HM70A Diagnostic Ultrasound System by Samsung Medison Co., Ltd.

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

Device Description

The HM70A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode. M mode, Color Doppler imaging, Power Doppler imaging(including Directional Power Doppler mode; S-Flow), PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70A 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 HM70A has 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 the study proving the device meets them, based on the provided FDA 510(k) summary for the HM70A Diagnostic Ultrasound System:

Summary of Acceptance Criteria and Device Performance

The acceptance criteria for the HM70A Diagnostic Ultrasound System are primarily tied to its substantial equivalence to previously cleared predicate devices. The core argument for acceptance is that the proposed device, HM70A V3.00, maintains the same safety and effectiveness as its predicate, HM70A V2.00 (K153408), and that newly added transducers or functionalities are comparable to those cleared in other predicates.

Acceptance Criterion (Implicit)	Reported Device Performance and Supporting Evidence
Intended Use Equivalence	The HM70A V3.00 has the same clinical intended use as the primary predicate HM70A V2.00 (K153408). This is explicitly stated. The device is intended for "diagnostic ultrasound imaging and fluid analysis of the human body" across a wide range of clinical applications.
Technological Equivalence (Core System)	The proposed HM70A Diagnostic Ultrasound System and the primary predicate device HM70A (K153408) "employ the same fundamental scientific technology as all of the features are migrated from the predicate." This implies that existing performance characteristics, image quality, and processing capabilities are maintained.
Imaging Mode Equivalence	The HM70A V3.00 and predicate HM70A V2.00 (K153408) have the same imaging modes and modes of operation (2D mode, M mode, Color Doppler imaging, Power Doppler imaging, PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode, Elastoscan Mode).
Transducer Equivalence	New transducers (CA2-9AD, P4-12, LS3-14B) are added. The CA2-9AD was previously cleared in HS50/60 (K170493) and P4-12 in UGEO PT60A (K142466). The new LS3-14B transducer's substantial equivalence was "discussed and the Image Performance test report and Biocompatibility test report are attached in Appendix." (Note: The reports themselves are not in the provided text).
Needle Guidance Equivalence (for specific features)	"The Needle Pilot and eZGuide of the predicate eZono 4000 (K140254) have same intended use for similar clinical applications; the similarity has been evaluated to be substantial equivalence."
Material Safety	"The system is manufactured with materials which have been evaluated and found to be safe for the intended use of the device."
Acoustic Output Limits Compliance	"The system has acoustic power levels which are below the applicable FDA limits." The device displays Mechanical Index (MI) and Thermal Index (TI).
Measurement, Capture, Review & Reporting Capability	"The HM70A V3.00 and predicate systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies."
Electrical and Physical Safety Standards Compliance	"The HM70A V3.00 and predicate systems have been designed in compliance with approved electrical and physical safety standards." (e.g., ANSI AAMI ES60601-1:2005, IEC60601-1-2: 2014, IEC60601-2-37:2007).
Biocompatibility (for new transducers)	Biocompatibility testing for new transducers was not needed as the transducers were migrated from previously cleared systems.
Cleaning and Disinfection Effectiveness	Reprocessing validation for new transducers was not needed as the transducers were migrated from previously cleared systems.
Software/Firmware-driven Functionality (Image Quality)	"All Migrated probes and software functionality were evaluated using the same test criteria as the predicates for all applicable imaging modes to ensure that migration from a 128-channel system to 128-channel system did not compromise image quality with respect to the intended use of each feature." This evaluation followed FDA guidance documents.
Risk Management Application	Compliance with ISO 14971:2007.

Study Details from the 510(k) Summary:

The provided document is a 510(k) summary, which is a premarket notification for demonstrating substantial equivalence rather than a detailed clinical study report for a novel AI device. Therefore, many of the typical AI/ML study components (like expert ground truth establishment, MRMC studies, training set details) are not applicable or not explicitly detailed in this type of submission.

Here's what can be extracted based on the information provided:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: Not explicitly stated in terms of a specific number of images or cases. The evaluation relies on "non-clinical tests" and demonstrates equivalence to previously cleared devices.
- Data Provenance: Not specified. The document states "All transducers proposed in the present submission were migrated from previously cleared systems," and "All Migrated probes and software functionality were evaluated using the same test criteria as the predicates for all applicable imaging modes." This implies that the testing leveraged existing validation methodologies for diagnostic ultrasound systems rather than a novel AI algorithm tested on a specific dataset. The company's origin is Republic of Korea.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable in the context of this 510(k) summary. The submission focuses on substantial equivalence based on technical, safety, and performance characteristics compared to predicates, not on a new diagnostic algorithm requiring human expert ground truth for interpretation. Diagnostic ultrasound systems inherently involve human operators (competent health care professionals) making diagnoses.
Adjudication Method for the Test Set:
- Not applicable. See point 2.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- No, an MRMC comparative effectiveness study was explicitly NOT done. The "Summary of Clinical Tests" section states: "The subject of this premarket submission, HM70A, is not required clinical studies to support substantial equivalence." This means no human-in-the-loop study comparing performance with and without AI assistance was performed or required for this submission.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, an algorithm-only standalone performance study was not performed as part of this submission. This is a diagnostic ultrasound system, which is an imaging device. The "algorithm" here refers to the underlying signal processing and image formation techniques, not a separate AI-based diagnostic algorithm that would typically undergo standalone performance testing. The evaluation focuses on physical and electrical safety, acoustic output, and demonstration that migrated features maintain image quality similar to predicates.
The Type of Ground Truth Used:
- Not applicable in the typical sense of AI/ML ground truth. For this type of device (a diagnostic ultrasound system), "ground truth" for performance is established through technical specifications, phantom testing, and comparisons to the performance of previously cleared devices. The "Indications for Use" section establishes the clinical applications for which the device is intended to be used by trained healthcare professionals for diagnosis.
The Sample Size for the Training Set:
- Not applicable. This submission is for a conventional diagnostic ultrasound system, not an AI/ML product developed with large training datasets. The "software/Firmware-driven Functionality" was evaluated to ensure image quality was not compromised, which implies testing existing software and probes rather than training a new algorithm.
How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 7.

Summary

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

Re: K182894

Trade/Device Name: HM70A Diagnostic Ultrasound System LS3-14B Transducer

Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 12, 2018 Received: December 28, 2018

Dear Scully Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

January 22, 2019

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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 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.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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)

K182894

Device Name HM70A Diagnostic Ultrasound System

Indications for Use (Describe)

The HM70A 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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510(k) Premarket Notification - Traditional

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: HM70A 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	P	P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 12)	P	P	P	P	P	Note 1	Notes 2, 4, 7, 8, 9, 10, 11
	Intra-operative (See Note 6)	P	P	P		P	Note 1	Note 7, 8, 9, 11
	Intra-operative (Neuro.)	P	P	P		P	Note 1	Note 7, 8, 9, 11
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 10, 11
	Neonatal Cephalic	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 10, 11
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 10, 11
	Trans-urethral
	Trans-esoph. (non-Cardiac)	P	P	P	P	P	Note 1	Note 4, 7
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.) (See Note 13)	P	P	P		P	Note 1	Note 2, 7, 8, 10, 11
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note 1	Note 4, 7
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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510(k) Premarket Notification - Traditional

Image /page/4/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is placed inside a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: SC1-6 for use with HM70A

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	P	Note 1	Notes 4, 7, 8, 9
	Abdominal (See Note 12)	P	P	P	P	P	Note 1	Notes 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 7, 8, 9
	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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510(k) Premarket Notification - Traditional

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-6 for use with HM70A

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	P	Note 1	Notes 2, 4, 7, 8, 9
	Abdominal (See Note 12)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	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	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging
Note10: ElastoScan
Note11: MultiVision (old name: Spatial Compound Imaging)
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate

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

Image /page/6/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CF4-9 for use with HM70A

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	P	Note 1	Notes 2, 7, 8, 9
	Abdominal (See Note 12)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 9: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

Note 8: 3D imaging

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510(k) Premarket Notification - Traditional

Image /page/7/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EVN4-9 for use with HM70A

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, 11
	Abdominal (See Note 12)	P	P	P		P	Note 1	Note 2, 7, 10, 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	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 10, 11
	Trans-vaginal	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 10, 11
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)	P	P	P	P	P	Note 1	Note 2, 7, 10, 11
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 9: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

Note 8: 3D imaging

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510(k) Premarket Notification - Traditional

Image /page/8/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L4-7 for use with HM70A

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)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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: Panoramic imaging
Note10: ElastoScan
Note11: MultiVision (old name: Spatial Compound Imaging)
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate

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

{9}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/9/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L5-13 for use with HM70A

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	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 10, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/10/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L7-16 for use with HM70A

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	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging
Note10: ElastoScan
Note11: MultiVision (old name: Spatial Compound Imaging)
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate

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

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

510(k) Premarket Notification - Traditional

Image /page/11/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PE2-4 for use with HM70A

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

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: P3-8 for use with HM70A

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

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: VN4-8 for use with HM70A

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 1	Note 2, 7, 8
	Abdominal (See Note 12)	P	P	P		P	Note 1	Note 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
& Other	Pediatric	P	P	P		P	Note 1	Note 2, 7, 8
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging
Note10: ElastoScan
Note11: MultiVision (old name: Spatial Compound Imaging)
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CW2.0 for use with HM70A

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)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging
Note10: ElastoScan
Note11: MultiVision (old name: Spatial Compound Imaging)
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate

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

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

510(k) Premarket Notification - Traditional

Image /page/15/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CW4.0 for use with HM70A

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				P
	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.) (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+C+PW, B+PD+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, 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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/16/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is enclosed in a blue, oval-shaped background. The logo is simple and recognizable.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: CA1-7AD for use with HM70A

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	P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 12)	P	P	P	P	P	Note 1	Notes 2, 4, 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.)	P	P	P	P	P	Note 1	Notes 2, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Notes 2, 7, 9, 11
	Intra-luminal
	Other (spec.) (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 K153408 ; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+PD+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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/17/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is enclosed in a blue, oval-shaped background. The logo is simple and recognizable.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: LA3-16AD for use with HM70A

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		P	Note 1	Note 2, 5, 6, 7, 9, 10, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
	PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1
Other (spec.)

N= new indication; P= previously cleared by FDA K153408 ; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+B 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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/18/Picture/2 description: The image shows the Samsung logo. The logo is white text on a blue background. The text is in all capital letters and is in a sans-serif font.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: DP2B for use with HM70A

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)
	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 (spec.) (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA-K153408 ; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+PD+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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/19/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is bold and sans-serif, and the letters are evenly spaced. The blue oval is slightly tilted, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LS6-15 for use with HM70A

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)	P	P	P		P	Note 1	Note 7, 8, 9, 11b
	Intra-operative (Neuro.)	P	P	P		P	Note 1	Note 7, 8, 9, 11b
Fetal Imaging	Laparoscopic
&	Pediatric
Other	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	Note 7, 9, 11a
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 7, 9, 11a
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	Note 1	Note 7, 9, 11a
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153408 ; 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+C+PW, B+C+PW, B+PD+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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: V5-9 for use with HM70A

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

N= new indication; P= previously cleared by FDA K153408 ; 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+C+PW, B+C+PW, B+PD+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, 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: Panoramic imaging

Note10: ElastoScan

Note11: MultiVision (old name: Spatial Compound Imaging)

Note12: Includes Renal, Gynecology/Pelvis

Note13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/21/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. The oval is tilted slightly upwards from left to right.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: CV1-8AD for use with HM70A

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.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Note 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 4, 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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408 ; 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+C+PW, B+PD+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 (MultiVision (old name: Spatial Compound Imaging))

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/22/Picture/2 description: The image shows the Samsung logo. The logo is a blue oval with the word "SAMSUNG" in white letters. The word is written in a sans-serif font. The logo is simple and modern.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: MMPT3-7 for use with HM70A

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	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)	P	P	P	P	P	Note 1	Note 4, 7
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note 1	Note 4, 7
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	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+CW, B+C+PW, B+C+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 (MultiVision (old name: Spatial Compound Imaging))

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/23/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is enclosed in a blue, oval shape. The logo is simple and recognizable.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-9AD for use with HM70A

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
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		Note 15	Note 1	Notes 2, 6, 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.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P		Note 15	Note 1	Notes 2, 7, 9, 11
	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+CW, B+C+PW, B+C+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+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, 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 (MultiVision (old name: Spatial Compound Imaging))

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/24/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is inside of a blue, oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: P4-12 for use with HM70A

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 8)	P	P	P		P	Note 1	Note 2, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging&Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 7
	Small Organ (See Note 5)
	Neonatal Cephalic	N	N	N		N	Note 1	Note 2, 7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 10)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Note 2, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 2, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K142466 ; 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+C+PW, B+C+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, 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 (MultiVision (old name: Spatial Compound Imaging))

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

Image /page/25/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is set against a blue, oval-shaped background.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LS3-14B for use with HM70A

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 8)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (See Note 10)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared ; 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+C+PW, B+C+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, 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 (MultiVision (old name: Spatial Compound Imaging))

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

510(k) Premarket Notification - Traditional

5. 510(K) Summary

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

Date Prepared Oct 12, 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 Scully KIM Requlatory Affairs Specialist Phone: +82.2.2194.1312 Fax: +82.31.8017.9573 Email: scully.kim@samsungmedison.com
1. Secondary Contact Person Roberto Cunha Director of Regulatory & Quality Phone: +1.978.564.8503 Email: rcunha@samsungneurologica.com
1. Proposed Device
Proprietary Name: HM70A Diagnostic Ultrasound System
Common Name: System, Imaging, Pulsed Doppler, Ultrasonic ।
- System, Imaging, Pulsed Echo, Ultrasonic
  - Transducer, Ultrasonic, Diagnostic
Classification : 21 CFR 892.1550 Ultrasonic pulsed doppler imaging system -
- 21 CFR 892.1560 Ultrasonic pulsed echo imaging system
- 21 CFR 892.1570 Diagnostic ultrasonic transducer
Product Code(s): IYN, IYO, ITX -
1. Predicate Device
- HM70A Diagnostic Ultrasound System (K153408) -
- -UGEO PT60A Diagnostic Ultrasound System (K142466)
- HS50/60 Diagnostic Ultrasound System (K170493) -
- eZono 4000 (K140254) -

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

1. Device Description
  The HM70A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode. M mode, Color Doppler imaging, Power Doppler imaging(including Directional Power Doppler mode; S-Flow), PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70A 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 HM70A has real time

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

510(k) Premarket Notification - Traditional

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

1. Indications for Use
  The HM70A 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, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel.

The indications for use of the proposed device are the same as the primary predicate HM70A (K153408). Therefore, the proposed device does not raise new questions of safety and effectiveness

1. Technological Comparison to Predicate Devices The proposed HM70A Diagnostic Ultrasound System and the currently marketed predicate device HM70A (K153408) employ the same fundamental scientific technology as all of the features are migrated from the predicate.
1. Determination of Substantial Equivalence

Comparison to Predicate: The HM70A is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

The systems are all intended for diagnostic ultrasound imaging and fluid flow ● analvsis
The HM70A V3.00 and predicate HM70A V2.00 (K153408) have the same clinical intended use.
The HM70A V3.00 and predicate HM70A V2.00 (K153408) have the same ● imaging modes and modes of operation.
The transducers CA2-9AD, P4-12 and LS3-14B are added in this submission. . The CA2-9AD previously cleared in the predicate HS50/60 (K1170493) and P4-12 previously cleared in the predicate UGEO PT60A (K142466). The new transducer LS3-14B is added in this submission. The substantial

equivalence has been discussed and the Image Performance test report and Biocompatibility test report are attached in Appendix.

. The Needle Pilot and eZGuide of the predicate eZono 4000 (K140254) have same intended use for similar clinical applications; the similarity has been evaluated to be substantial Equivalence.
The system is manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
The system has acoustic power levels which are below the applicable FDA limits. ●
The HM70A V3.00 and predicate HM70A V2.00 have similar capability in terms of . performing measurements, capturing digital images, reviewing and reporting studies.
The HM70A V3.00 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
1. Summary of Non-Clinical Test

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical

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

510(k) Premarket Notification – Traditional

safety, and has been found to conform with applicable medical device safety standards.

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

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices - Application of riskmanagement to medical devices
Electrical Safety	The HM70A Ultrasound System with defibrillation-proof ECGelectrode 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: General Requirements forbasic safety and essential performance.
ElectromagneticCompatibility	IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment --Part 1-2: General Requirements For Basic Safety And EssentialPerformance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests
Software/Firmware-driven Functionality	All Migrated probes and software functionality were evaluated usingthe same test criteria as the predicates for all applicable imagingmodes to ensure that migration from a 128-channel system to 128-channel system did not compromise image quality with respect tothe intended use of each feature.Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices issued on May 11, 2005Information for Manufacturers Seeking Marketing Clearance ofDiagnostic Ultrasound Systems and Transducers issued September9, 2008
Ultrasound Safety	IEC60601-2-37:2007 + A1:2015, Particular requirements for thesafety of ultrasonic medical diagnostic and monitoring equipmentNEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for Diagnostic UltrasoundEquipment Revision 3NEMA UD 3-2004 (R2009)Standard for Real-Time Display of Thermal and Mechanical AcousticOutput Indices on Diagnostic Ultrasound Equipment, Revision 2

12. Summary of Clinical Tests

The subject of this premarket submission, HM70A, is not required clinical studies to support substantial equivalence.

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

510(k) Premarket Notification – Traditional

1. Conclusion
  Since the predicate device and subject device have a similar intended use and key technological features, the non-clinical data support the safety of the device and demonstrate that the HM70A Diagnostic Ultrasound System should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. concludes that the performance of the subject device is as safe and effective, and is therefore substantially equivalent, to the predicate device that 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.