ES-Series

K260748 · E-Scopics · IYN · Jun 9, 2026 · Radiology

Device Facts

• Record ID: K260748
• Device Name: ES-Series
• Applicant: E-Scopics
• Product Code: IYN · Radiology
• Decision Date: Jun 9, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K260748 · Jun 9, 2026	ES-Series	E-Scopics	Pooled clinical investigation cohort data (retrospective)	Retrospective analysis of 95 patients comparing the device's HDFF index against MRI-PDFF reference standard to validate diagnostic performance for liver steatosis.	Retrospective analysis; Liver steatosis; MRI-PDFF; Diagnostic validation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective analysis of pooled cohort data; Retrospective analysis	95 independent patients with liver disease; Sample Size: 95	MRI-PDFF reference scan	Correlation with MRI-PDFF, AUROC for detection of liver steatosis (≥5% MRI-PDFF), Bland-Altman agreement

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Hepatoscope ultrasound-derived fat fraction index (HDFF)	Supervised quantitative ultrasound parameter combination	Correlation ≥ 0.85; AUROC ≥ 0.92; Mean Bias ± 8.5%	Correlation 0.93; AUROC 0.93; Mean Bias +0.04%	—	—	Retrospective analysis of 95 independent patients from three clinical investigations in France and the United States.	—

Indications for Use

The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide: - Linear distance measurements of anatomical structures, - Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, - Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies - Measurement of brightness ratio between structures and in particular between the liver and the kidney, - Estimates of speed of sound in the liver, - Estimates of an ultrasound-derived fat fraction index. The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease. The Hepatoscope ultrasound-derived fat fraction index (HDFF) may be used as an aid to the clinical management of adult patients with liver steatosis.

Device Story

Ultraportable ultrasound imaging system; consists of external transabdominal probe with mechanical vibrator for shear wave generation; connects via USB-C to consumer off-the-shelf host running Hepatoscope App. System acquires raw ultrasound data; processes signals for B-mode imaging, elastography, attenuation, backscattering, speed of sound, and fat fraction (HDFF). Operated by trained healthcare professionals in clinical environments. Output displayed on host monitor for linear measurements, stiffness estimation, and diagnostic aid in liver disease/steatosis management. Benefits include non-invasive quantitative assessment of liver/spleen tissue properties.

Clinical Evidence

Retrospective analysis of 95 patients (mean age 58.7, 67% BMI >30 kg/m²) compared HDFF against MRI-PDFF reference standard. Results: correlation 0.93 (95% CI: 0.89-0.95); AUROC 0.93 (95% CI: 0.87-0.97) for steatosis detection (≥5% MRI-PDFF); Bland-Altman mean bias +0.04% (LoA [-7.3%, +7.4%]). Bench testing on phantoms confirmed accuracy of signal processing for spleen stiffness and HDFF.

Technological Characteristics

Ultraportable ultrasound system; transabdominal probe with mechanical vibrator; USB-C connectivity to host. Modalities: B-mode, 2D-Transient Elastography, shear wave speed, attenuation, backscattering, speed of sound. Software-based processing on host. Electrical safety per IEC 60601-2-37.

Indications for Use

Indicated for abdominal imaging and liver/spleen physical property measurements in adult and pediatric patients. HDFF index indicated for adult patients with liver steatosis.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Hepatoscope (K232336)
• ACUSON S3000, S2000 Diagnostic Ultrasound System (K183575)
• FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini +, 230, and 630) (K223902)

Reference Devices

• ACUSON S3000, S2000 Diagnostic Ultrasound System (K183575)

Submission Summary (Full Text)

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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION

E-Scopics
Aurelie Gruener
QARA Director
235 Rue Léon Foucault
Aix-En-Provence, 13290
France

June 9, 2026

Re: K260748

Trade/Device Name: ES-Series

Regulation Number: 21 CFR 892.1550

Regulation Name: Ultrasonic Pulsed Doppler Imaging System

Regulatory Class: Class II

Product Code: IYN, IYO, ITX

Dated: May 7, 2026

Received: May 7, 2026

Dear Aurelie Gruener:

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.

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

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K260748 - Aurelie Gruener

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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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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K260748 - Aurelie Gruener

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Michael D. O'hara -

S

Date: 2026.06.09 08:41:34 -04'00'

For

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

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# Indications for Use

| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260748 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| ES-Series | | |
| Please provide your Indications for Use below. | | ? |
| The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide: - Linear distance measurements of anatomical structures, - Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, - Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies - Measurement of brightness ratio between structures and in particular between the liver and the kidney, - Estimates of speed of sound in the liver, - Estimates of an ultrasound-derived fat fraction index. The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease. The Hepatoscope ultrasound-derived fat fraction index (HDFF) may be used as an aid to the clinical management of adult patients with liver steatosis. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |

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510(k) #: K260748

510(k) Summary

Prepared on: 2026-06-04

# Contact Details

21 CFR 807.92(a)(1)

| Applicant Name | E-Scopics |
| --- | --- |
| Applicant Address | 235 Rue Léon Foucault Aix-en-Provence 13290 France |
| Applicant Contact Telephone | 0033664366992 |
| Applicant Contact | Mrs. AURELIE GRUENER |
| Applicant Contact Email | [e-mail] |

# Device Name

21 CFR 807.92(a)(2)

| Device Trade Name | ES-Series |
| --- | --- |
| Common Name | Ultrasonic pulsed doppler imaging system |
| Classification Name | System, Imaging, Pulsed Doppler, Ultrasonic |
| Regulation Number | 892.1550 |
| Product Code(s) | IYN, IYO, ITX |

# Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K232336 | Proprietary name: Hepatoscope; filed under ES Series V2 in K232336 | IYN |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound System | IYN |
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini +, 230, and 630) | IYO |

# Device Description Summary

21 CFR 807.92(a)(4)

ES Series is an ultraportable ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging and quantitative imaging studies. ES Series consists of a Software App (running on a consumer off-the-shelf Selected Host) and an accessory probe. The system produces images and quantifications, which are displayed on the monitor of the Selected Host. ES Series is operated from the Selected Host and allows the user to perform measurements, to capture images, and to generate printable reports.

The product is an ultraportable software-based ultrasound imaging device that is composed of an external transabdominal ultrasound probe equipped with a mechanical vibrator to produce shear waves in tissue, and connected to an off-the-shelf software host via a standard USB-C cable. The system software is operated by the host and is responsible for controlling the probe, for processing ultrasound data, and for exam management. Operating functionalities performed by the digital probe are limited to the transmission, the reception and the digitization of ultrasound signals, before transferring them to the processing host via the USB-C cable. This processing host runs the Hepatoscope App, which ensures the following functions:

- Control of the ultrasound transmit/receive sequences by the probe;
- Processing of the raw ultrasound data that are received from the probe;
- Display of the reconstructed imaging information (images, quantitative parameters...)

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This ultrasound imaging device allows the operator to acquire information coming from quantitative imaging modalities such as elastography, ultrasound attenuation, speed of sound and Hepatoscope ultrasound-derived fat fraction index (HDFF). This can be done with real-time 2D imaging guidance.

## Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment.

The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide:

- Linear distance measurements of anatomical structures,
- Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen,
- Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies
- Measurement of brightness ratio between structures and in particular between the liver and the kidney,
- Estimates of speed of sound in the liver,
- Estimates of an ultrasound-derived fat fraction index.

The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease. The Hepatoscope ultrasound-derived fat fraction index (HDFF) may be used as an aid to the clinical management of adult patients with liver steatosis.

## Indications for Use Comparison

21 CFR 807.92(a)(5)

The subject device maintains the same Intended Use as the predicate/reference devices, which is to provide general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters in internal structures of the body.

The addition of the Hepatoscope ultrasound-derived fat fraction index (HDFF) constitutes a change in the Indications for Use by providing an estimate of fat fraction derived from quantitative ultrasound parameters already analyzed by the predicate.

All improvements, additional features and labeling update of ES Series have gone through safety and performance testing, and do not raise any issue related to the intended use of the device.

Safety and effectiveness of the device is not affected as compared to the predicate/reference devices.

## Technological Comparison

21 CFR 807.92(a)(6)

ES Series has the same technological characteristics as the predicate/reference devices: same operating modalities, principles, features (B-mode, 2D-Transient Elastography, Shear Wave Speed estimation, attenuation coefficient, backscattering coefficient, and Speed of Sound), and associated combinations of modes.

For the introduction of the Hepatoscope ultrasound-derived fat fraction index (HDFF), the Ultrasonically Derived Fat Fraction (UDFF), from Siemens ACUSON S3000, S2000 Diagnostic Ultrasound System (K183575), was used as the reference device for this output measure. Both techniques use same supervised approach. The same as UDFF, the Hepatoscope ultrasound-derived fat fraction index (HDFF) combines parameters from quantitative ultrasound.

Safety and effectiveness of the device is not affected as compared to the reference device.

## Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

A series of non-clinical tests were performed to ensure that improvement of technological characteristics of ES Series do not affect the safety or effectiveness of the device. The following performance data were collected and analyzed:

- Electrical safety testing were conducted on the ES Series device. The device complies with the IEC 60601-2-37.
- Bench testing were conducted on calibrated phantoms to demonstrate the accuracy of the signal processing and ultrasound sequence refinements for spleen stiffness and Hepatoscope-derived fat fraction index (HDFF) estimation.
- Software Verification and Validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." The software for this device was considered as Basic Documentation Level.

The Hepatoscope-derived fat fraction index (HDFF) algorithm was validated through a retrospective analysis using pooled cohort data from three clinical investigations conducted in France and the United States. The analysis evaluated 95 independent patients who underwent both an ES Series ultrasound exam and an MRI-PDFF reference scan. Demographic distribution of the patients is summarized below:

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- Number of Patients: 95

- Sex (F, %): 49/95 (52%)

- Age (years):

- Mean ± SD: 58.7 ± 9.7

- Range: 27-78

- BMI, (kg/m²):

- Mean ± SD: 32.3 ± 5.5

- Range: 18.4-49.4

- BMI>30kg/m² n, (%): 64 (67%)

- MRI-PDFF (%):

- Mean ± SD: 13.3 ± 9.9

- Range: 0-44

The performance testing acceptance criteria were based on K183575 UDFF testing and results. The primary endpoints were successfully met, with HDFF demonstrating a correlation of 0.93 (95% CI: 0.89 to 0.95) against the MRI-PDFF reference standard, exceeding the acceptance criterion of ≥0.85. Additionally, it reached an AUROC of 0.93 (95% CI: 0.87 to 0.97) for the detection of liver steatosis (≥5% MRI-PDFF) against an acceptance criterion of ≥0.92. HDFF agreement against MRI-PDFF was confirmed via Bland-Altman analysis, which revealed a negligible Mean Bias of +0.04% and 95% Limits of Agreement of [-7.3%, +7.4%] (against an acceptance criterion of ±8.5%). No adverse events or complications associated with the device were reported during the investigations considered in this cohort.

# Conclusion:

ES Series demonstrated to be substantially equivalent to its Predicate Device and Reference Devices as they have the same intended use, and the technological differences do not raise issues of safety and effectiveness.

This has been demonstrated via clinical and non clinical data.