Healium Intelliscan LX192LC
Device Facts
| Record ID | K261132 |
|---|---|
| Device Name | Healium Intelliscan LX192LC |
| Applicant | Healium Intelliscan Corporation |
| Product Code | IYN · Radiology |
| Decision Date | May 5, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Healium Intelliscan LX192LC is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD).Specific clinical applications and exam types including: Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,Nerve The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.
Device Story
Portable, handheld ultrasound system; acquires/displays real-time ultrasound data; consists of wireless dual-headed transducer (linear/convex) and mobile application. Transducer uses Wi-Fi to communicate with COTS tablet/smartphone; system includes multichannel beamformer, prescan converter, and battery. Operated by qualified physicians/healthcare professionals in clinical environments. User interacts via icon touch-based interface on mobile device to view images; supports B, M, PWD, Color Doppler, Power Doppler, and combined modes. Output facilitates diagnostic evaluation and fluid flow analysis; aids clinical decision-making through real-time visualization of internal structures.
Clinical Evidence
Bench testing only. Device complies with recognized standards for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366-1), home healthcare environment (IEC 60601-1-11), ultrasonic diagnostic equipment (IEC 60601-2-37), battery safety (IEC 62133-2), software lifecycle (IEC 62304), biocompatibility (ISO 10993-1, -5, -10, -23), and risk management (ISO 14971).
Technological Characteristics
Handheld ultrasound system; dual-headed transducer (linear/convex); Wi-Fi connectivity to COTS mobile devices. Features multichannel beamformer, prescan converter, and rechargeable lithium battery. Software-controlled; supports B, M, PWD, Color Doppler, and Power Doppler modes. Complies with IEC 60601-1, 60601-1-2, 60601-2-37, 62304, and ISO 10993 standards.
Indications for Use
Indicated for qualified physicians and healthcare professionals to conduct ultrasound scans and fluid flow analysis for fetal, abdominal, pediatric, small organ, neonatal cephalic, trans-rectal, trans-vaginal, urological, musculoskeletal, OB/Gyn, cardiac, peripheral vessel, carotid, pulmonary, and nerve applications. Not for use in emergency medical services, ambulances, or aircraft.
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
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
May 5, 2026
Healium Intelliscan Corporation
% George Hattub
Senior Medical Device Regulatory Affairs Specialist
Medicsense USA, LLC
291 Hillside Ave.
Somerset, Massachusetts 02726
Re: K261132
Trade/Device Name: Healium Intelliscan LX192LC
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: April 6, 2026
Received: April 6, 2026
Dear George Hattub:
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
{1}
K261132 - George Hattub
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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 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 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-
{2}
K261132 - George Hattub
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
{3}
| 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. | K261132 | ? |
| Please provide the device trade name(s). | | ? |
| Healium Intelliscan LX192LC | | |
| Please provide your Indications for Use below. | | ? |
| The Healium Intelliscan LX192LC is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD).Specific clinical applications and exam types including: Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,Nerve The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft. | | |
| 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) | ? |
{4}
HEALIUM Intelliscan
510(k) Summary K261132
(21 CFR 807.92)
1. Submitter Information
Healium Intelliscan Corporation
26 Broadway
Suite 934-G68
New York, NY 10004
United States
Contact Person:
George Hattub, Senior Regulatory Affairs Medical Device Specialist
Email: ghattub@medicsenseusa.com
2. Submission Information
Submission Type: Special 510(k) Premarket Notification
Device Name: Healium Intelliscan LX192LC
Common Name: Diagnostic Ultrasound System and Accessories
Regulation Numbers: 21 CFR 892.1550, 892.1560, 892.1570
Product Codes: IYN, IYO, ITX
Device Class: II
Review Panel: Radiology
3. Predicate Device
Predicate Device: K243226
4. Device Description
Portable ultrasound imaging system with dual-headed transducer (linear and convex), mobile application, Wi-Fi connectivity, and Doppler imaging modes.
The Ultrasound Imaging System is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data.
{5}
The imaging system software runs as an app on a mobile device.
The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
The imaging system consists of a wireless transducer employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi.
This allows the user to export ultrasound images and display them across a range portable personal device. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
# 5. Intended Use / Indications for Use
The Healium Intelliscan LX192LC is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode $(\mathrm{B} + \mathrm{M}, \mathrm{B} + \mathrm{CD}, \mathrm{B} + \mathrm{PWD})$ . Specific clinical applications and exam types including:
Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Trans-rectal, Trans-vaginal, Urology, Musculoskeletal (conventional), Musculoskeletal (superficial), OB/Gyn, Cardiac (adult), Cardiac (pediatric), Peripheral vessel, Other (Carotid), Pulmonary, Nerve
The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.
# 6. Technological Characteristics
Identical to predicate in design, materials, energy source, software, and performance.
{6}
# 7. Substantial Equivalence
Differences limited to manufacturer name change and removal of ophthalmic indications. No impact on safety or effectiveness.
Substantial Equivalence Comparison Table
| Feature | Subject Device (Healium Intelliscan LX192LC) | Predicate Device (K243226) | Comparison/Conclusion |
| --- | --- | --- | --- |
| Indications for Use | Same as predicate except removal of ophthalmic applications | Includes ophthalmic and all other indications | Narrowing of indications; does not change intended use |
| Intended Use | Diagnostic ultrasound imaging and fluid flow analysis | Same | Identical |
| Design | Handheld ultrasound system with dual-headed probe and mobile platform | Same | Identical |
| Materials | No change | Same | Identical |
| Principle of Operation | Ultrasonic transmission/reception and beamforming | Same | Identical |
| Energy Source | Rechargeable battery | Same | Identical |
| Software | No change | Same | Identical |
| Performance | Same imaging modes and specifications | Same | Identical |
| Manufacturing | Manufactured by Leltek Inc. (contract manufacturer) | Manufactured by Leltek Inc. | No change in manufacturing |
{7}
# 8. Performance Data
The Ultrasound Imaging System has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards:
| Date of Entry | Recognition Number | Standard Developing Organization | Standard Designation Number/Date | Title of Standard |
| --- | --- | --- | --- | --- |
| 05/30/2022 | 19-46 | ANSI AAMI | ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [including Amendment 2 (2021)] |
| 12/21/2020 | 19-36 | ANSI AAMI IEC | 60601-1-2:2014 [including AMD 1:2021] | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [including Amendment 1 (2021)] |
| 12/21/2020 | 5-132 | IEC | 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 12/21/2020 | 19-38 | IEC | 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 06/27/2016 | 12-293 | IEC | 60601-2-37 Edition 2.1 2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 12/23/2019 | 19-33 | IEC | 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems |
| 01/14/2019 | 13-79 | ANSI AAMI IEC | 62304:2006/A1:2016 | Medical device software - Software life cycle processes [including Amendment 1 (2016)] |
| 07/06/2020 | 5-129 | ANSI AAMI IEC | 62366-1:2015+AMD1:2020 (Consolidated Text) | Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1 |
| 01/14/2019 | 2-258 | ISO | 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| 12/23/2016 | 2-245 | ISO | 10993-5 Third edition 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| 12/19/2022 | 2-296 | ISO | 10993-10 Fourth edition 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
| 06/07/2021 | 2-291 | ISO | 10993-23 First edition 2021-01 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| 12/20/2021 | 5-134 | ISO | 15223-1 Fourth edition 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements |
| 12/23/2019 | 5-125 | ISO | 14971 Third Edition 2019-12 | Medical devices - Application of risk management to medical devices |
# 9. Safety and Effectiveness
No new risks introduced. Removal of ophthalmic indication reduces risk.
# 10. Manufacturing
Manufactured by Leltek Inc. as contract manufacturer. Healium assumes legal manufacturer responsibility.
# 11. Conclusion
Device is substantially equivalent to predicate and remains safe and effective.
