HS40 Diagnostic Ultrasound System

• K Number: K191055
• Device Name: HS40 Diagnostic Ultrasound System
• Manufacturer: Samsung Medison Co., Ltd.
• Date Cleared: 2019-06-12 ( 54 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The HS40 ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Device Description

The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS40 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Predicate Devices

K180409, K181336, K133505, K182894

Reference Devices

K180409, K181336, K133505, K182894

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging modes and analysis packages.

Therapeutic

No
The device is described as an "ultrasound diagnostic system" whose function is to "acquire ultrasound data and to display the data" and "offers analysis packages that provide information that is used to make a diagnosis". It is not intended for treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is an "ultrasound diagnostic system." The "Device Description" also refers to it as a "diagnostic ultrasound system" and mentions that it provides "analysis packages that provide information that is used to make a diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducers, processing unit, display, etc.) in addition to software. The performance studies also mention evaluations of acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, all of which relate to hardware aspects of the device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use/Indications for Use: The primary purpose is to obtain ultrasound images and analyze body fluids. While it mentions analyzing body fluids, the context is within the scope of diagnostic imaging for various anatomical sites. It does not describe testing samples in vitro (outside the body) to diagnose conditions.
• Device Description: The description focuses on the ultrasound imaging capabilities and analysis packages for anatomical structures. It does not mention any components or processes related to analyzing biological samples in vitro.
• Lack of IVD-specific information: The document does not contain any information typically associated with IVD devices, such as:
  • Specific analytes being measured.
  • Reagents or test kits used.
  • Sample types (blood, urine, etc.) being analyzed in vitro.
  • Performance metrics relevant to IVD testing (sensitivity, specificity, etc. in the context of a specific test).

The analysis of body fluids mentioned in the intended use is likely related to the interpretation of ultrasound images of fluid collections within the body, rather than performing laboratory-style testing on extracted samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HS40 ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Product codes

IYN, IYO, ITX

Device Description

The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS40 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Indicated Patient Age Range

Adult, Pediatric, Neonatal (implied by "Neonatal Cephalic" and "penis in adult, pediatric and neonatal patients")

Intended User / Care Setting

Competent health care professionals. (Care setting not specified but implied to be clinical/medical)

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)

The device has been evaluated for acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable FDA guidance and medical device safety standards. The HS40 and its applications comply with the following FDA-recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO10993-1, ISO14971, NEMA UD 2-2004, NEMA UD 3-2004.
The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s)

K180409, K181336, K133505, K182894

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Samsung Medison Co., Ltd. % Scully Kim Regulatory Affairs Specialist 3366. Hanseo-ro. Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA

June 12, 2019

Re: K191055

Trade/Device Name: HS40 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 17, 2019 Received: April 19, 2019

Dear Scully Kim:

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. 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 located 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.

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

1

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

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number K191055

Device Name HS40 Diagnostic Ultrasound System

Indications for Use (Describe)

The HS40 ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

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

X 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."

3

510(k) Premarket Notification - Traditional

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: K191055 Device Name: HS40 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 7, 9, 11, 12
	Neonatal Cephalic	P	P	P		P	Note 1	Note 8, 9, 11
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 7, 8, 9, 11, 12
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 7, 9, 11
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note 1	Note 2, 7, 9, 12
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7, 14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7, 14
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

4

510(k) Premarket Notification - Traditional

Image /page/4/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The wordmark is set against a blue, oval-shaped background, which is tilted slightly.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA3-16AD for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 7, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 2, 7, 9, 11
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 7, 9, 11, 12
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 7, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409 ; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+TD, B+DPD)

• Note 2: Includes imaging for guidance of biopsy
• Note 3: Includes infertility monitoring of follicle development
• Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel
• Note 7: Tissue Harmonic Imaging (THI)
• Note 8: 3D imaging
• Note 9: MultiVision (Spatial Compound Imaging)
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: Tissue Doppler Imaging (TDI)

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

5

510(k) Premarket Notification - Traditional

Image /page/5/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-8AD for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Note 2, 7, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 7, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 2, 7, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 7, 9, 11
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 7, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

6

510(k) Premarket Notification - Traditional

Image /page/6/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is set against a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CF4-9 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

7

510(k) Premarket Notification - Traditional

Image /page/7/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PN2-4 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note 1	Note 7
	Trans-rectal (See Note 13)
	Trans-vaginal (See Note 13)
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P		P	Note 1	Note 4, 7, 14
Cardiac	Cardiac Pediatric	P	P	P		P	Note 1	Note 4, 7, 14
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

• Note 2: Includes imaging for guidance of biopsy
  Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: Tissue Doppler Imaging (TDI)

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

8

510(k) Premarket Notification - Traditional

Image /page/8/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside of a blue, oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EVN4-9 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 9
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 7, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 9, 12
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)	P	P	P		P	Note 1	Note 2, 7, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+TD, B+DPD)

• Note 2: Includes imaging for guidance of biopsy
• Note 3: Includes infertility monitoring of follicle development
• Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel
• Note 7: Tissue Harmonic Imaging (THI)
• Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Image /page/8/Figure/24 description: The image contains text that indicates concurrence of the Center for Devices and Radiological Health (CDRH). It also mentions "Prescription Use" and references "Per 21 CFR 801.109". The text is centered and presented in a straightforward manner.

9

510(k) Premarket Notification - Traditional

Image /page/9/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is bold and sans-serif, and the letters are evenly spaced. The blue oval is slightly tilted, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: VN4-8 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by K180409; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging
  Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

10

510(k) Premarket Notification - Traditional

Image /page/10/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is set against a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: V5-9 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

11

510(k) Premarket Notification - Traditional

Image /page/11/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is set against a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: DP2B for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 12)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

12

510(k) Premarket Notification - Traditional

Image /page/12/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The logo is tilted slightly upwards.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-8 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

13

510(k) Premarket Notification - Traditional

Image /page/13/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The logo is tilted slightly upwards.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-5 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

14

510(k) Premarket Notification - Traditional

Image /page/14/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The logo is tilted slightly upwards.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-6BM for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by 180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

• Note 3: Includes infertility monitoring of follicle development
• Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel
• Note 7: Tissue Harmonic Imaging (THI)
• Note 8: 3D imaging
• Note 9: MultiVision (Spatial Compound Imaging)
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaqinq
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate Note 14: Tissue Doppler Imaging (TDI)

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

15

510(k) Premarket Notification - Traditional

Image /page/15/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is set against a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LN5-12 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 2, 5, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

16

510(k) Premarket Notification - Traditional

Image /page/16/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is set against a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L5-12/50 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 2, 5, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

17

510(k) Premarket Notification - Traditional

Image /page/17/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is set against a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: ER4-9 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 7, 8, 12, 13
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 8, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (Cardiac)
		Other (spec.)
	Peripheral
Vessel	Peripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

18

510(k) Premarket Notification - Traditional

Image /page/18/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L4-7 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 2, 5, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K182894; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate

• Note 14: Tissue Doppler Imaging (TDI)

19

510(k) Premarket Notification - Traditional

Image /page/19/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is set against a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LS6-15 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	N	N	N		N	Note 1	Notes 2, 5, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
& Vessel	Peripheral vessel	P	P	P		P	Note 1	Notes 7, 8, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K182894; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate

• Note 14: Tissue Doppler Imaging (TDI)

20

510(k) Premarket Notification - Traditional

Image /page/20/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside a blue, rounded, oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: SP3-8 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal (See Note 13)
	Trans-vaginal (See Note 13)
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7, 14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7, 14
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K133505; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, B+PPI, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+TD, B+DPD)

• Note 2: Includes imaging for guidance of biopsy
  Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: Tissue Doppler Imaging (TDI)

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

21

510(k) Premarket Notification - Traditional

Image /page/21/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: DP8B for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 12)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K181336; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for quidance of biopsy

Note 3: Includes infertility monitoring of follicle development

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate Note 14: Tissue Doppler Imaging (TDI)

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

22

510(k) Premarket Notification - Traditional K191055

5. 510(K) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

• Date Prepared April 17, 2019 1.
• 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
• 3. Primary Contact Person Scully KIM Requlatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail]
• 4. Secondary Contact Person Roberto Cunha Director of Regulatory & Quality Phone: [phone] Email: [e-mail]
• 5. Proposed Device
  • Proprietary Name: HS40 Diagnostic Ultrasound System
  • Common Name: System, Imaging, Pulsed Doppler, Ultrasonic System, Imaging, Pulsed Echo, Ultrasonic Transducer, Ultrasonic, Diagnostic - Classification:
    • 21 CFR 892.1550 Ultrasonic pulsed doppler imaging system 21 CFR 892.1560 Ultrasonic pulsed echo imaging system 21 CFR 892.1570 Diagnostic ultrasonic transducer
  • Product Code(s): IYN, IYO, ITX

6. Predicate Device

HS40 Diagnostic Ultrasound System (K180409) - Primary Predicate HS50/60 Diagnostic Ultrasound System (K181336) SONOACE R7 Diagnostic Ultrasound System (K133505) HM70A Diagnostic Ultrasound System (K182894)

• 7. Device Description
     The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS40 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both

23

510(k) Premarket Notification - Traditional

automatically displayed.

• 8. Intended Use
     The HS40 ultrasound diagnostic system and probes are designed to obtain ultrasound images and analvze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

• 9. Technology
     The HS40 employs the same fundamental scientific technology as its predicate device.
• 10. Determination of Substantial Equivalence
      Comparison to Predicate: The HS40 is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

• . The systems are all intended for diagnostic ultrasound imaging and fluid flow analvsis

• The HS40 and predicate HS40(K180409) have the same clinical intended use. .

• The HS40 and predicate HS40(K180409) have the same imaging modes and . modes of operation.

• . The HS40 added some of SW features (2DNT, BiometryAssist, E-Strain, NeedleMate, AutoIMT, etc.) that migrated from predicate HS50/60 (K181336)

• The transducers L4-7, LS6-15, SP3-8, DP8B are previously cleared in the . predicates HM70A(K182894), SONOACE R7 (K133505) and HS50/60 (K181336).

• . The system is manufactured with materials which have been evaluated and found to be safe for the intended use of the device.

• The system has acoustic power levels which are below the applicable FDA limits.

• The HS40 and predicate HS40(K180409) have similar capability in terms of . performing measurements, capturing digital images, reviewing and reporting studies.

• . The HS40 and predicate have been designed in compliance with approved electrical and physical safety standards.

• 11. Summary of Non-Clinical Test

The device has been evaluated for acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable FDA guidance and medical device safety standards. The HS40 and its applications comply with the following FDA-recognized standards.

Reference No.	Title
---------------	-------

24

510(k) Premarket Notification - Traditional

| IEC 60601-1 | AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance (IEC
60601-1:2005, MOD) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | IEC60601-1-2: 2014(4th Edition) , Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - EMC |
| IEC 60601-2-37 | IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment |
| ISO10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk management process |
| ISO14971 | ISO 14971:2007, Medical devices - Application of risk management to
medical devices |
| NEMA UD 2-2004 | NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment Revision 3 |
| NEMA UD 3-2004 | NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output
Indices on Diagnostic Ultrasound Equipment, Revision 2 |

• 12. Summary of Clinical Tests
      The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence.
• 13. Conclusion
      Since the predicates device and subject device have a similar intended use and key technological features, the non-clinical data support the safety of the device and demonstrate that the HS40 Ultrasound System should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. concludes that the performance of the subject device is as safe and effective, and is therefore substantially equivalent, to the predicate device(s) that are currently marketed for the same intended use..
• 14. Recall History of Predicates Any of the predicates of the subject device has been recalled.

END of 510(K) Summary .