HS50 / HS60 Diagnostic Ultrasound System by Samsung Medison Co., Ltd.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Samsung Medison HS50/HS60 Diagnostic Ultrasound System, based on the provided document:

1. Table of Acceptance Criteria & Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it states that the device was evaluated to conform with applicable FDA guidance and medical device safety standards and that migrated probes and software functionalities were evaluated using the same test criteria as the predicates to ensure that migration from a 192-channel system to a 128-channel system did not compromise image quality with respect to the intended use of each feature. This implies that the acceptance criteria are tied to maintaining performance parity or non-inferiority with predicate devices and adhering to recognized safety and performance standards for diagnostic ultrasound systems.

The reported device performance is generally described qualitatively as being "as safe and effective" and "substantially equivalent" to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of patient data. The non-clinical testing appears to be based on engineering evaluations, phantom studies, and possibly existing data from the predicate devices.

Sample Size: Not explicitly stated for a "test set" of patient data.
Data Provenance: The testing is primarily non-clinical, involving evaluations of acoustic output, software function, thermal, electrical, electromagnetic, and mechanical safety. The transducers were "migrated from previously cleared systems," suggesting that their performance characteristics were already established. If patient data was used for evaluating image quality related to "migration from a 192-channel system to 128-channel system," the document does not specify its origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable as the primary testing described is non-clinical and doesn't explicitly involve human expert evaluation of a "test set" of images for diagnostic accuracy against a ground truth in the context of a clinical study. The document mentions "competent health care professionals" use the device for diagnosis, but not in the context of establishing ground truth for the device's own performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is primarily non-clinical and doesn't involve clinical cases requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The document explicitly states: "The proposed device HS50 / HS60 Ultrasound System, did not require clinical studies to demonstrate substantial equivalence."

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes evaluations for specific software functionalities such as "E-Strain, Stress Echo, 2D NT, Crystal Vue, 5D Heart Color, BiometryAssist, HQ Vision, and S-Detect for Breast Lite." It states these 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." This implies that the performance of these functionalities themselves was assessed, which could be considered standalone in how the algorithm generates data or images. However, it's not a standalone diagnostic performance study for a specific clinical outcome.

7. The Type of Ground Truth Used

For the non-clinical tests (acoustic output, safety, etc.), the "ground truth" would be the established engineering specifications, safety standards (e.g., IEC, NEMA), and the performance characteristics of the predicate devices. For software functionalities, the ground truth would likely involve technical benchmarks and comparison to outputs from the predicate devices or established methods. There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for this submission.

8. The Sample Size for the Training Set

Not applicable. This submission is for a diagnostic ultrasound system and its transducers, not for a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software functionalities" mentioned are likely embedded algorithms and features, but the document doesn't detail their development or training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI algorithm.

Summary

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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

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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

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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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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	ColorDoppler*	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.)
PeripheralVessel	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	ColorDoppler*	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.)
PeripheralVessel	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	ColorDoppler*	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.)
PeripheralVessel	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+

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510(k) Premarket Notification - Traditional

Image /page/6/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The 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: 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	ColorDoppler*	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.)
PeripheralVessel	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	ColorDoppler*	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.)
PeripheralVessel	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	ColorDoppler*	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.)
PeripheralVessel	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)

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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	ColorDoppler*	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.)
PeripheralVessel	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)

{10}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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)

{11}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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+

{12}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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)

{13}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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)

{14}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/14/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, 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	ColorDoppler*	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.)
PeripheralVessel	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)

{15}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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)

{16}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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)

{17}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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)

{18}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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)

{19}------------------------------------------------

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	ColorDoppler*	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.)
PeripheralVessel	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)

{20}------------------------------------------------

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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	ColorDoppler*	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.)
PeripheralVessel	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)

{21}------------------------------------------------

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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	ColorDoppler*	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.)
PeripheralVessel	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+

{22}------------------------------------------------

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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	ColorDoppler*	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

{23}------------------------------------------------

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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	ColorDoppler*	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.)

PeripheralVessel	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+

{24}------------------------------------------------

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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	ColorDoppler*	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

{25}------------------------------------------------

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	ColorDoppler*	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.)

PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

{26}------------------------------------------------

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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	ColorDoppler*	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.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

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

Additional Comments:

{27}------------------------------------------------

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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:

{28}------------------------------------------------

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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

{29}------------------------------------------------

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:

{30}------------------------------------------------

510(k) Premarket Notification – Traditional

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Feature	HS50/ HS60(Proposed Device)	HS50/ HS60(K170493;Primary PredicateDevice)	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 asRS85(K173204)	Same as HS50/HS60 (K170493)
Scanhead Types:	Same	- Linear Array- Curved LinearArray- Endocavity- Phased Array- Static Probes	Same	Same	Same
ScanheadFrequency	Same	1.0 ~ 20.0 MHz	Same	Same	Same
Acoustic OutputDisplay & FDALimits:	Same	- Display Feature for- Higher Output-Track3- MI Output Display	Same	Same	Same
Feature	HS50/ HS60(Proposed Device)	HS50/ HS60(K170493;Primary PredicateDevice)	RS85(K173204)	WS80A(K173513)	HS40(K180409)
Modes ofOperation:	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
#TransmitChannels	Same as HS50/HS60 (K170493)	128	192	Same asRS85(K173204)	64
#ReceiveChannels	Same as HS50/HS60 (K170493)	128	192	Same asRS85(K173204)	64
510(k) Track	Same	Track 3	Same	Same	Same
SystemCharacteristics:	Same as HS50/HS60 (K170493)with Li-ion BackupBattery and BatteryAssist function	- Beamformer 128- Mobile cart- LCD Monitor- 256 gray shadeson monitor	- Beamformer 192- Mobile cart- LCD Monitor (LEDBacklight unit)- 256 gray shades	Same asRS85(K173204)	Same as HS50/HS60 (K170493)
Feature	HS50/ HS60(Proposed Device)	HS50/ HS60(K170493;Primary PredicateDevice)	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 imagepresentation	- 3D imagepresentation	- 3D imagepresentation	- 3D imagepresentation	- 3D imagepresentation
	- (3D Cine/4D Cine)	- (3D Cine/4DCine)	- (3D Cine/4DCine)	- (3D Cine/4DCine)	- (3D Cine/4DCine)
	- 3D Rendering(MPR)	- 3D Rendering(MPR)	- 3D Rendering(MPR)	- 3D Rendering(MPR)	- 3D Rendering(MPR)
	- 3D XI- (MSV, ObliqueView)	- 3D XI- (MSV, ObliqueView)	- 3D XI- (MSV,ObliqueView)	- 3D XI- (MSV, ObliqueView)	- 3D XI- (MSV, ObliqueView)
	- Volume CT	- Volume CT	- Volume CT	- Volume CT	- Volume CT
	- 3D MagiCut	- 3D MagiCut	- 3D MagiCut	- 3D MagiCut	- 3D MagiCut
	- VolumeCalculation(VOCAL, XIVOCAL)	- VolumeCalculation(VOCAL, XIVOCAL)	- VolumeCalculation(VOCAL, XIVOCAL)	- VolumeCalculation(VOCAL, XIVOCAL)	- VolumeCalculation(VOCAL, XIVOCAL)
	- XI STIC	- XI STIC	- XI STIC	- XI STIC	- XI STIC
	- Quick Scan (QScan)	- Quick Scan (QScan)	- Quick Scan (QScan)	- Quick Scan (QScan)	- Quick Scan (QScan)
	- 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+	- NeedleMate+	- Needle Mate+	- Needle Mate+
	- Realistic Vue	- Realistic Vue	- Realistic Vue	- Realistic Vue	- Realistic Vue
Feature	HS50/ HS60(Proposed Device)	HS50/ HS60(K170493;Primary PredicateDevice)	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 forBreast (Lite)	-	- S-Detect forBreast (Lite)	- S-Detect forBreast (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 PredicateDevice)	RS85(K173204)	WS80A(K173513)	HS40(K180409)
				SC1-6
	[Phased array]PE2-4PA1-5APA4-12BPA3-8B	[Phased array]PE2-4PA1-5APA3-8B	[Phased array]PM1-6APA3-8BPA4-12B	[Phased array]PA3-8BPE2-4PM1-6APA4-12B	[Phased array]PN2-4
	[Endo Cavity]EA2-11BER4-9VR5-9EVN4-9	[Endo Cavity]EA2-11BER4-9	[Endo Cavity]E3-12AEA2-11B	[Endo Cavity]E3-12AVR5-9EA2-11B	[Endo Cavity]EVN4-9
[3D]	[3D]CV1-8ADV5-9	[3D]CV1-8ADV5-9	[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]DP2BCW6.0DP8B	[Pencil]DP2BCW6.0	[Pencil]DP2BCW6.0DP8B	[Pencil]	[Pencil]DP2B
	[TEE]MMPT3-7		[TEE]MMPT3-7
Biopsy guides	BP-KIT-024-3BP-KIT-029BP-KIT-054 [BP-KIT-054-NG]BP-KIT-055 [BP-KIT-055-NG]BP-KIT-060	BP-KIT-024-3BP-KIT-029BP-KIT-054 [BP-KIT-054-NG]BP-KIT-055 [BP-KIT-055-NG]BP-KIT-060	BP-KIT-029BP-KIT-030BP-KIT-043BP-KIT-053BP-KIT-054BP-KIT-055	BP-KIT-009BP-KIT-012BP-KIT-028BP-KIT-029- BP-KIT-030- BP-KIT-041	BP-KIT-024BP-KIT-029BP-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 PredicateDevice)	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 optionaldevices	- Digital B/W VideoPrinter- Digital ColorVideo Printer- USB Printer- DVD recorder(DVR)	- Digital B/W VideoPrinter- Digital ColorVideo Printer- USB Printer- DVD recorder(DVR)	- Digital B/W VideoPrinter- Digital ColorVideo Printer- USB Printer- DVD recorder(DVR)	- Digital B/W VideoPrinter- Digital Color VideoPrinter- USB Printer- DVD recorder(DVR)	- Digital B/W VideoPrinter- Digital ColorVideo 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 PredicateDevice)	RS85(K173204)	WS80A(K173513)	HS40(K180409)
			System Stand-WLAN Card

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510(k) Premarket Notification – Traditional

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510(k) Premarket Notification – Traditional

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510(k) Premarket Notification – Traditional

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510(k) Premarket Notification – Traditional

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510(k) Premarket Notification – Traditional

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510(k) Premarket Notification – Traditional

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

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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 backupbattery and Battery Assist feature and defibrillation-proofECG 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)2012Medical Electrical Equipment - Part 1: GeneralRequirements for basic safety and essential performance.IEC 60601-2-18: 2009: Medical electrical equipment - Part2-18: Particular requirements for the basic safety andessential performance of endoscopic equipment
ElectromagneticCompatibility	IEC60601-1-2: 2014(4th Edition) Medical ElectricalEquipment -- Part 1-2: General Requirements For BasicSafety 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 Litewere evaluated using the same test criteria as thepredicates for all applicable imaging modes to ensure thatmigration from a 192-channel system to 128-channel systemdid not compromise image quality with respect to theintended use of each feature.Clinical applications of E-strain were expanded to includebreast, prostate, small organs, and musculoskeletal with arestriction on use for evaluating bone.The Battery Assist function was tested to ensure that thesystem enters and promptly exits from a sleep state enabledby the software and Li-ion backup battery
	Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices issued on May 11,2005
	Information for Manufacturers Seeking Marketing Clearanceof Diagnostic Ultrasound Systems and Transducers issuedSeptember 9, 2008
	IEC60601-2-37:2007 + A1:2015, Particular requirements forthe safety of ultrasonic medical diagnostic and monitoringequipment
Ultrasound Safety	NEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for DiagnosticUltrasound Equipment Revision 3
	NEMA UD 3-2004 (R2009)Standard for Real-Time Display of Thermal and MechanicalAcoustic Output Indices on Diagnostic UltrasoundEquipment, Revision 2

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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.

END of 510(K) Summary -

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.