HS50 / HS60 Diagnostic Ultrasound System

• K Number: K170493
• Device Name: HS50 / HS60 Diagnostic Ultrasound System
• Manufacturer: Samsung Medison Co., Ltd.
• Date Cleared: 2017-03-28 ( 39 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, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric 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 and 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.

Predicate Devices

K143264, K162094, K153529, K153408, K163691

Reference Devices

K143264, K162094, K153529, K153408, K163691

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard diagnostic ultrasound system with various imaging modes and analysis packages, but there is no mention of AI or ML technology.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging and fluid analysis." Its function is to acquire and display ultrasound data and provide measurement and analysis packages for diagnosis, not treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the device is "intended for diagnostic ultrasound imaging and fluid analysis of the human body." It also explicitly refers to itself as a "Diagnostic Ultrasound System" in both the "Intended Use" and "Device Description" sections.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducers, imaging system) in addition to software control.

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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The HS50 / HS60 Diagnostic Ultrasound System uses ultrasound waves to create images of structures within the human body. It does not analyze samples taken from the body.
• Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body," referring to imaging of internal structures and potentially fluid collections within the body, not analysis of bodily fluids in a lab setting.
• Device Description: The description focuses on the imaging modalities (B mode, M mode, Doppler, etc.) and measurement/analysis packages applied to the ultrasound images, not to laboratory tests.

Therefore, the HS50 / HS60 is a diagnostic 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, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Product codes

IYN, IYO, ITX

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 and 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.

Mentions image processing

All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulsed doppler imaging system, Ultrasound Pulsed Echo Imaging System

Anatomical Site

Fetal/Obstetrics, Abdominal, Gynecology/Pelvis, Pediatric, Small Organ (for example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, parathyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology/Prostate, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Indicated Patient Age Range

Adult, pediatric, neonatal

Intended User / Care Setting

Not Found

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

The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.

Summary of Clinical Tests: Not applicable. The subject of this submission, HS50 / HS60, did not require clinical studies to support substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

H60 Diagnostic Ultrasound System (K143264), RS80A Diagnostic Ultrasound System (K162094), WS80A Diagnostic Ultrasound System (K153529), HM70A Diagnostic Ultrasound System (K153408), HS70A Diagnostic Ultrasound System (K163691)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three profiles facing to the right, with flowing lines above them. The design is simple and monochromatic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28, 2017

Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313

Re: K170493

Trade/Device Name: HS50 / HS60 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 14, 2017 Received: March 15, 2017

Dear Mr. Job:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara
For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K170493

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.

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

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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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)	N	N	N		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	N	N	N	N	Note 15	Note 1	Note 2, 7, 8, 9, 11, 12, 16
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		Note 15	Note 1	Note 2, 6, 7, 9, 11
	Small Organ (See Note 5)	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11, 12, 17
	Neonatal Cephalic	N	N	N		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Adult Cephalic	N	N	N	N	Note 15	Note 1	Note 2, 7, 8, 9, 11
	Trans-rectal	N	N	N		Note 15	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-vaginal	N	N	N		Note 15	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11, 12, 17
	Musculo-skel. (Superfic.)	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11
	Intra-luminal
	Other (See Note 13)	N	N	N		Note 15	Note 1	Notes 2, 7, 8, 9, 12, 17
	Cardiac Adult	N	N	N	N	Note 15	Note 1	Note 4, 7, 14, 17
Cardiac	Cardiac Pediatric	N	N	N	N	Note 15	Note 1	Note 4, 7, 14, 17
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	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:

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

4

510(k) No.:

Device Name: LA3-14AD 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)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	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	P	Note 15	Note 1	Note 2, 7, 9, 11, 12
	Musculo-skel. (Superfic.)	P	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	P	Note 15	Note 1	Note 2, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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, 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

5

510(k) No.:

Device Name: LA2-9A 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 10)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11
	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
	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 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 K162094; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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, 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

6

510(k) No.:

Device Name: LA3-16AI 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 10)
	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.)	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	Peripheral vessel	P	P	P		Note 15	Note 1	Note 6, 7, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K162094; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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

7

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 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, 17
	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 K162094; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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

8

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/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, 17
	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, 17
	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 K162094; E= added under Appendix E

Additional Comments:

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

9

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 K153408; E= added under Appendix E

Additional Comments:

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

10

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/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
	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)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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, 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

11

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		Note 15	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 (spec.) (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 K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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 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+

12

510(k) No.:

Device Name: ER4-9 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	Notes 2, 7, 9
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	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	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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 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+

13

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/Obstetrics (See Note 3)	P	P	P		Note 15	Note 1	Note 2, 7, 9
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 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		Note 15	Note 1	Note 2, 7, 9, 12, 17
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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 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+

14

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/Obstetrics (See Note 3)
Fetal Imaging
& Other	Abdominal (See Note 10)	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 K163691; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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 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+

15

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	Note 15	Note 1	Note 4, 7, 14, 17
Cardiac	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 K162094; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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, 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

16

510(k) No.:

Device Name: PE2-4 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)
	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 (spec.) (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 K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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 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+

17

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/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.)
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 (spec.) (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 K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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 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+

18

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/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.)
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, 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, 17
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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

19

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

N= new indication; P= previously cleared by FDA K162094; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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 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+

20

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

N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+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, 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

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1. Submitter's Information: 21 CFR 807.92(a)(1)

SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea

Contact Person:

Jiyeon, Cho Regulatory Affairs Specialist

Telephone:	82.2.2194.5431
Facsimile:	82.2.556.3974

Data Prepared: Nov 14, 2016

2. Name of the device:

Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
HS50 / HS60 Diagnostic Ultrasound System
Classification Names:	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasound Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasound Transducer	892.1570	ITX

3. Identification of the predicate or legally marketed device:

• H60 Diagnostic Ultrasound System (K143264) -
• -RS80A Diagnostic Ultrasound System (K162094)
• -WS80A Diagnostic Ultrasound System (K153529)
• HM70A Diagnostic Ultrasound System (K153408) -
• -HS70A Diagnostic Ultrasound System (K163691)

4. 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 and HS60 also gives

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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.

5. Intended Uses:

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 Peripheral vessel.

6. Technological Characteristics:

The HS50 / HS60 are substantially equivalent with respect to safety, effectiveness, and functionality to the H60 (K143264), RS80A (K162094), WS80A (K153529), HM70A (K153408) and HS70A(163691).

All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

Feature /	The subject device		The predicate devices
Characteristics	HS50	HS60	H60
(K143264)	RS80A
(K162094)	WS80A
(K153529)	HM70A
(K153408)	HS70A
(K163691)
Indications for Use
Fetal/Obstetrics	V	V	V	V	V	V	V
Abdominal	V	V	V	V	V	V	V
Gynecology	V	V	V	V	V	V	V
Pediatric	V	V	V	V	V	V	V
Small Organ	V	V	V	V	V	V	V
Neonatal Cephalic	V	V	V	V	V	V	V
Adult Cephalic	V	V	V	V	V	V	V
Trans-rectal	V	V	V	V	V	V	V
Trans-vaginal	V	V	V	V	V	V	V
Musculo-skeletal
(Conventional)	V	V	V	V	V	V	V
Musculo-skeletal
(Superficial)	V	V	V	V	V	V	V
Urology	V	V	V	V	V	V	V
Cardiac Adult	V	V	V	V	V	V	V
Cardiac Pediatric	V	V	V	V	V	V	V
Peripheral vessel	V	V	V	V	V	V	V
Scanhead Types
Linear Array	V	V	V	V	V	V	V
Curved Linear
Array	V	V	V	V	V	V	V
Endocavity	V	V	V	V	V	V	V
Phased Array	V	V	V	V	V	V	V
Static Probes	V	V	V	V	V	V	V
Scanhead Frequency

---------------------------------------------------------------------------	--

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| Feature /

Characteristics	The subject device	The predicate devices
	HS50	HS60	H60
(K143264)	RS80A
(K162094)	WS80A
(K153529)	HM70A
(K153408)	HS70A
(K163691)
1.0 ~ 20.0 MHz	V	V	V	V	V	V	V
Modes of Operation
B-mode	V	V	V	V	V	V	V
M-mode	V	V	V	V	V	V	V
Pulsed wave (PW)
Spectral Doppler	V	V	V	V	V	V	V
Spectral Doppler
Continuous wave
(CW) Doppler	V	V	V	V	V	V	V
Color Doppler	V	V	V	V	V	V	V
Power Amplitude
Doppler	V	V	V	V	V	V	V
Tissue Harmonic
Imaging	V	V	V	V	V	V	V
3D/4D imaging
mode	V	V	V	V	V	V	V
Combined modes	V	V	V	V	V	V	V
Safety & EMC
Compliance
IEC 60601-1
UL 60601-1
CSA C22.2
No.601.1	V	V	V	V	V	V	V
IEC 60601-2-37	V	V	V	V	V	V	V
IEC 60601-1-2	V	V	V	V	V	V	V
Acoustic Output Display Standard
Track 3	V	V	V	V	V	V	V
Patient Contact Materials
Tested to ISO
10993-1	V	V	V	V	V	V	V
Functionality
Quick Scan
(Q Scan)	V	V	V	V	V	V	V
ClearVision	V	V	V	V	V	V	V
MultiVision	V	V	V	V	V	V	V
Needle Mate+	V	V	V	V	V	V	V
Auto IMT+	V	V	V	V	V	V	V
Strain+		V		V			V
Elastoscan	V	V	V	V	V	V	V
Panoramic	V	V	V	V	V	V	V
3D Imaging
(Volume Data
Acquisition)	V	V	V	V	V	V	V
3D Imaging
presentation	V	V	V	V	V	V	V
3D Cine/4D Cine
3D Rendering MPR	V	V	V	V	V	V	V
3D XI	V	V	V	V	V	V	V
3D MSV/Oblique
View	V	V	V	V	V		V
3D MXI Volume
Slice/Mirror View	V	V	V	V	V		V
Volume CT	V	V	V	V	V	V	V
3D MagiCut	V	V	V	V	V	V	V
Volume
Calculation
(VOCAL, XI
VOCAL)	V	V	V	V	V	V	V
XI STIC	V	V	V	V	V	V	V
HDVI		V	V	V	V	V	V
Feature /
Characteristics	The subject device		The predicate devices
	HS50	HS60	H60
(K143264)	RS80A
(K162094)	WS80A
(K153529)	HM70A
(K153408)	HS70A
(K163691)
Realistic Vue	V	V	V	V			V
Ez Exam+	V	V	V	V	V
CEUS+		V		V			V
5D NT	V	V			V		V
5D Follicle	V	V			V		V

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7. A brief discussion of the bench and non-clinical tests conducted on the subject device

The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.

The HS50 / HS60 and their applications comply with voluntary standards as below:

Reference No.	Title
IEC 60601-1	AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment – Part 1-2:
General requirements for basic safety and essential performance – Collateral standard:
Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37	IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
ISO10993-1	ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
ISO10993-5	ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity
ISO10993-10	ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for
irritation and skin sensitization
ISO14971	ISO 14971:2007, Medical devices - Application of risk management to medical
devices
NEMA UD 2-2004	NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
Revision 3
NEMA UD 3-2004	NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment. Revision 2

Summary of Clinical Tests:

Not applicable. The subject of this submission, HS50 / HS60, did not require clinical studies to support substantial equivalence.

8. Conclusion

Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the HS50 / HS60 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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END of 510(K) Summary