HS30 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 Peripheral vessel.

Device Description

The HS30 is a general purpose, mobile, software controlled, diagnostic ultrasound system, Its function is to acquire ultrasound data and to display the data as 2D mode. M mode. Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, Elastoscan Mode or as a combination of these modes. The HS30 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

The acceptance criteria and study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy). Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (HS40 Diagnostic Ultrasound System, K180409) by showing that the new device (HS30 Diagnostic Ultrasound System) has similar intended use and key technological features, and that any differences do not raise new questions of safety or effectiveness.

The "performance" is implicitly demonstrated through adherence to various international and FDA guidance standards related to safety and functionality.

Acceptance Criteria Category	Reported Device Performance (Summary)
Intended Use	Identical to predicate, except exclusion of "Intra-Operative" application (which is deemed not to raise new safety/effectiveness concerns).
Technological Features	Similar to predicate (all features migrated from predicate).
Acoustic Output Safety	Conforms to FDA guidance and IEC60601-2-37, NEMA UD 2, NEMA UD 3.
Electrical Safety	Conforms to ANSI AAMI ES60601-1.
Electromagnetic Compatibility	Conforms to IEC60601-1-2.
Biocompatibility	Conforms to ISO 10993-1.
Reprocessing	Conforms to FDA Guidance for Reprocessing Medical Devices.
Software/Firmware Functionality	Evaluated using the same test criteria as the predicate for all applicable imaging modes to ensure image quality was not compromised.
Risk Management	Assessed per ISO 14971.

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

The document explicitly states: "The proposed device HS30 Diagnostic Ultrasound System did not require clinical studies to demonstrate substantial equivalence." This means there was no specific clinical test set of patient data used for evaluating the device's diagnostic performance from a clinical perspective. The evaluation primarily relied on non-clinical testing and comparison to the predicate device.

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

Not applicable, as no clinical studies with a test set requiring expert ground truth were conducted for this submission. The determination of substantial equivalence was based on non-clinical engineering and safety testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies with a test set requiring expert adjudication were conducted for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states no clinical studies were required to demonstrate substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device is a diagnostic ultrasound system, not an AI algorithm intended for standalone diagnostic performance. Its functionality is to acquire and display ultrasound data for human interpretation. The "software/firmware-driven functionality" was evaluated to ensure image quality and functionality were not compromised compared to the predicate, but this is an assessment of the system's ability to produce expected outputs, not an assessment of an AI algorithm's standalone diagnostic accuracy.

7. The Type of Ground Truth Used

For the non-clinical tests conducted, the "ground truth" would be defined by the specifications and expected outputs of the various tests:

Acoustic Output, Electrical Safety, EMC: Measured values against predefined technical limits and standards.
Biocompatibility: Laboratory test results against established safety thresholds.
Software Functionality: Expected system behavior and image quality output compared to the predicate device's established performance, verified through engineering tests.

8. The Sample Size for the Training Set

Not applicable. The HS30 Diagnostic Ultrasound System is a hardware and software system for generating ultrasound images, not an AI model that requires a training set in the conventional sense. Its development would involve engineering design, manufacturing, and testing processes. The "software functionality" was evaluated against the predicate device, implying a comparison against established benchmarks rather than training.

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

Not applicable, as no AI model requiring a training set was part of this submission for the HS30 Diagnostic Ultrasound System.

Summary

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

Re: K182632

Trade/Device Name: HS30 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 7, 2018 Received: December 10, 2018

Dear Jee Young Ju:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

January 8, 2019

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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

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

510(k) Number (if known) K182632

Device Name HS30 Diagnostic Ultrasound System

Indications for Use (Describe)

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

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)

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510(k) Premarket Notification - Traditional

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: HS30 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic	N	N	N	N	N	N	N
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 10, 11
	Intra-operative (See Note 6)	N	N	N	N	N	N
	Intra-operative (Neuro.)	N	N	N	N	N	N
	Laparoscopic	N	N	N	N	N	N
	Pediatric	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 11
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2, 7, 9, 11, 12
	Neonatal Cephalic	N	N	N	N	N	Note 1	Note 8, 9, 11
	Adult Cephalic	N	N	N	N	N	Note 1	Note 7
	Trans-rectal	N	N	N	N	N	Note 1	Note 2, 7, 9, 12, 13
	Trans-vaginal	N	N	N	N	N	Note 1	Note 2, 7, 9, 12
	Trans-urethral	N	N	N	N	N	N	N
	Trans-esoph. (non-Cardiac)	N	N	N	N	N	N	N
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 11, 12
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Note 2, 7, 9, 11
	Intra-luminal	N	N	N	N	N	N	N
	Other (See Note 13)	N	N	N	N	N	Note 1	Note 2, 7, 9, 12
Cardiac	Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7, 14
	Cardiac Pediatric	N	N	N	N	N	Note 1	Note 4, 7, 14
	Trans-esophageal (Cardiac)	N	N	N	N	N	N	N
	Other (spec.)	N	N	N	N	N	N	N
PeripheralVessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 7, 8, 9, 11
	Other (spec.)	N	N	N	N	N	N	N

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)

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510(k) Premarket Notification - Traditional

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CF4-9 for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

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510(k) Premarket Notification - Traditional

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PN2-4 for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note 1	Note 7
	Trans-rectal (See Note 13)
	Trans-vaginal (See Note 13)
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P		P	Note 1	Note 4, 7, 14
Cardiac	Cardiac Pediatric	P	P	P		P	Note 1	Note 4, 7, 14
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

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

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan
Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 2: Includes imaging for guidance of biopsy

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EVN4-9 for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 9
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 9, 12, 13
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)	P	P	P		P	Note 1	Note 2, 7, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

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

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan

Note 13: Includes Urology/Prostate Note 14: Tissue Doppler Imaging (TDI)

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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, set against a blue oval background. The font is sans-serif and appears to be bolded.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: DP2B for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	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 (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 K180409; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

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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, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-8 for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 4, 7,8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 6, 7, 8, 9,10, 11
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)

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

510(k) Premarket Notification - Traditional

Image /page/9/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-5 for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	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 10)	P	P	P	P	P	Note 1	Notes 2, 6, 7, 8, 9, 10, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)

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

510(k) Premarket Notification - Traditional

Image /page/10/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The logo is simple and recognizable, and it is often used on Samsung products and in advertising.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LN5-12 for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 2, 5, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

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

510(k) Premarket Notification - Traditional

Image /page/11/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L5-12/50 for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 2, 5, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)

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

510(k) Premarket Notification - Traditional

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: ER4-9 for use with HS30

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 7, 9, 12, 13
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note 1	Notes 2, 7, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

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

5. 510(K) Summary: K182632

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

Date Prepared December 07, 2018 1.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
Primary Contact Person 3. Jee Young Ju Requlatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82.31.8017.9573 Email: jee.ju@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: HS30 Diagnostic Ultrasound System -
Common Name: System, Imaging, Pulsed Doppler, Ultrasonic -
- System, Imaging, Pulsed Echo, Ultrasonic
  - Transducer, Ultrasonic, Diagnostic
Classification : 21 CFR 892.1550 Ultrasonic pulsed doppler imaging system - 21 CFR 892.1560 Ultrasonic pulsed echo imaging system 21 CFR 892.1570 Diagnostic ultrasonic transducer
Product Code(s): IYN, IYO, ITX -
Predicate Device 6.
- HS40 Diagnostic Ultrasound System (K180409) -

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

1. Device Description
  The HS30 is a general purpose, mobile, software controlled, diagnostic ultrasound system, Its function is to acquire ultrasound data and to display the data as 2D mode. M mode. Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, Elastoscan Mode or as a combination of these modes. The HS30 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

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

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

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

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

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

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

9. Technological Comparison to Predicate Devices

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

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

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

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

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

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

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

10. Summary of Non-Clinical Test

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

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices - Application of riskmanagement to medical devices
Electrical Safety	The HS30 Ultrasound System with defibrillation-proof ECG electrodewas 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
Biocompatibility	ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a riskmanagement process.
ReprocessingMedical Devices	FDA Guidance: Reprocessing Medical Devices in Health CareSettings: Validation Methods and Labeling issued on March 17,2015, revised June 9, 2017.
Software/Firmware-driven Functionality	All migrated probes and software functionality were evaluated usingthe same test criteria as the predicate for all applicable imagingmodes to ensure that migration into a new system design did notcompromise image quality with respect to the intended use of eachfeature.Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices issued on May 11, 2005
Ultrasound Safety	Information for Manufacturers Seeking Marketing Clearance ofDiagnostic Ultrasound Systems and Transducers issued September9, 2008IEC60601-2-37:2007 + 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 Acoustic
Output Indices on Diagnostic Ultrasound Equipment, Revision 2

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

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

12. Conclusion

Since the predicate device and subject device have a similar intended use and key technological features, the non-clinical data support the safety of the device and demonstrate that the HS30 Diagnostic Ultrasound System should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. concludes that the performance of the subject device is as safe and effective, and is therefore substantially equivalent, to the predicate device that is currently marketed for the same intended use.

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.