K Number

Device Name

HS50 / HS60 Diagnostic Ultrasound System

Manufacturer

Samsung Medison Co., Ltd.

Date Cleared

2018-12-04

(197 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

The HS50 / HS60 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 Trans-esophageal(Cardiac), and peripheral vessel.

Device Description

The HS50 / HS60 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 / HS60 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 HS50 / HS60 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The HS50 / HS60 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K170493, K173204, K173513, K180409

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that are characteristic of AI/ML, such as training or test sets for algorithms. While it mentions features like "BiometryAssist" and "S-Detect for Breast Lite," the description of their evaluation focuses on image quality and functionality migration, not on the performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity).

Therapeutic

No
The device is described 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 making a diagnosis. It does not perform any therapeutic intervention.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the "Device Description" states that it "is a general purpose, mobile, software controlled, diagnostic ultrasound system."

SaMD (Software as a Medical Device)

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:

Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes an imaging device used to visualize internal structures and analyze fluids within the body.
Device Description: The description details an ultrasound system that acquires and displays ultrasound data in various modes. It also mentions measurement and analysis packages that provide information for diagnosis. This aligns with the function of an imaging device.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside the body to obtain information about a patient's health. This device does not mention the analysis of in vitro samples.

Therefore, the HS50 / HS60 Diagnostic Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HS50 / HS60 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 Trans-esophageal(Cardiac), and peripheral vessel.

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

IYN, IYO, ITX

Device Description

The HS50 / HS60 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 Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac), and Peripheral vessel.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic 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 Trans-esophageal(Cardiac), and peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

competent health care professionals

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 HS50 / HS60 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.

HS50/HS60 Diagnostic Ultrasound System (K170493), RS85 Diagnostic Ultrasound System (K173204), WS80A Diagnostic Ultrasound System (K173513), 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

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

Samsung Medison Co., Ltd. Ji Yea Lee Regulatory Affairs Specialist 3366. Hanseo-ro. Nam-myeon. HONGCHEON-GUN, GANGWON-DO 25108 REPBLIC OF KOREA

Re: K181336

Trade/Device Name: HS50 / HS60 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: November 02, 2018 Received: November 05, 2018

Dear Ji Yea Lee:

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

December 4, 2018

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181336

Device Name

HS50 / HS60 Diagnostic Ultrasound System

Indications for Use (Describe)

The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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.

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"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)

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

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510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: HS50/HS60 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		Note 15	Note 1	Note 2,3,4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	Note 15	Note 1	Note 2,6, 7, 8, 9, 11, 12, 16
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	Note 15	Note 1	Note 2, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11, 12
	Neonatal Cephalic	P	P	P	P	Note 15	Note 1	Note 2, 7, 8, 9, 11
	Adult Cephalic	P	P	P	P	Note 15	Note 1	Note 2, 7, 8, 9, 11
	Trans-rectal	P	P	P		Note 15	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-vaginal	P	P	P		Note 15	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11, 12
	Musculo-skel. (Superfic.)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11
	Intra-luminal
	Other (See Note 13)	P	P	P		Note 15	Note 1	Notes 2, 7, 8, 9, 11, 12
Cardiac	Cardiac Adult	P	P	P	P	Note 15	Note 1	Note 4, 7, 14, 17
	Cardiac Pediatric	P	P	P	P	Note 15	Note 1	Note 4, 7, 14, 17
	Trans-esophageal (Cardiac)	P	P	P	P	Note 15	Note 1	Note 4, 7, 14, 17
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	Note 15	Note 1	Note 2, 6, 7, 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+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, DuallQuad,

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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA3-14AD for use with HS60/ HS50

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)	P	P	P		Note 15	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		Note 15	Note 1	Note 2, 7, 9, 11, 12
	Musculo-skel. (Superfic.)	P	P	P		Note 15	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		Note 15	Note 1	Note 2, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; 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+DD+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, 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)

Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 16: Contrast

Note 17: Strain+

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510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA1-7AD for use with HS50/HS60

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		Note 15	Note 1	Notes 2, 7, 9, 11
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Notes 2, 7, 9, 11, 16
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	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		Note 15	Note 1	Notes 2, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		Note 15	Note 1	Notes 2, 7, 9, 11
	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 K170493; 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+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)

Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 16: Contrast Note 17: Strain+

510(k) Premarket Notification - Traditional

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CF4-9 for use with HS50/HS60

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		Note 15	Note 1	Notes 9, 11
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Notes 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		Note 15	Note 1	Notes 6, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 9, 11
	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	P	P	P		Note 15	Note 1	Notes 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

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510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: ER4-9 for use with HS50/HS60

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/Obstetrics (See Note 3)	P	P	P		Note 15	Note 1	Notes 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		Note 15	Note 1	Notes 2, 7, 9, 12
	Trans-vaginal	P	P	P		Note 15	Note 1	Notes 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		Note 15	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 K170493; 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+DD+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, 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)

Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 16: Contrast

Note 17: Strain+

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510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA3-16A for use with HS50/HS60

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 (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)	P	P	P		Note 15	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		Note 15	Note 1	Note 2,7,9,11,12
	Musculo-skel. (Superfic.)	P	P	P		Note 15	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		Note 15	Note 1	Note 2, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo is a blue oval with the word "SAMSUNG" written in white letters inside. The logo is simple and recognizable. The font is sans-serif and the letters are evenly spaced.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA3-16AI for use with HS50/HS60

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 (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	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		Note 15	Note 1	Note 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		Note 15	Note 1	Note 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		Note 15	Note 1	Note 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/10/Picture/1 description: The image shows the Samsung logo. The logo is in blue and white. The word "SAMSUNG" is written in white letters on a blue background. The background is an oval shape.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA2-9A for use with HS50/HS60

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		Note 15	Note 1	Note 2, 7, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		Note 15	Note 1	Note 2, 7, 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		Note 15	Note 1	Note 2, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/11/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PA3-8B for use with HS50/HS60

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 15	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	Note 15	Note 1	Note 6, 7
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	Note 15	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	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, 14,17
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7, 14, 17
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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)
Note 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

Image /page/12/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PE2-4 for use with HS50/HS60

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 15	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 15	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	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, 14,17
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7, 14, 17
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/13/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed on a blue, oval-shaped background.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CV1-8AD for use with HS50/HS60

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		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Note 2, 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 FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

510(k) Premarket Notification - Traditional

Image /page/14/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The text is set against a blue, oval-shaped background. The logo is slightly tilted.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: V5-9 for use with HS50/HS60

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		Note 15	Note 1	Note 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P		Note 15	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		Note 15	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P		Note 15	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		Note 15	Note 1	Note 2, 7, 8, 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 K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/15/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: DP2B for use with HS50/HS60

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/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 Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/16/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CW6.0 for use with HS50/HS60

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/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 Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/17/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed on a blue, oval-shaped background.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-9AD for use with HS50/HS60

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 15	Note 1	Notes 2, 7, 9, 11
	Abdominal (See Note 12)	P	P	P	P	Note 15	Note 1	Notes 2, 7, 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 FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/18/Picture/1 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 sans-serif and bold, giving the logo a clean and modern look. The blue oval is slightly tilted, adding a dynamic element to the design.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EA2-11B for use with HS60

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		Note 15	Note 1	Note 2, 7, 9
	Abdominal (See Note 12)	P	P	P		Note 15	Note 1	Note 2, 7, 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		Note 15	Note 1	Note 2, 7, 9, 12
	Trans-vaginal	P	P	P		Note 15	Note 1	Note 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	Note 2, 7, 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 K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/19/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA4-18BD for use with HS60

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)	P	P	P		Note 15	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		Note 15	Note 1	Note 2, 7, 9, 11, 12
	Musculo-skel. (Superfic.)	P	P	P		Note 15	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		Note 15	Note 1	Note 2, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/20/Picture/1 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. The oval is tilted slightly, giving the logo a dynamic appearance.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PA1-5A for use with HS60

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)	P	P	P	P	Note 15	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	Note 15	Note 1	Note 7
	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	P	P	P	Note 15	Note 1	Note 4, 7, 14, 17
	Cardiac Pediatric	P	P	P	P	Note 15	Note 1	Note 4, 7, 14, 17
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K170493; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, 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 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 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast Note 17: Strain+

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

Image /page/21/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA3-10A for use with HS60

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, 3, 4, 7, 9,
	Abdominal (See Note 12)	P	P	P		P	Note 1	Notes 2, 6, 7, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 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	Note 1	Notes 2, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 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	Note 1	Notes 2, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K173204, ; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+CW, 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) Note 15: Color Doppler includes Power (Amplitude) Doppler Note 16: Contrast Note 17: Strain+

Image /page/22/Picture/1 description: The image shows the Samsung logo. The logo is in a blue oval shape with the word "SAMSUNG" in white, bold letters. The logo is simple and recognizable.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-6BM for use with HS50/HS60

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)	P	P	P		Note 15	Note 1	Notes 2, 7, 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 FDA K180409 ; E= added under Appendix E

Additional Comments:

Image /page/23/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: VR5-9 for use with HS60

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
	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, 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	Notes 2, 7, 8, 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 K173513; 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+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) Note 15: Color Doppler includes Power (Amplitude) Doppler Note 16: Contrast Note 17: Strain+

Image /page/24/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EVN4-9 for use with HS50

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		Note 15	Note 1	Note 2, 7, 9
	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
	Trans-rectal	P	P	P		Note 15	Note 1	Note 2, 7, 9, 12
	Trans-vaginal	P	P	P		Note 15	Note 1	Note 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	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:

Image /page/25/Picture/1 description: The image shows the Samsung logo. The logo is in a blue oval shape with the word "SAMSUNG" in white, bold letters. The logo is simple and recognizable, and it is often used on Samsung products and in advertising.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PA4-12B for use with HS50/HS60

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)	P	P	P	P	P	Note 1	Note 2,15
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 2,15
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Note 2,15
	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	P	P	P	P	P	Note 1	Note 4, 7,15
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7,15
	Trans-esophageal (Cardiac)
	Other (spec.)

Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E

Additional Comments:

Image /page/26/Picture/1 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.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: DP8B for use with HS60

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
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E

Additional Comments:

Image /page/27/Picture/1 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. The logo is simple and modern.

510(k) Premarket Notification - Traditional

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: MMPT3-7 for use with HS50/HS60

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	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 12)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note 1	Note 4, 7,14, 17
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E

Additional Comments:

Image /page/28/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The wordmark is set against a blue, rounded, oval-shaped background.

510(k) Premarket Notification – Traditional

510(K) Summary: K181336

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

Date Prepared November 30, 2018 1.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, HONGCHEON-GUN, GANGWON-DO 25108 REPUBLIC OF KOREA
1. Primary Contact Person Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2194.1594 Fax: +82.2.556.3974 Email: jiyea722.lee@samsungmedison.com
1. Proposed Device
- Proprietary Name: HS50/HS60 Diagnostic Ultrasound System
- System, Imaging, Pulsed Doppler, Ultrasonic - Common Name: 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 5.
- HS50/HS60 Diagnostic Ultrasound System (K170493); primary predicate
- RS85 Diagnostic Ultrasound System (K173204)
- WS80A Diagnostic Ultrasound System (K173513)
- HS40 Diagnostic Ultrasound System (K180409)

The predicates have not been the subject of a design-related recall.

Device Description 6.
The HS50 / HS60 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 / HS60 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 HS50 / HS60 have real time acoustic

510(k) Premarket Notification - Traditional

Image /page/29/Picture/2 description: The image shows the Samsung logo. The logo is in white text on a blue oval background. The text is in a bold, sans-serif font. The logo is simple and recognizable.

output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The HS50 / HS60 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 Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac), and Peripheral vessel.

1. Indications for Use
  The HS50 / HS60 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, Transvaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Trans-esophageal(Cardiac), and peripheral vessel.

The indications for use of the proposed device is not the same as the primary predicate HS50/HS60 (K170493) due to the additional supporting application of Trans-esophageal (Cardiac). However, the predicate RS85 (K173204) has the same indications for use and is the same submission from which the corresponding TEE probe was migrated. Therefore, the proposed device has similar indications for use compared to the predicates that does not raise different questions of safety and effectiveness.

8. Technological Comparison to Predicate Devices

The proposed HS50/HS60 Diagnostic Ultrasound System and the currently marketed predicate device(s), HS50/HS60(K170493), RS85(K173204), HS40(K180409) and WS80A(K173513), employ the same fundamental scientific technology. The differences are the addition of software features, transducers and supporting biopsy guides.

A comparison of the proposed HS50/HS60 Diagnostic Ultrasound System to the currently marketed and predicates, HS50/HS60(K170493), RS85(K173204), WS80A(K173513) and HS40(K180409) is provided in the Table below:

510(k) Premarket Notification – Traditional

Image /page/30/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters. The letters are inside of a blue oval.

| Feature | HS50/ HS60
(Proposed Device) | HS50/ HS60
(K170493;
Primary Predicate
Device) | RS85
(K173204) | WS80A
(K173513) | 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
Transesophageal | - 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
Transesophageal | Same as
RS85
(K173204) | Same as HS50/
HS60 (K170493) |
| Scanhead Types: | Same | - Linear Array
Curved Linear
Array
Endocavity
Phased Array
Static Probes | Same | Same | Same |
| Scanhead
Frequency | Same | 1.0 ~ 20.0 MHz | Same | Same | Same |
| Acoustic Output
Display & FDA
Limits: | Same | - Display Feature for
Higher Output-
Track3
MI Output Display | Same | Same | Same |
| Feature | HS50/ HS60
(Proposed Device) | HS50/ HS60
(K170493;
Primary Predicate
Device) | RS85
(K173204) | WS80A
(K173513) | HS40
(K180409) |
| Modes of
Operation: | Same | - TI Output Display
B-mode
M-mode
Color Doppler
Pulsed wave
(PW) Doppler
Continuous wave
(CW) Doppler
Power Amplitude
Doppler
Elastoscan
3D imaging
Combination
Modes
Pulse Inversion
Harmonic
Imaging
Tissue Harmonic
Imaging | Same | Same | Same |
| #Transmit
Channels | Same as HS50/
HS60 (K170493) | 128 | 192 | Same as
RS85
(K173204) | 64 |
| #Receive
Channels | Same as HS50/
HS60 (K170493) | 128 | 192 | Same as
RS85
(K173204) | 64 |
| 510(k) Track | Same | Track 3 | Same | Same | Same |
| System
Characteristics: | Same as HS50/
HS60 (K170493)
with Li-ion Backup
Battery and Battery
Assist function | - Beamformer 128
Mobile cart
LCD Monitor
256 gray shades
on monitor | - Beamformer 192
Mobile cart
LCD Monitor (LED
Backlight unit)
256 gray shades | Same as
RS85
(K173204) | Same as HS50/
HS60 (K170493) |
| Feature | HS50/ HS60
(Proposed Device) | HS50/ HS60
(K170493;
Primary Predicate
Device) | RS85
(K173204) | WS80A
(K173513) | HS40
(K180409) |
| | | - 100-120V, 60 Hz; | on monitor | | |
| | | - 200-240V, 50 Hz | - 100-240VAC,
1100VA, 50/60Hz | | |
| Functionality | - 3D Imaging | - 3D Imaging | - 3D Imaging | - 3D Imaging | - 3D Imaging |
| | - 3D image
presentation | - 3D image
presentation | - 3D image
presentation | - 3D image
presentation | - 3D image
presentation |
| | - (3D Cine/4D Cine) | - (3D Cine/4D
Cine) | - (3D Cine/4D
Cine) | - (3D Cine/4D
Cine) | - (3D Cine/4D
Cine) |
| | - 3D Rendering
(MPR) | - 3D Rendering
(MPR) | - 3D Rendering
(MPR) | - 3D Rendering
(MPR) | - 3D Rendering
(MPR) |
| | - 3D XI
(MSV, Oblique
View) | - 3D XI
(MSV, Oblique
View) | - 3D XI
(MSV,
Oblique
View) | - 3D XI
(MSV, Oblique
View) | - 3D XI
(MSV, Oblique
View) |
| | - Volume CT | - Volume CT | - Volume CT | - Volume CT | - Volume CT |
| | - 3D MagiCut | - 3D MagiCut | - 3D MagiCut | - 3D MagiCut | - 3D MagiCut |
| | - Volume
Calculation
(VOCAL, XI
VOCAL) | - Volume
Calculation
(VOCAL, XI
VOCAL) | - Volume
Calculation
(VOCAL, XI
VOCAL) | - Volume
Calculation
(VOCAL, XI
VOCAL) | - Volume
Calculation
(VOCAL, XI
VOCAL) |
| | - XI STIC | - XI STIC | - XI STIC | - XI STIC | - XI STIC |
| | - Quick Scan (Q
Scan) | - Quick Scan (Q
Scan) | - Quick Scan (Q
Scan) | - Quick Scan (Q
Scan) | - Quick Scan (Q
Scan) |
| | - ClearVision | - ClearVision | - ClearVision | - ClearVision | - ClearVision |
| | - MultiVision | - MultiVision | - MultiVision | - MultiVision | - MultiVision |
| | - Auto IMT+ | - Auto IMT+ | - Auto IMT+ | - Auto IMT+ | - Auto IMT+ |
| | - Elastoscan | - Elastoscan | - Elastoscan | - Elastoscan | - Elastoscan |
| | - Panoramic | - Panoramic | - Panoramic | - Panoramic | - Panoramic |
| | - Needle Mate+ | - Needle Mate+ | - Needle
Mate+ | - Needle Mate+ | - Needle Mate+ |
| | - Realistic Vue | - Realistic Vue | - Realistic Vue | - Realistic Vue | - Realistic Vue |
| Feature | HS50/ HS60
(Proposed Device) | HS50/ HS60
(K170493;
Primary Predicate
Device) | RS85
(K173204) | WS80A
(K173513) | HS40
(K180409) |
| | - 5D Follicle | - 5D Follicle | - 5D Follicle | - 5D Follicle | - 5D Follicle |
| | - 5D NT | - 5D NT | - 5D NT | - 5D NT | - 5D NT |
| | - Strain + | - Strain + | - Strain + | - MPI | - Strain + |
| | - CEUS+ | - CEUS+ | - CEUS+ | - ADVR | |
| | - E-Strain | - | - E-Strain | - E-Strain | |
| | - Stress Echo | - | - Stress Echo | | |
| | - 2D NT | - | - 2D NT | - 2D NT | |
| | - Crystal Vue | - | | - Crystal Vue | |
| | - 5D Heart Color | - | | - 5D Heart Color | |
| | - BiometryAssist | - | | - BiometryAssist | |
| | - HQ Vision | - | - HQ Vision | - E-Cervix | |
| | - S-Detect for
Breast (Lite) | - | - S-Detect for
Breast (Lite) | - S-Detect for
Breast (Lite) | |
| Transducer | [Linear array]
LA3-14AD
LA2-9A
LA4-18BD
LA3-16A
LA3-16AI | [Linear array]
LA3-14AD
LA2-9A
LA3-16AI
LA4-18BD
LA3-16A | [Linear array]
L3-12A
LA2-9A
LA3-16AI
LA3-16A
LA4-18B
LM4-15B | [Linear array]
L3-12A
L5-13
LA2-9A
LA3-16A
LA3-16AI
LA4-18B
LM4-15B | [Linear array]
LA3-16AD
LN5-12
L5-12/50 |
| | [Curved array]
CA1-7AD
CA2-9AD
CF4-9
CA3-10A
CA2-6BM | [Curved array]
CA1-7AD
CA2-9AD
CF4-9 | [Curved array]
CA1-7A
CA2-8A
CF4-9
CA3-10A | [Curved array]
C2-6
CA1-7A
CA2-8A
CA2-9A
CA3-10A
CF4-9 | [Curved array]
CA2-8AD
CF4-9
C2-8
C2-5
CA2-6BM |
| Feature | HS50/ HS60
(Proposed Device) | HS50/ HS60
(K170493;
Primary Predicate
Device) | RS85
(K173204) | WS80A
(K173513) | HS40
(K180409) |
| | | | | SC1-6 | |
| | [Phased array]
PE2-4
PA1-5A
PA4-12B
PA3-8B | [Phased array]
PE2-4
PA1-5A
PA3-8B | [Phased array]
PM1-6A
PA3-8B
PA4-12B | [Phased array]
PA3-8B
PE2-4
PM1-6A
PA4-12B | [Phased array]
PN2-4 |
| | [Endo Cavity]
EA2-11B
ER4-9
VR5-9
EVN4-9 | [Endo Cavity]
EA2-11B
ER4-9 | [Endo Cavity]
E3-12A
EA2-11B | [Endo Cavity]
E3-12A
VR5-9
EA2-11B | [Endo Cavity]
EVN4-9 |
| [3D] | [3D]
CV1-8AD
V5-9 | [3D]
CV1-8AD
V5-9 | [3D]
V5-9
LV3-14A
CV1-8A
EV3-10B | [3D]
CV1-8A
LV3-14A
V4-8
V5-9
EV3-10B | [3D]
VN4-8 |
| [Pencil] | [Pencil]
DP2B
CW6.0
DP8B | [Pencil]
DP2B
CW6.0 | [Pencil]
DP2B
CW6.0
DP8B | [Pencil] | [Pencil]
DP2B |
| | [TEE]
MMPT3-7 | | [TEE]
MMPT3-7 | | |
| Biopsy guides | BP-KIT-024-3
BP-KIT-029
BP-KIT-054 [BP-
KIT-054-NG]
BP-KIT-055 [BP-
KIT-055-NG]
BP-KIT-060 | BP-KIT-024-3
BP-KIT-029
BP-KIT-054 [BP-
KIT-054-NG]
BP-KIT-055 [BP-
KIT-055-NG]
BP-KIT-060 | BP-KIT-029
BP-KIT-030
BP-KIT-043
BP-KIT-053
BP-KIT-054
BP-KIT-055 | BP-KIT-009
BP-KIT-012
BP-KIT-028
BP-KIT-029
BP-KIT-030
BP-KIT-041 | BP-KIT-024
BP-KIT-029
BP-KIT-049 [BP-
KIT-049-NG]
BP-KIT-054 [BP-
KIT-054-NG]
BP-KIT-055 [BP- |
| Feature | HS50/ HS60
(Proposed Device) | HS50/ HS60
(K170493;
Primary Predicate
Device) | RS85
(K173204) | WS80A
(K173513) | HS40
(K180409) |
| | - BP-KIT-061
BP-KIT-068 [BP-
KIT-068-NG]
BP-KIT-043
BP-KIT-053 [BP-
KIT-053-NG]
BP-KIT-058 [BP-
KIT-058-NG]
BP-KIT-059 [BP-
KIT-059-NG]
BP-KIT-065
BP-KIT-066
BP-KIT-069 | - BP-KIT-061
BP-KIT-068 [BP-
KIT-068-NG]
BP-KIT-043
BP-KIT-053 [BP-
KIT-053-NG]
BP-KIT-058 [BP-
KIT-058-NG]
BP-KIT-059 [BP-
KIT-059-NG]
BP-KIT-065
BP-KIT-066
BP-KIT-069 | - BP-KIT-057
BP-KIT-058
BP-KIT-059
BP-KIT-060
BP-KIT-067
BP-KIT-068
BP-KIT-069
BP-KIT-071
BP-KIT-075 | - BP-KIT-043
BP-KIT-052
BP-KIT-053
BP-KIT-054
BP-KIT-055
BP-KIT-057
BP-KIT-058
BP-KIT-059
BP-KIT-060
BP-KIT-065
BP-KIT-066
BP-KIT-068
BP-KIT-069
BP-KIT-071
BP-KIT-075 | KIT-055-NG]
BP-KIT-060
BP-KIT-061
BP-KIT-068 [BP-
KIT-068-NG] |
| On board optional
devices | - Digital B/W Video
Printer
Digital Color
Video Printer
USB Printer
DVD recorder
(DVR) | - Digital B/W Video
Printer
Digital Color
Video Printer
USB Printer
DVD recorder
(DVR) | - Digital B/W Video
Printer
Digital Color
Video Printer
USB Printer
DVD recorder
(DVR) | - Digital B/W Video
Printer
Digital Color Video
Printer
USB Printer
DVD recorder
(DVR) | - Digital B/W Video
Printer
Digital Color
Video Printer
USB Printer
DVD recorder
(DVR) |
| Etc. | - Digital Storage/
Transfer Station
Foot Switch
ECG
Gel Warmer | - Digital Storage/
Transfer Station
Foot Switch
ECG
Gel Warmer | - Digital Storage
/Transfer Station
Foot Switch
ECG
Gel Warmer
Clear Track/
Virtual Track | - Digital Storage/
Transfer Station
Foot Switch
ECG
Gel Warmer
WLAN Card | - Digital Storage/
Transfer Station
Foot Switch
ECG
Gel Warmer |
| Feature | HS50/ HS60
(Proposed Device) | HS50/ HS60
(K170493;
Primary Predicate
Device) | RS85
(K173204) | WS80A
(K173513) | HS40
(K180409) |
| | | | System Stand
-WLAN Card | | |

510(k) Premarket Notification – Traditional

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K181336 - Page 4 of 11

510(k) Premarket Notification – Traditional

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510(k) Premarket Notification – Traditional

Image /page/33/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters. The letters are inside of a blue oval.

K181336 - Page 6 of 11

510(k) Premarket Notification – Traditional

Image /page/34/Picture/2 description: The image shows the SAMSUNG logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.

510(k) Premarket Notification – Traditional

Image /page/35/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters. The letters are inside of a blue oval.

510(k) Premarket Notification – Traditional

Image /page/36/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.

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

Image /page/37/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters. The background is a blue oval shape.

510(k) Premarket Notification – Traditional

Summary of Non-Clinical Testing 9.
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.

All transducers proposed in the present submission were migrated from previously cleared systems. Therefore, additional biocompatibility testing and reprocessing validation was not needed.

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices -
Application of risk management to medical devices
Electrical Safety	The HS50/HS60 Ultrasound System with Li-ion backup
battery and Battery Assist feature and 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.
IEC 60601-2-18: 2009: Medical electrical equipment - Part
2-18: Particular requirements for the basic safety and
essential performance of endoscopic equipment
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
Software/Firmware-
driven Functionality	Migrated probes and software functionality including E-Strain, Stress Echo, 2D NT, Crystal Vue, 5D Heart Color,
BiometryAssist, HQ Vision, and S-Detect for Breast Lite
were evaluated using the same test criteria as the
predicates for all applicable imaging modes to ensure that
migration from a 192-channel system to 128-channel system
did not compromise image quality with respect to the
intended use of each feature.
Clinical applications of E-strain were expanded to include
breast, prostate, small organs, and musculoskeletal with a
restriction on use for evaluating bone.
The Battery Assist function was tested to ensure that the
system enters and promptly exits from a sleep state enabled
by the software and Li-ion backup battery
	Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices issued on May 11,
2005
	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
Ultrasound Safety	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

Image /page/38/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed on a blue, rounded, rectangular background.

510(k) Premarket Notification - Traditional

10. Summary of Clinical Tests

The proposed device HS50 / HS60 Ultrasound System, did not require clinical studies to demonstrate substantial equivalence.

11. Conclusion

Since the predicate devices 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 HS50 / HS60 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.

Intended Use / Indications for Use

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

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

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.

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).

§ 892.1550 Ultrasonic pulsed doppler imaging system.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K181336

Indications for Use (Describe)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

Additional Comments:

510(K) Summary: K181336

8. Technological Comparison to Predicate Devices

10. Summary of Clinical Tests

11. Conclusion

END of 510(K) Summary -