HS30 Diagnostic Ultrasound System

• K Number: K182632
• Device Name: HS30 Diagnostic Ultrasound System
• Manufacturer: Samsung Medison Co., Ltd.
• Date Cleared: 2019-01-08 ( 106 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The HS30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. 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 HS30 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, Elastoscan Mode or as a combination of these modes. The HS30 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 HS30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The HS30 uses digital multi-beam forming technology and supports a variety of Linear, Convex, Phased, Static and Volume probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz.

Predicate Devices

K180409

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and measurement functions without mentioning any AI/ML capabilities.

Therapeutic

No.
The device is clearly stated as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging and fluid analysis," and its function is to "acquire ultrasound data and to display the data" for diagnosis, not treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The HS30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the "Device Description" section refers to it as a "diagnostic ultrasound system" and mentions that it offers "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" and mentions supporting various "Linear, Convex, Phased, Static and Volume probes," which are hardware components essential for ultrasound imaging. While it is software-controlled, it is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The HS30 Diagnostic Ultrasound System is described as a device that uses ultrasound waves to create images of the inside of the human body. It acquires ultrasound data and displays it in various imaging modes.
• Intended Use: The intended use is for "diagnostic ultrasound imaging and fluid analysis of the human body." This refers to imaging the body directly, not analyzing samples taken from the body.
• Device Description: The description focuses on the ultrasound technology, imaging modes, and measurement functions, all of which are related to in-vivo imaging.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.

Therefore, the HS30 Diagnostic Ultrasound System is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HS30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The HS30 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, Elastoscan Mode or as a combination of these modes. The HS30 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 HS30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The HS30 uses digital multi-beam forming technology and supports a variety of Linear, Convex, Phased, Static and Volume probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz.

Mentions image processing

Not Found

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 clinical applications)

Intended User / Care Setting

Competent health care professionals (implied by "make a diagnosis by competent health care professionals"). Mobile cart system implies hospital or clinic use.

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 proposed device HS30 Diagnostic Ultrasound System did not require clinical studies to demonstrate substantial equivalence.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

HS40 Diagnostic Ultrasound System (K180409)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Samsung Medison Co., Ltd. Jee Young Ju Regulatory Affairs Specialist 3366. Hanseo-ro. Nam-myeon. Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA

Re: K182632

Trade/Device Name: HS30 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: December 7, 2018 Received: December 10, 2018

Dear Jee Young Ju:

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

January 8, 2019

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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 (if known) K182632

Device Name HS30 Diagnostic Ultrasound System

Indications for Use (Describe)

The HS30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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)

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."

FORM FDA 3881 (7/17)

3

510(k) Premarket Notification - Traditional

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: HS30 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	N	N	N	N	N	N	N
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 10, 11
	Intra-operative (See Note 6)	N	N	N	N	N	N
	Intra-operative (Neuro.)	N	N	N	N	N	N
	Laparoscopic	N	N	N	N	N	N
	Pediatric	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 11
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2, 7, 9, 11, 12
	Neonatal Cephalic	N	N	N	N	N	Note 1	Note 8, 9, 11
	Adult Cephalic	N	N	N	N	N	Note 1	Note 7
	Trans-rectal	N	N	N	N	N	Note 1	Note 2, 7, 9, 12, 13
	Trans-vaginal	N	N	N	N	N	Note 1	Note 2, 7, 9, 12
	Trans-urethral	N	N	N	N	N	N	N
	Trans-esoph. (non-Cardiac)	N	N	N	N	N	N	N
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 11, 12
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Note 2, 7, 9, 11
	Intra-luminal	N	N	N	N	N	N	N
	Other (See Note 13)	N	N	N	N	N	Note 1	Note 2, 7, 9, 12
Cardiac	Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7, 14
	Cardiac Pediatric	N	N	N	N	N	Note 1	Note 4, 7, 14
	Trans-esophageal (Cardiac)	N	N	N	N	N	N	N
	Other (spec.)	N	N	N	N	N	N	N
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 11
	Other (spec.)	N	N	N	N	N	N	N

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+CW, 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 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)

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 background is a blue oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CF4-9 for use with HS30

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 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	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	Note 1	Notes 7, 8, 9, 11
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	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+CW, 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 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)

5

510(k) Premarket Notification - Traditional

Image /page/5/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The logo is simple and recognizable, and it is associated with the Samsung brand.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PN2-4 for use with HS30

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+Elastoscan, B+C+PW, B+PD+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 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)

Note 2: Includes imaging for guidance of biopsy

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 letters. The background is a blue, rounded oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EVN4-9 for use with HS30

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)
	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, 13
	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+Elastoscan, B+C+PW, B+PD+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)

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7

510(k) Premarket Notification - Traditional

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: DP2B for use with HS30

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 12)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	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+CW, 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 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)

8

510(k) Premarket Notification - Traditional

Image /page/8/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 oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-8 for use with HS30

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, 4, 7,8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 6, 7, 8, 9,10, 11
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	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+CW, 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 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)

9

510(k) Premarket Notification - Traditional

Image /page/9/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: C2-5 for use with HS30

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, 10, 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 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:

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+TD+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 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 letters on a blue oval background. The logo is simple and recognizable, and it is often used on Samsung products and in advertising.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LN5-12 for use with HS30

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)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	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	Cardiac Adult
	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+CW, 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 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)

11

510(k) Premarket Notification - Traditional

Image /page/11/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, 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: L5-12/50 for use with HS30

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)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	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	Cardiac Adult
	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+CW, 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 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)

12

510(k) Premarket Notification - Traditional

Image /page/12/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The font is sans-serif and bold, giving the logo a clean and modern appearance. The oval shape is slightly tilted, adding a dynamic element to the design.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: ER4-9 for use with HS30

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	Notes 2, 7, 8
	Abdominal (See Note 10)
	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	Notes 2, 7, 9, 12, 13
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 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	Notes 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:

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+TD+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 imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

13

5. 510(K) Summary: K182632

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

• Date Prepared December 07, 2018 1.
• 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
• Primary Contact Person 3. Jee Young Ju 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: HS30 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 -
• Predicate Device 6.
  • HS40 Diagnostic Ultrasound System (K180409) -

The predicate has not been the subject of a design-related recall.

• 7. Device Description
     The HS30 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, Elastoscan Mode or as a combination of these modes. The HS30 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 HS30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The HS30 uses digital multi-beam forming technology and supports a variety of Linear, Convex, Phased, Static and Volume probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult

14

Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

• Indications for Use 8.
  The HS30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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.

The indications for use of the proposed device are the same as the predicate HS40 (K180409) except Intra-Operative application.

Since the proposed device HS30 does not support the Intra-Operative application for any of the transducers, it does not raise new questions of safety and effectiveness.

9. Technological Comparison to Predicate Devices

The proposed HS30 Diagnostic Ultrasound System and the currently marketed predicate device HS40 (K180409), employ the same fundamental scientific technology as all of the features are migrated from the predicate.

A comparison of the proposed HS30 Diagnostic Ultrasound System to the currently marketed and predicates HS40 (K180409) is provided in the Table below:

| Feature | HS30
(Under Review) | HS40
(K180409) |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | - Fetal/Obstetrics

• Abdominal
• Gynecology
• Pediatric
• Small Organ
• Neonatal Cephalic
• Adult Cephalic
• Trans-rectal
• Trans-vaginal
• Musculo-skel. (Conventional)
• Musculo-skel. (Superficial)
• Urology
• Cardiac Adult
• Cardiac Pediatric
• Peripheral vessel | - Fetal/Obstetrics
• Abdominal
• Gynecology
• Pediatric
• Small Organ
• Neonatal Cephalic
• Adult Cephalic
• Trans-rectal
• Trans-vaginal
• Musculo-skel. (Conventional)
• Musculo-skel. (Superficial)
• Urology
• Cardiac Adult
• Cardiac Pediatric
• Peripheral vessel
• Intra-Operative |
  | Scanhead Types: | - Linear Array
• Curved Linear Array
• Endocavity
• Phased Array
• Static Probes | - Linear Array
• Curved Linear Array
• Endocavity
• Phased Array
• Static Probes |
  | Scanhead Frequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz |
  | Acoustic Output
  Display & FDA
  Limits: | - Display Feature for Higher Output-Track3
• MI Output Display
• TI Output Display | - Display Feature for Higher Output-Track3
• MI Output Display
• TI Output Display |
  | Modes of Operation: | - B-mode
• M-mode
• Color Doppler
• Pulsed wave (PW) Doppler | - B-mode
• M-mode
• Color Doppler
• Pulsed wave (PW) Doppler |
  | Feature | HS30
  (Under Review) | HS40
  (K180409) |
  | | - Power Amplitude Doppler | - Power Amplitude Doppler |
  | | - Elastoscan | - Elastoscan |
  | | - Combination Modes | - Combination Modes |
  | | - S-Harmonic (Pulse Inversion Harmonic Imaging) | - Pulse Inversion Harmonic Imaging |
  | | - Tissue Harmonic Imaging | - Tissue Harmonic Imaging |
  | | - 3D imaging | - 3D imaging |
  | #Transmit Channels | 64 | 64 |
  | #Receive Channels | 64 | 64 |
  | 510(k) Track | Track 3 | Track 3 |
  | System
  Characteristics: | - Beamformer 128 | - Beamformer 128 |
  | | - Mobile cart | - Mobile cart |
  | | - LED Monitor | - LED Monitor |
  | | - 256 gray shades on monitor | - 256 gray shades on monitor |
  | | - 100-120V, 60 Hz; | - 100-120V, 60 Hz; |
  | | - 200-240V, 50 Hz | - 200-240V, 50 Hz |
  | Functionality | - DICOM | - DICOM |
  | | - Quick Scan (Q Scan) | - Quick Scan (Q Scan) |
  | | - ClearVision | - ClearVision |
  | | - MultiVision | - MultiVision |
  | | - Auto IMT+ | - Auto IMT+ |
  | | - Elastoscan | - Elastoscan |
  | | - Panoramic | - Panoramic |
  | | - Needle Mate+ | - Needle Mate+ |
  | | - Strain + | - Strain + |
  | | - EZ-Exam+ | - EZ-Exam+ |
  | | - Mobile Export | - Mobile Export |
  | | - 3D Imaging
  (Freehand 3D) | - 3D Imaging
  (Freehand 3D) |
  | | - 3D Rendering (MPR) | - 3D Rendering (MPR) |
  | | - 3D MagiCut | - 3D MagiCut |
  | | | Volume Calculation
  (VOCAL, XI VOCAL) |
  | | | - 3D XI
  (MSV, Oblique View) |
  | | | - 5D Folicle |
  | | | - 5D NT |
  | | | - Realistic Vue |
  | | | - XI-STIC |
  | Transducers | [Linear array]
  -LN5-12
  -L5-12/50 | [Linear array]
  -LN5-12
  -L5-12/50
  -LA3-16AD |
  | | [Curved array]
  -CF4-9
  -C2-8
  -C2-5 | [Curved array]
  -CF4-9
  -C2-8
  -C2-5
  -CA2-8AD
  -CA2-6BM |
  | | [Endo Cavity]
  -EVN4-9
  -ER4-9 | [Endo Cavity]
  -EVN4-9
  -ER4-9 |
  | | [Phased array]
  PN2-4 | [Phased array]
  PN2-4 |
  | | [CW] | [CW] |
  | Feature | HS30
  (Under Review) | HS40
  (K180409) |
  | | DP2B | DP2B |
  | | | [3D] |
  | | | VN4-8 |
  | | | V5-9 |
  | Biopsy guides | - BP-KIT-024 | - BP-KIT-024 |
  | | | - BP-KIT-029 |
  | | - BP-KIT-035 [BP-KIT-035-NG] | - BP-KIT-035 [BP-KIT-035-NG] |
  | | - BP-KIT-040 [BP-KIT-040-NG] | - BP-KIT-040 [BP-KIT-040-NG] |
  | | - BP-KIT-045 [BP-KIT-045-NG] | - BP-KIT-045 [BP-KIT-045-NG] |
  | | - BP-KIT-047 [BP-KIT-047-NG] | - BP-KIT-047 [BP-KIT-047-NG] |
  | | | - BP-KIT-049 [BP-KIT-049-NG] |
  | | | - BP-KIT-054 [BP-KIT-054-NG] |
  | | | - BP-KIT-060 |
  | | - BP-KIT-061 | - BP-KIT-061 |
  | | | - BP-KIT-068 [BP-KIT-068-NG] |
  | On board optional
  devices | - Digital B/W Video Printer | - Digital B/W Video Printer |
  | | - Digital Color Video Printer | - Digital Color Video Printer |
  | | - USB Printer | - USB Printer |
  | | - DVD recorder (DVR) | - DVD recorder (DVR) |
  | Etc. | - Digital Storage/ Transfer Station | - Digital Storage/ Transfer Station |
  | | - Foot Switch | - Foot Switch |
  | | - ECG | - ECG |
  | | - Gel Warmer | - Gel Warmer |

15

16

Throughout the comparison to the predicate, the differences in technological characteristics of the proposed device do not raise different questions of safety and effectiveness.

17

10. Summary of Non-Clinical Test

The device has been evaluated for acoustic output and software function as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable FDA guidance and medical device safety standards.

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices - Application of risk
management to medical devices
Electrical Safety	The HS30 Ultrasound System with defibrillation-proof ECG electrode
was evaluated per the following standards.
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,
C1:2009/(R)2012 and A2:2010 /(R)2012
Medical Electrical Equipment - Part 1: General Requirements for
basic safety and essential performance.
Electromagnetic
Compatibility	IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment --
Part 1-2: General Requirements For Basic Safety And Essential
Performance -- Collateral Standard: Electromagnetic Disturbances --
Requirements And Tests
Biocompatibility	ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of
medical devices - Part 1: Evaluation and testing within a risk
management process.
Reprocessing
Medical Devices	FDA Guidance: Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling issued on March 17,
2015, revised June 9, 2017.
Software/Firmware-
driven Functionality	All migrated probes and software functionality were evaluated using
the same test criteria as the predicate for all applicable imaging
modes to ensure that migration into a new system design did not
compromise image quality with respect to the intended use of each
feature.
Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices issued on May 11, 2005
Ultrasound Safety	Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers issued September
9, 2008
IEC60601-2-37:2007 + A1:2015, Particular requirements for the
safety of ultrasonic medical diagnostic and monitoring equipment
NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment Revision 3
NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound Equipment, Revision 2

18

• 11. Summary of Clinical Tests The proposed device HS30 Diagnostic Ultrasound System did not require clinical studies to demonstrate substantial equivalence.

12. Conclusion

Since the predicate 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 HS30 Diagnostic 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 that is currently marketed for the same intended use.