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K Number
K192319
Device Name
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
Manufacturer
Samsung Medison Co., Ltd.
Date Cleared
2019-12-10

(106 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ultrasound diagnostic 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.
Device Description
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA W9/HERA W10 also give 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 HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. As compared with predicate device(HERA W10, K182595), the subject device has added new three transducers(EV2-10A, EA2-11AV and EA2-11AR) and nine biopsy kits (BP-KIT-079, BP-KIT-080, BP-KIT-081, BP-KIT-082, BP-KIT-085, BP-KIT-086, BP-KIT-089 and BP-KIT-089 and BP-KIT-090) and the product name of HERA W9. There are no change and new software features from the predicate device. The HERA ultrasound system is supported by software and the software is not modified for the subject system.
More Information

K182595

Not Found

No
The document explicitly states "There are no change and new software features from the predicate device" and "the software is not modified for the subject system." There is no mention of AI or ML in the device description or features.

No.
The device is described as a "diagnostic ultrasound system" designed to "obtain ultrasound images and analyze body fluids" and to provide "information that is used to make a diagnosis." There is no mention of therapeutic capabilities or treatment.

Yes

Explanation: The "Device Description" explicitly states, "The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section mentions that the system is designed to "obtain ultrasound images and analyze body fluids," and the device offers "analysis packages that provide information that is used to make a diagnosis by competent health care professionals."

No

The device description explicitly states it is a "software controlled, diagnostic ultrasound system" and mentions the inclusion of probes and biopsy kits, indicating it is a hardware system with software control, not a software-only device.

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

Here's why:

  • Intended Use: The intended use clearly states the device is designed to "obtain ultrasound images and analyze body fluids." While it analyzes body fluids, the primary function described is obtaining ultrasound images for diagnostic purposes.
  • Device Description: The description focuses on the ultrasound imaging capabilities (B-mode, M-mode, Doppler modes, 3D/4D imaging, etc.) and the ability to measure anatomical structures and provide analysis packages for diagnosis.
  • Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) using ultrasound waves.
  • Focus on Imaging: The entire description revolves around the acquisition and display of ultrasound images and related measurements.

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, rather than performing laboratory-style analysis of fluid samples.

Therefore, this device falls under the category of a diagnostic imaging system, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The ultrasound diagnostic 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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.

The HERA W9/HERA W10 also give 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 HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

As compared with predicate device(HERA W10, K182595), the subject device has added new three transducers(EV2-10A, EA2-11AV and EA2-11AR) and nine biopsy kits (BP-KIT-079, BP-KIT-080, BP-KIT-081, BP-KIT-082, BP-KIT-085, BP-KIT-086, BP-KIT-089 and BP-KIT-089 and BP-KIT-090) and the product name of HERA W9. There are no change and new software features from the predicate device. The HERA ultrasound system is supported by software and the software is not modified for the subject system.

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

Competent health care professionals.

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 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 HERA W9/ HERA W10 and its applications comply with voluntary standards.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182595

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

December 10, 2019

Image /page/0/Picture/1 description: The image contains 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, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.

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

Re: K192319

Trade/Device Name: HERA W9 Diagnostic Ultrasound System, HERA W10 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: October 31, 2019 Received: November 4, 2019

Dear Ji Yea Lee:

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

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

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

1

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

For comprehensive regulatory information about medical devices and radiation-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,

For

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192319

Device Name HERA W9 Diagnostic Ultrasound System HERA W10 Diagnostic Ultrasound System

Indications for Use (Describe)

The ultrasound diagnostic 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.

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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of

information unless it displays a currently valid OMB number."

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6. 510(K) Summary

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

  • Date Prepared August 23, 2019 1.
    1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
    1. Primary Contact Person Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2194.1594 Fax: +82. 31.8017.9573 Email: jiyea722.lee@samsungmedison.com
    1. Proposed Device
    • Common/Usual Name: Diagnostic Ultrasound System and Accessories
    • Proprietary Name: HERA W9, HERA W10 Diagnostic Ultrasound System
    • Common Name: Diagnostic Ultrasound System
    • Classification Names: system, imaging, pulsed doppler, ultrasonic -
    • Product Code: IYN, IYO, ITX ၊
    • Regulation: 892.1550 i
    1. Predicate Device
    • HERA W10 Diagnostic Ultrasound System (K182595) ।
      • · Common/Usual Name: Diagnostic Ultrasound System and Accessories
      • · Proprietary Name: HERA W10 Diagnostic Ultrasound System
      • · Common Name: Diagnostic Ultrasound System
      • · Classification Names: system, imaging, pulsed doppler, ultrasonic
      • · Product Code: IYN, IYO, ITX
      • · Regulation number : 892.1550
      • · Class : Class II
    1. Device Description

The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.

The HERA W9/HERA W10 also give 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 HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

As compared with predicate device(HERA W10, K182595), the subject device has added new three transducers(EV2-10A, EA2-11AV and EA2-11AR) and nine biopsy kits (BP-KIT-079, BP-KIT-080, BP-KIT-081, BP-KIT-082, BP-KIT-085, BP-KIT-086, BP-KIT-089 and BP-KIT-089 and BP-KIT-090) and the product name of HERA W9. There are no change and new software features from the predicate device. The HERA ultrasound system is supported by software and the software is not modified for the subject system.

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DifferenceHERA W10HERA W9
SoftwareQuickPrep.SupportedNot Supported
HardwareInternal DVDIncludedNot Included
Caster size6"5"
Active array probe port4 port3 port (default), 4 port(option)
Main monitordefault: 21.5", option: 23", 23.8"default: 21.5", option: 23.8"

Also, the differences between HERA W10 and HERA W9 in the subject device are as below.

7. Intended Uses

The ultrasound diagnostic 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.

    1. Technology
      The HERA W9/ HERA W10 employ the same fundamental scientific technology as its predicate device.
    1. Determination of Substantial Equivalence
      The proposed HERA W9/ HERA W10 are substantially equivalent to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

As compared with predicate device(HERA W10, K182595), the subject device has added new three transducers(EV2-10A, EA2-11AV and EA2-11AR) and nine biopsy kits (BP-KIT-079, BP-KIT-080, BP-KIT-081, BP-KIT-082, BP-KIT-085, BP-KIT-086, BP-KIT-089 and BP-KIT-089 and BP-KIT-090) and the product name of HERA W9.

| Feature | HERA W9/ HERA W10
(Under Review) | HERA W10
(K182595) |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SAMSUNG MEDISON CO.,LTD | SAMSUNG MEDISON CO.,LTD |
| Intended Use | The HERA W9/ HERA W10
Diagnostic Ultrasound System and
transducers are intended for diagnostic
ultrasound imaging and fluid analysis
of the human body. | The HERA W10 Diagnostic
Ultrasound System and transducers are
intended for diagnostic ultrasound
imaging and fluid analysis of the
human body. |
| Clinical
Application | - Fetal/Obstetrics

  • Abdominal
  • Gynecology
  • Pediatric
  • Small Organ
  • Neonatal Cephalic
  • Adult Cephalic
  • Trans-rectal
  • Trans-vaginal
  • Muscular-Skeletal (Conventional, | - Fetal/Obstetrics
  • Abdominal
  • Gynecology
  • Pediatric
  • Small Organ
  • Neonatal Cephalic
  • Adult Cephalic
  • Trans-rectal
  • Trans-vaginal
  • Muscular-Skeletal (Conventional, |
    | Feature | HERA W9/ HERA W10
    (Under Review) | HERA W10
    (K182595) |
    | | Superficial)
  • Urology
  • Cardiac Adult
  • Cardiac Pediatric
  • Peripheral vessel | Superficial)
  • Urology
  • Cardiac Adult
  • Cardiac Pediatric
  • Peripheral vessel |
    | Scanhead Types | - Linear Array
  • Curved Linear Array
  • Endocavity
  • Phased Array | - Linear Array
  • Curved Linear Array
  • Endocavity
  • Phased Array |
    | Scanhead
    Frequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz |
    | 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 |
    | Modes of
    Operation | - B-mode
  • M-mode
  • Pulsed wave (PW) Doppler
  • Continuous wave (CW) Doppler
  • Color Doppler
  • Tissue Doppler Imaging (TDI)
  • Tissue Doppler Wave (TDW)
  • Power Amplitude Doppler
  • Pulse Inversion Harmonic Imaging
    (S-Harmonic)
  • Directional Power Doppler (S-Flow)
  • Color M-Mode
  • 3D Imaging Mode
  • 4D Imaging Mode
  • Elastoscan+TM Mode
  • MV-Flow Mode
  • Tissue Harmonic Imaging
  • Combination Modes | - B-mode
  • M-mode
  • Pulsed wave (PW) Doppler
  • Continuous wave (CW) Doppler
  • Color Doppler
  • Tissue Doppler Imaging (TDI)
  • Tissue Doppler Wave (TDW)
  • Power Amplitude Doppler
  • Pulse Inversion Harmonic Imaging
    (S-Harmonic)
  • Directional Power Doppler (S-Flow)
  • Color M-Mode
  • 3D Imaging Mode
  • 4D Imaging Mode
  • Elastoscan+TM Mode
  • MV-Flow Mode
  • Tissue Harmonic Imaging
  • Combination Modes |
    | #Transmit
    Channels | 192 | 192 |
    | #Receive
    Channels | 192 | 192 |
    | System
    Characteristics: | - Beamformer 192
  • Mobile cart
  • LCD Monitor (LED Backlight unit)
  • 256 gray shades on monitor
  • 100-240VAC, 1100VA, 50/60Hz | - Beamformer 192
  • Mobile cart
  • LCD Monitor (LED Backlight unit)
  • 256 gray shades on monitor
  • 100-240VAC, 1100VA, 50/60Hz |
    | Product Safety
    Certification | - IEC 60601-1
  • IEC 60601-1-2-37 | - IEC 60601-1
  • IEC 60601-1-2-37 |
    | Feature | HERA W9/ HERA W10
    (Under Review) | HERA W10
    (K182595) |
    | | - CSA C22.2 No.601.1 | - CSA C22.2 No.601.1 |
    | EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 |
    | Acoustic Output
    Display Standard | Track 3 | Track 3 |
    | Biocompatibility
    Compliance | ISO10993-1 | ISO10993-1 |
    | Functionality | - Q Scan | - Q Scan |
    | | - ClearVision | - ClearVision |
    | | - MultiVision | - MultiVision |
    | | - Panoramic | - Panoramic |
    | | - NeedleMate+ | - NeedleMate+ |
    | | - AutoIMT+ | - AutoIMT+ |
    | | - Elastoscan+ | - Elastoscan+ |
    | | - E-Thyroid | - E-Thyroid |
    | | - E-Breast | - E-Breast |
    | | - E-Strain | - E-Strain |
    | | - S-Detect for Breast | - S-Detect for Breast |
    | | - S-Detect for Thyroid | - S-Detect for Thyroid |
    | | - ADVR | - ADVR |
    | | - 3D Imaging | - 3D Imaging |
    | | - (Volume Data Acquisition) | - (Volume Data Acquisition) |
    | | - 3D Imaging presentation | - 3D Imaging presentation |
    | | - 3D Cine/4D Cine | - 3D Cine/4D Cine |
    | | - 3D Rendering MPR | - 3D Rendering MPR |
    | | - 3D XI MSV/Oblique View | - 3D XI MSV/Oblique View |
    | | - Volume CT | - Volume CT |
    | | - 3D MagiCut | - 3D MagiCut |
    | | - Volume Calculation | - Volume Calculation |
    | | - (VOCAL, XI VOCAL) | - (VOCAL, XI VOCAL) |
    | | - XI STIC | - XI STIC |
    | | - HDVI | - HDVI |
    | | - RealisticVue | - RealisticVue |
    | | - CEUS+ | - CEUS+ |
    | | - HQ-Vision | - HQ-Vision |
    | | - MV-Flow | - MV-Flow |
    | | - CrystalVue | - CrystalVue |
    | | - CrystalVue Flow | - CrystalVue Flow |
    | | - 5D CNS+ | - 5D CNS+ |
    | | - 5D Follicle | - 5D Follicle |
    | | - 5D Heart Color | - 5D Heart Color |
    | | - 5D Limb Vol | - 5D Limb Vol |
    | | - 5D LB | - 5D LB |
    | | - 5D NT | - 5D NT |
    | | - 2D NT | - 2D NT |
    | | - IOTA-ADNEX | - IOTA-ADNEX |
    | Feature | HERA W9/ HERA W10
    (Under Review) | HERA W10
    (K182595) |
    | | - BiometryAssit | - BiometryAssit |
    | | - E-Cervix | - E-Cervix |
    | | - LumiFlow | - LumiFlow |
    | | - ShadowHDR | - ShadowHDR |
    | | - MPI+ | - MPI+ |
    | Transducers | - L3-12A | - L3-12A |
    | | - LA2-9A | - LA2-9A |
    | | - LA4-18B | - LA4-18B |
    | | - CA1-7A | - CA1-7A |
    | | - CA2-9A | - CA2-9A |
    | | - CA3-10A | - CA3-10A |
    | | - CF4-9 | - CF4-9 |
    | | - E3-12A | - E3-12A |
    | | - EA2-11B | - EA2-11B |
    | | - VR5-9 | - VR5-9 |
    | | - PA4-12B | - PA4-12B |
    | | - PA3-8B | - PA3-8B |
    | | - PM1-6A | - PM1-6A |
    | | - CV1-8A | - CV1-8A |
    | | - EV3-10B | - EV3-10B |
    | | - EV2-10A
  • EA2-11AV
  • EA2-11AR | |
    | Biopsy Guides | - BP-KIT-029 | - BP-KIT-029 |
    | | - BP-KIT-041 | - BP-KIT-041 |
    | | - BP-KIT-043 | - BP-KIT-043 |
    | | - BP-KIT-054 | - BP-KIT-054 |
    | | - BP-KIT-057 | - BP-KIT-057 |
    | | - BP-KIT-058 | - BP-KIT-058 |
    | | - BP-KIT-059 | - BP-KIT-059 |
    | | - BP-KIT-060 | - BP-KIT-060 |
    | | - BP-KIT-065 | - BP-KIT-065 |
    | | - BP-KIT-066 | - BP-KIT-066 |
    | | - BP-KIT-067 | - BP-KIT-067 |
    | | - BP-KIT-069 | - BP-KIT-069 |
    | | - BP-KIT-071 | - BP-KIT-071 |
    | | - BP-KIT-076 | - BP-KIT-076 |
    | | - BP-KIT-077 | - BP-KIT-077 |
    | | - BP-KIT-078 | - BP-KIT-078 |
    | | - BP-KIT-079 | |
    | | - BP-KIT-080 | |
    | | - BP-KIT-081 | |
    | | - BP-KIT-082 | |
    | | - BP-KIT-085
  • BP-KIT-086
  • BP-KIT-088
  • BP-KIT-089
  • BP-KIT-090 | |
    | Feature | HERA W9/ HERA W10
    (Under Review) | HERA W10
    (K182595) |
    | Etc. | - Digital Storage/Transfer Station | - Digital Storage/Transfer Station |
    | Accessories | - Foot Switch
  • ECG
  • Gel Warmer
  • WLAN Adapter | - Foot Switch
  • ECG
  • Gel Warmer
  • WLAN Adapter |

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10. 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 HERA W9/ HERA W10 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

11. Summary of Clinical Tests

The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence.

12. 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 HERA W9/ HERA W 10 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

END of 510(K) Summary