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K Number
K202556
Device Name
HS30 Diagnostic Ultrasound System
Manufacturer
Samsung Medison Co., LTD
Date Cleared
2020-10-30

(57 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. 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. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.
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.
More Information

K182632, K200339

Not Found

No
The document does not mention AI, ML, or related terms, nor does it describe any features or functionalities that are typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis beyond standard measurements).

No
The device is described as a "diagnostic ultrasound system" and its function is to "acquire ultrasound data and to display the data" and "offers analysis packages that provide information that is used to make a diagnosis." There is no mention of treating or monitoring a disease or condition.

Yes

The "Intended Use / Indications for Use" section explicitly states "The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids." and "It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients." The "Device Description" also refers to it as a "diagnostic ultrasound system" and states that its analysis packages "provide information that is used to make a diagnosis."

No

The device is described as a "diagnostic ultrasound system" and mentions acquiring "ultrasound data" and displaying it. This inherently involves hardware components (transducers, processing units) to generate and receive ultrasound waves, not just software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states that this device is a "diagnostic ultrasound system" that obtains "ultrasound images" and "analyze body fluids". While it mentions analyzing body fluids, the primary function and the detailed description of its modes of operation are focused on generating and analyzing ultrasound images of internal anatomical structures.
  • Intended Use: The intended use describes imaging various anatomical sites within the body, not analyzing samples taken from the body.
  • Modes of Operation: All listed modes (2D, Doppler, M mode, etc.) are standard ultrasound imaging techniques.
  • Device Description: The description reinforces its function as an ultrasound system for acquiring and displaying ultrasound data.

While the device mentions analyzing body fluids, this is likely in the context of using ultrasound to visualize and potentially measure fluid collections within the body (e.g., ascites, pleural effusions), rather than performing laboratory-style analysis of fluid samples.

Therefore, the core function and intended use of this device align with a diagnostic imaging system, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. 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.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

Product codes

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients.

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

Not Found

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

Not Found

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

The subject of this premarket submission, HS30 is not required clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s)

K182632, K200339

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 30, 2020

Samsung Medison Co., LTD % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA

Re: K202556

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: August 31, 2020 Received: September 3, 2020

Dear Ji Yea Lee:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K202556

Device Name HS30 Diagnostic Ultrasound System

Indications for Use (Describe)

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. 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.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

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)

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3

510(k) Premarket Notification - Traditional

5. 510(K) Summarv: K202556

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

  • Date Prepared August 31, 2020 1.
    1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
    1. Primary Contact Person Ji Yea Lee Requlatory Affairs Specialist Phone: +82.2.2.2194.1594 Fax: +82.31.8017.9573 Email: jiyea722.lee@samsungmedison.com
    1. Secondary Contact Person Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
  • Proposed Device 5.
    • Common/Usual Name: Diagnostic Ultrasound System and Accessories
    • Proprietary Name: HS30 Diagnostic Ultrasound System -
    • Common Name: Diagnostic Ultrasound System ।
    • Classification Names: system, imaqing, pulsed doppler, ultrasonic ।
    • । Product Code: IYN, IYO, ITX
    • -Regulation: 21 CFR 892.1550, 892.1560, 892.1570

6. Predicates

  • HS30 Diagnostic Ultrasound System (K182632) Primary -
  • HS40 Diagnostic Ultrasound System (K200339) -
    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.

    1. Intended Use
      The diagnostic ultrasound system and probes are designed to obtain ultrasound images

4

510(k) Premarket Notification – Traditional

and analyze body fluids.

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.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

    1. Technology
      The HS30 employs the same fundamental scientific technology as the predicates.
    1. Determination of Substantial Equivalence
      The HS30 is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

| Feature | HS30
(Under Review) | HS30
(K182632)
Primary | HS40
(K200339) |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | - 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 |
    | Scanhead
    Types: | - Linear Array
  • Curved Linear Array
  • Endocavity
  • Phased Array
  • Static Probes | - 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 | 1.0 ~ 20.0 MHz |
    | Feature | HS30
    (Under Review) | HS30
    (K182632)
    Primary | HS40
    (K200339) |
    | Acoustic
    Output Display
    & FDA Limits: | - Display Feature for
    Higher Output-Track3
  • MI Output Display
  • TI Output Display | - 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: | - 2D Mode
  • Color Doppler Mode
  • Power Doppler (PD)
    mode
  • M mode
  • Pulsed Wave (PW)
    Doppler mode
  • Continuous Wave
    (CW) Doppler mode
  • Tissue Doppler
    Imaging (TDI) mode
  • Tissue Doppler Wave
    (TDW) mode
  • ElastoScan Mode
  • Combined modes
  • Multi-Image mode
    (Dual, Quad)
  • 3D/4D mode | - 2D Mode
  • Color Doppler Mode
  • Power Doppler (PD)
    mode
  • M mode
  • Pulsed Wave (PW)
    Doppler mode
  • Continuous Wave
    (CW) Doppler mode
  • Tissue Doppler
    Imaging (TDI) mode
  • Tissue Doppler Wave
    (TDW) mode
  • ElastoScan Mode
  • Combined modes
  • Multi-Image mode
    (Dual, Quad) | - 2D Mode
  • Color Doppler Mode
  • Power Doppler (PD)
    mode
  • M mode
  • Pulsed Wave (PW)
    Doppler mode
  • Continuous Wave
    (CW) Doppler mode
  • Tissue Doppler
    Imaging (TDI) mode
  • Tissue Doppler Wave
    (TDW) mode
  • ElastoScan Mode
  • Combined modes
  • Multi-Image mode
    (Dual, Quad)
  • 3D/4D mode |
    | 510(k) Track | Track 3 | Track 3 | Track 3 |
    | System
    Characteristics: | - Mobile cart
  • LED Monitor
  • 256 gray shades on
    monitor
  • 100-120V, 60 Hz;
  • 200-240V, 50 Hz | - Mobile cart
  • LED Monitor
  • 256 gray shades on
    monitor
  • 100-120V, 60 Hz;
  • 200-240V, 50 Hz | - Mobile cart
  • LED Monitor
  • 256 gray shades on
    monitor
  • 100-120V, 60 Hz;
  • 200-240V, 50 Hz |
    | Product Safety
    Certification | - IEC 60601-1
  • IEC60601-2-37 | - IEC 60601-1
  • IEC60601-2-37 | - IEC 60601-1
  • IEC60601-2-37 |
    | EMC
    Compliance | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 |
    | Functionality | - DICOM
  • Quick Scan (QScan)
  • ClearVision
  • MultiVision
  • Auto IMT+
  • Elastoscan
  • Panoramic
  • Needle Mate+
  • Strain +
  • EzExam+
  • 3D Imaging
    (Freehand 3D)
  • 3D Rendering (MPR) | - DICOM
  • Quick Scan (QScan)
  • ClearVision
  • MultiVision
  • Auto IMT+
  • Elastoscan
  • Panoramic
  • Needle Mate+
  • Strain +
  • EzExam+
  • 3D Imaging
    (Freehand 3D)
  • 3D Rendering (MPR) | - DICOM
  • Quick Scan (QScan)
  • ClearVision
  • MultiVision
  • Auto IMT+
  • Elastoscan
  • Panoramic
  • Needle Mate+
  • Strain +
  • EzExam+
  • 3D Imaging
    (Freehand 3D)
  • 3D Rendering (MPR) |
    | Feature | HS30
    (Under Review) | HS30
    (K182632)
    Primary | HS40
    (K200339) |
    | | 3D MagiCut
    3D XI(MSV, Oblique
    View, XI VOCAL)
    XI STIC
    2D NT
    BiometryAssist
    LaborAssist | 3D MagiCut | 3D MagiCut
    3D XI (MSV, Oblique
    View, XI VOCAL)
    XI STIC
    2D NT
    BiometryAssist
    LaborAssist |
    | Transducers | [Linear array] | [Linear array] | [Linear array] |
    | | -LN5-12
    -L5-12/50 | -LN5-12
    -L5-12/50 | -LA3-16AD
    -LN5-12
    -L5-12/50
    -L4-7
    -LS6-15 |
    | | [Curved array]
    -CF4-9
    -C2-8
    -C2-5
    -CA2-6BM | [Curved array]
    -CF4-9
    -C2-8
    -C2-5 | [Curved array]
    CA2-8AD
    -CF4-9
    -C2-8
    -C2-5
    -CA2-6BM |
    | | [Endo Cavity]
    -EVN4-9
    -ER4-9 | [Endo Cavity]
    -EVN4-9
    -ER4-9 | [Endo Cavity]
    -EVN4-9
    -ER4-9 |
    | | [Phased array]
    -PN2-4
    -SP3-8 | [Phased array]
    PN2-4 | [Phased array]
    -PN2-4
    -SP3-8 |
    | | [3D]
    -VN4-8
    -EV2-10A | | [3D]
    -VN4-8
    -V5-9
    -EV2-10A |
    | | [CW]
    DP2B | [CW]
    DP2B | [CW]
    DP2B
    -DP8B |
    | Biopsy Guides | BP-KIT-024 | BP-KIT-024 | - BP-KIT-024
  • BP-KIT-029 |
    | | - BP-KIT-035 [BP-KIT-
    035-NG]
  • BP-KIT-040 [BP-KIT-
    040-NG]
  • BP-KIT-045 [BP-KIT-
    045-NG]
  • BP-KIT-047 [BP-KIT-
    047-NG]
  • BP-KIT-049 [BP-KIT-
    049-NG]
  • BP-KIT-061
  • BP-KIT-085
  • BP-KIT-086 | - BP-KIT-035 [BP-KIT-
    035-NG]
  • BP-KIT-040 [BP-KIT-
    040-NG]
  • BP-KIT-045 [BP-KIT-
    045-NG]
  • BP-KIT-047 [BP-KIT-
    047-NG]
  • BP-KIT-061 | - BP-KIT-054 [BP-KIT-
    054-NG]
  • BP-KIT-055 [BP-KIT-
    055-NG]
  • BP-KIT-049 [BP-KIT-
    049-NG]
  • BP-KIT-060
  • BP-KIT-061
  • BP-KIT-068 [BP-KIT-
    068-NG]
  • BP-KIT-043
  • BP-KIT-085
  • BP-KIT-086 |
    | Feature | HS30
    (Under Review) | HS30
    (K182632)
    Primary | HS40
    (K200339) |
    | optional
    devices | - Digital B/W Video
    Printer
  • Digital Color Video
    Printer
  • USB Printer
    DVD recorder (DVR) | - Digital B/W Video
    Printer
  • Digital Color Video
    Printer
  • USB Printer
    DVD recorder (DVR) | - Digital B/W Video
    Printer
  • Digital Color Video
    Printer
  • USB Printer
    DVD recorder (DVR) |
    | Accessories | - Foot Switch
  • ECG
    Gel Warmer | - Foot Switch
  • ECG
    Gel Warmer | - Foot Switch
  • ECG
    Gel Warmer |

5

SAMSUNG

510(k) Premarket Notification – Traditional

6

Image /page/6/Picture/1 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.

510(k) Premarket Notification – Traditional

7

Image /page/7/Picture/1 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is horizontally oriented and centered.

510(k) Premarket Notification - Traditional

11. 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 safety, and has been found to conform with applicable medical device safety standards. The HS30 and its applications comply with voluntary standards.

Reference No.Title
IEC 60601-1ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,
C1:2009/(R)2012 and A2:2010 /(R)2012
Medical Electrical Equipment - Part 1: General Requirements for
basic safety and essential performance.
IEC 60601-1-2IEC60601-1-2: 2014(4th Edition), Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - EMC
IEC 60601-2-37IEC60601-2-37:2007 + A1:2015, Particular requirements for the
safety of ultrasonic medical diagnostic and monitoring equipment
ISO10993-1ISO 10993-1, Biological evaluation of medical devices -- Part 1:
Evaluation and testing within a risk management process.
ISO14971ISO 14971:2007, Medical devices - Application of risk management
to medical devices
NEMA UD 2-
2004NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment Revision 3
    1. Summary of Clinical Tests
      The subject of this premarket submission, HS30 is not required clinical studies to support substantial equivalence.
    1. Conclusion
      Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the HS30 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

END of 510(K) Summary i