NOT CONTAIN the detailed information typically found in a study proving a device meets acceptance criteria, particularly for AI/CAD devices. The HESTIA device is a Full-Field Digital Mammography (FFDM) System, a hardware device for generating mammographic images, not an AI/CAD software for interpreting them.

The summary specifically states:

"A clinical image evaluation... was conducted with the HESTIA and determined that the images, reviewed by MQSA qualified expert radiologists, were of sufficiently acceptable quality for mammographic usage and that the images are substantially equivalent to those from predicate device."

This indicates a human-in-the-loop comparison of image quality (visual assessment by radiologists for diagnostic suitability) rather than an AI/CAD performance study with metrics like sensitivity, specificity, or AUC, which are common for AI algorithms. The "clinical image evaluation" mentioned is likely focused on demonstrating that the images produced by the HESTIA system are diagnostically acceptable and equivalent to those from the predicate device, not on assessing the performance of an AI against a ground truth established by experts.

Therefore, many of the requested items related to AI/CAD study design (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not provided in this document as it describes a hardware imaging system, not an AI interpretation software.

However, based on the information provided, here's what can be extracted and inferred, addressing as many points as possible:

Acceptance Criteria and Study for HESTIA Mammography System

As the HESTIA is a hardware Full-Field Digital Mammography (FFDM) system, not an AI/CAD software, the acceptance criteria and study design are primarily focused on demonstrating the system's ability to produce diagnostically acceptable images and its substantial equivalence to a predicate device in terms of image quality and safety. There is no indication of an AI component or AI performance metrics in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a FFDM system like HESTIA are typically related to image quality metrics, safety standards, and functional equivalence to predicate devices. The document summarizes compliance with these, rather than providing a quantitative table of specific acceptance thresholds and measured values for image interpretation performance (which would be relevant for AI).

Acceptance Criteria Category	Description/Reported Performance
Non-Clinical Testing	- Safety & Effectiveness: Demonstrated through compliance with internal requirements and international standards.- Electromagnetic Compatibility (EMC): Compliant with IEC 60601-1-2.- Radiation Protection: Compliant with IEC 60601-1-3.- Usability: Compliant with IEC 60601-1-6.- Mammographic X-ray Equipment Specifics: Compliant with IEC 60601-2-45.- Biocompatibility: Compliant with ISO 10993-1, -5, -10.- Software Life Cycle: Compliant with IEC 62304.- Risk Management: Compliant with ISO 14971.- Physical Laboratory Testing (Image Quality): Met all requirements for: Sensitometric response, Spatial resolution, Noise analysis, Signal-to-Noise Ratio Transfer-DQE, Dynamic range, Repeated exposures Test (Lag Effect), AEC Performance (CNR and SRN), Phantom tests (ACR Map, CDMAM), Patient radiation dose (Mean Glandular Dose). All tests demonstrated substantial equivalence to the predicate device.
Clinical Image Evaluation	- Images reviewed by MQSA qualified expert radiologists were determined to be of "sufficiently acceptable quality for mammographic usage."- Images were found to be "substantially equivalent to those from predicate device."
Intended Use	- "Generating mammographic images that can be used for screening and diagnosis of breast cancer."- "Intended to be used in the same clinical applications as traditional film/screen systems." (Met, as indications for use are identical to the predicate device).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" sample size in terms of patient cases for clinical evaluation, nor does it detail data provenance (country of origin, retrospective/prospective). The "clinical image evaluation" often involves a small number of images for visual quality assessment rather than a large clinical trial with diverse patient populations for diagnostic accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not explicitly stated. The statement refers to "MQSA qualified expert radiologists."
Qualifications: "MQSA qualified expert radiologists." (MQSA stands for Mammography Quality Standards Act, which sets federal standards for mammography facilities and personnel in the U.S. This implies they are board-certified and meet specific continuing education and interpretation requirements for mammography.)

4. Adjudication Method for the Test Set

Not specified, as this was an image quality assessment by radiologists rather than a diagnostic performance study requiring ground truth establishment through adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No information regarding an MRMC comparative effectiveness study for human readers with vs. without AI assistance. This type of study is relevant for AI/CAD devices, which is not what HESTIA is. The clinical evaluation focuses on the image quality produced by the HESTIA system being comparable to the predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.

Not applicable. HESTIA is a hardware imaging system, not a standalone AI algorithm.

7. The Type of Ground Truth Used

For the clinical image evaluation, the "ground truth" was based on the consensus/judgment of MQSA qualified expert radiologists regarding the diagnostic acceptability and equivalence of the image quality produced by the HESTIA system compared to the predicate device. This is distinct from establishing a clinical ground truth (e.g., biopsy-proven cancer) for an AI's diagnostic performance.

8. The Sample Size for the Training Set

Not applicable. HESTIA is a hardware device; thus, there is no mention of a training set as would be required for an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a hardware device.

Summary

FDA 510(k) Clearance Letter - HESTIA Mammography System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 17, 2025

GENORAY Co., Ltd.
Jiyeon Choi
Manager
60, Dunchon-daero 541beon-gil
Jungwon-gu
Seongnam-si, Gyeonggi-do 13212
Korea, South

Re: K243420
Trade/Device Name: HESTIA
Regulation Number: 21 CFR 892.1715
Regulation Name: Full-field digital mammography system
Regulatory Class: Class II
Product Code: MUE
Dated: June 10, 2025
Received: June 10, 2025

Dear Jiyeon Choi:

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.

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K243420 - Jiyeon Choi
Page 2

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 (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-reporting-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 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K243420 - Jiyeon Choi
Page 3

assistance/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,

YANNA S. KANG -S

Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K243420

Device Name: HESTIA

Indications for Use (Describe):
HESTIA is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. HESTIA is intended to be used in the same clinical applications as traditional film/screen systems.

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:

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Page 5

510(k) Summary

510(k)#: K243420
Prepared on: 2025-07-17

Contact Details

21 CFR 807.92(a)(1)

Field	Information
Applicant Name	GENORAY Co., Ltd.
Applicant Address	60, Dunchon-daero 541beon-gil Jungwon-gu Seongnam Gyoenggido 13212 Korea, South
Applicant Contact Telephone	+82315178570
Applicant Contact	Ms. INYOUNG KIM
Applicant Contact Email	iykim@genoray.com

Device Name

21 CFR 807.92(a)(2)

Field	Information
Device Trade Name	HESTIA
Common Name	Full-field digital mammography system
Classification Name	Full Field Digital, System, X-Ray, Mammographic
Regulation Number	892.1715
Product Code(s)	MUE

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K212873	Aspire Cristalle	MUE

Device Description Summary

21 CFR 807.92(a)(4)

HESTIA has three output control mode, Manual mode, Semi-auto mode, and Auto mode.

It is customized and dedicated acquisition workstation and can PACS accessibility with full DICOM capability.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use for HESTIA are the same as for the predicate device.

Page 6

Technological Comparison

21 CFR 807.92(a)(6)

HESTIA has identical indications for use and technical characteristic as its predicate device.

The characteristics of HESTIA is identical to those of the predicate device regarding indication for use, patient population, exposure mode, x-ray focal spot size, target material, target angle, kV range, Type of geometry, Software Controlled functions(AEC Calculation, DICOM)

The criteria below are similar or different. but, There is no significant difference between the HESTIA and the predicate device that would adversely affect the use of the product.

Breast Compression system
Added filter is similar to that of predicate device, but provides more option than predicate device. Inherent filtration is similar to that of predicate device, but has a lower than predicate device.
Nominal maximum output power, mAs range, SID, Source to breast support distance are similar to that of predicate device, these values are higher than predicate device at a value of similar level.
Sensor material of the detector is different for the predicate device and subject device, but the active area and active array are similar.
Operating system is similar to that of predicate device.

Even though the predicate device and the subject device differ, the differences are not critical in terms of the diagnostic purposes because the clinical image evaluation demonstrate that the subject devices are substantially equivalent to the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

[Summary of Non-Clinical data]
To demonstrate the safety and effectiveness of HESTIA and to show substantial equivalence to the predicate device, HESTIA completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The HESTIA passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

HESTIA has been tested by 3rd party Nationally Recognized Testing Laboratories to be in compliance with the following International Standards:

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-3 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC 60601-2-45 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
IEC 62304 Medical device software - Software life cycle processes
ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.

And Physical laboratory testing in accordance with the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System issued on April 4, 2012 (Section 9 Clinical Image Evaluation) was conducted with the HESTIA. For all tests, the proposed device demonstrated substantial equivalence to the predicate device.

Summary of physically laboratory testing results:

Sensitometric response
Spatial resolution
Noise analysis
Signal-to-Noise Ratio Transfer-DQE
Dynamic range
Repeated exposures Test (Lag Effect)
AEC Performance (CNR and SRN)
Phantom test - ACR Map
Phantom test - CDMAM

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Patient radiation dose - Mean Glandular Dose

[Summary of Clinical data]
A clinical image evaluation in accordance with the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System issued on April 4, 2012 (Section 9 Clinical Image Evaluation) was conducted with the HESTIA and determined that the images, reviewed by MQSA qualified expert radiologists, were of sufficiently acceptable quality for mammographic usage and that the images are substantially equivalent to those from predicate device.

[Conclusion]
HESTIA has the same intended use as the predicate device. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, HESTIA has been determined to be substantially equivalent to predicate device.

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.