HS70A Diagnostic Ultrasound System

K200699 · Samsung Medison Co., Ltd. · IYN · May 7, 2020 · Radiology

Device Facts

• Record ID: K200699
• Device Name: HS70A Diagnostic Ultrasound System
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: May 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel. The Diagnostic Ultrasound System is intended for use by, or by the order of, and under the supervision of, a licensed physician 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.

Device Story

HS70A is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays it in modes including 2D, M-mode, Color/Power Doppler, PW/CW Spectral Doppler, S-Harmonic, 3D/4D, and Elastoscan. The system provides measurement and analysis packages to assist clinicians in diagnosis. Used in hospitals, clinics, and private practices by physicians or under their supervision. The system displays real-time acoustic output (mechanical and thermal indices). It incorporates software features like IOTA-ADNEX, BiometryAssist, 5D Heart, and CrystalVue Flow to aid in anatomical measurement and clinical assessment. The device benefits patients by providing non-invasive diagnostic imaging and fluid analysis.

Clinical Evidence

No clinical data. Bench testing only. The device was evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, ISO 10993-1, IEC 60601-2-37, NEMA UD 2-2004). Software functionality was verified through bench testing.

Technological Characteristics

Mobile cart-based ultrasound system with 192 transmit/receive channels. Features 23-inch or 23.8-inch LED-backlit LCD monitor. Supports linear, curved linear, endocavity, phased array, and static probes (1.0–20.0 MHz). Connectivity includes WLAN, DICOM, and ECG input. Software-controlled with features like Q Scan, ClearVision, MultiVision, and various 3D/4D imaging/analysis tools. Biocompatibility per ISO 10993-1. Electrical safety per ANSI AAMI ES60601-1. EMC per IEC 60601-1-2.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis of the human body across clinical applications including fetal/obstetrics, abdominal, gynecology, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac (adult/pediatric/trans-esophageal), and peripheral vessels. Intended for use by or under the supervision of a licensed physician in clinical environments.

Regulatory Classification

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.

Predicate Devices

• HS70A Diagnostic Ultrasound System (K173713)
• HERA W9/HERA W10 Diagnostic Ultrasound System (K192319)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized depiction of the Department of Health & Human Services logo. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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

Re: K200699

Trade/Device Name: HS70A 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: March 13, 2020 Received: March 17, 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 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

May 7, 2020

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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 (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 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 ([e-mail]) or phone [phone] 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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### Indications for Use

510(k) Number (if known) K200699

Device Name HS70A Diagnostic Ultrasound System

### Indications for Use (Describe)

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

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

The Diagnostic Ultrasound System is intended for use by, or by the order of, and under the supervision of, a licensed physician 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.

| Type of Use (Select one or both, as applicable) | <table><tr><td><label><input checked="checked" type="checkbox"/> Remediation Use (Part 21 CFR 201.3 Labeling)</label></td></tr><tr><td><label><input type="checkbox"/> Over-The-Counter Use (OTC)</label></td></tr></table> | <label><input checked="checked" type="checkbox"/> Remediation Use (Part 21 CFR 201.3 Labeling)</label> | <label><input type="checkbox"/> Over-The-Counter Use (OTC)</label> |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| <label><input checked="checked" type="checkbox"/> Remediation Use (Part 21 CFR 201.3 Labeling)</label> | | | |
| <label><input type="checkbox"/> Over-The-Counter Use (OTC)</label> | | | |

| > Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Premarket Notification - Traditional

Image /page/3/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.

### 5. 510(K) Summarv: K200699

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

- Date Prepared March 13, 2020 1.
- 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, Republic of Korea

#### 3. Contact Person

Primary contact Ji Yea Lee Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail]

Secondary Contact Ninad Gujar Director of Regulatory & Quality Phone: [phone] Fax: [phone] Email: [e-mail]

#### 4. Proposed Device

- Common/Usual Name: Diagnostic Ultrasound System and Accessories
- Proprietary Name: HS70A Diagnostic Ultrasound System
- Regulation Name: Ultrasound pulsed Doppler imaging system
- Panel/ Requlatory Class: Radiology / II
- Product Code: IYN, IYO, ITX
- Regulation : 21 CFR 892.1550, 892.1560, 892.1570
- 5. Predicate Device: HS70A Diagnostic Ultrasound System (K173713) Second Predicate Device:

HERA W9/HERA W10 Diagnostic Ultrasound System (K192319)

#### Device Description 6.

The HS70A 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, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

#### 7. Indications for Use

The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound

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510(k) Premarket Notification - Traditional

Image /page/4/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the letters are evenly spaced. The oval is tilted slightly to the right.

imaging and fluid analysis of the human body.

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

The Diagnostic Ultrasound System is intended for use by, or by the order of, and under the supervision of, a licensed physician 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.

#### 8. Technology

The HS70A employs the same fundamental scientific technology as its predicate devices.

#### 9. Determination of Substantial Equivalence

The proposed HS70A is similar to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. A comparison of the proposed device to the currently marketed predicates is provided in the table below.

| HS70A | Addition of V2.02 | Remarks | | | | | | | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Clinical application | - No addition | | | | | | | | | | | |
| Operation of modes | - No addition | | | | | | | | | | | |
| Applied transducers | - EV2-10A | Transducer 510(k) Clearance EV2-10A K192319 | | | | | | | | | | |
| SW Features | - Addition of predicate S/W features:<br>: IOTA-ADNEX, BiometryAssist, 5D Heart, CrystalVue Flow<br>- Improvement of cleared S/W functions:<br>: Measurement, Setup&Preferences, Utility, DICOM, 5D Follicle, Sonoview | SW Features 510(k) clearance IOTA-ADNEX K192319 BiometryAssist K192319 5D Heart K192319 CrystalVue Flow K192319 | | | | | | | | | | |
| HW Features | - 23.8 inch Monitor | | | | | | | | | | | |

### <Change List>

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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, bold letters. The word is placed inside a blue, oval-shaped background.

<Comparison Table>

| | HS70A<br>(Under Review) | HS70A<br>(K173713) | HERA W9/HERA W10<br>(K192319) | Note |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Device name | The subject device | Primary Predicate | Second Predicate | |
| Manufacturer | SAMSUNG MEDISON. | SAMSUNG MEDISON. | SAMSUNG MEDISON. | |
| Regulation No. | 892.1550<br>892.1560<br>892.1570 | 892.1550<br>892.1560<br>892.1570 | 892.1550<br>892.1560<br>892.1570 | |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | Same to predicate |
| Intended Use | The Diagnostic Ultrasound<br>System and transducers are<br>intended for diagnostic<br>ultrasound imaging and fluid<br>analysis of the human body. | The Diagnostic Ultrasound<br>System and transducers are<br>intended for diagnostic<br>ultrasound imaging and fluid<br>analysis of the human body. | The Diagnostic Ultrasound<br>System and transducers are<br>intended for diagnostic<br>ultrasound imaging and fluid<br>analysis of the human body. | |
| clinical Application | - Fetal/Obstetrics | - Fetal/Obstetrics | Fetal/Obstetrics | Same to predicate |
| | - Abdominal | - Abdominal | Abdominal | Same to predicate |
| | - Gynecology | - Gynecology | Gynecology | Same to predicate |
| | - Intra-operative | - Intra-operative | | Same to predicate |
| | - Pediatric | - Pediatric | Pediatric | Same to predicate |
| | - Small Organ | - Small Organ | Small Organ | Same to predicate |
| | - Neonatal Cephalic | - Neonatal Cephalic | Neonatal Cephalic | Same to predicate |
| | - Adult Cephalic | - Adult Cephalic | Adult Cephalic | Same to predicate |
| | - Trans-rectal | - Trans-rectal | Trans-rectal | Same to predicate |
| | - Trans-vaginal | - Trans-vaginal | Trans-vaginal | Same to predicate |
| | - Trans-esophageal<br>(Cardiac) | - Trans-esophageal<br>(Cardiac) | | Same to predicate |
| | - Muscular-Skeletal<br>(Conventional, Superficial) | - Muscular-Skeletal<br>(Conventional, Superficial) | Muscular-Skeletal<br>(Conventional, Superficial) | Same to predicate |
| | - Urology | - Urology | Urology | Same to predicate |
| | - Cardiac Adult | - Cardiac Adult | Cardiac Adult | Same to predicate |
| | - Cardiac Pediatric | - Cardiac Pediatric | Cardiac Pediatric | Same to predicate |
| | - Peripheral vessel | - Peripheral vessel | Peripheral vessel | Same to predicate |
| Scanhead Types | - Linear Array | - Linear Array | Linear Array | Same to predicate |
| Device name | HS70A<br>(Under Review) | HS70A<br>(K173713) | HERA W9/HERA W10<br>(K192319) | Note |
| | The subject device | Primary Predicate | Second Predicate | |
| | - Curved Linear Array | - Curved Linear Array | Curved Linear Array | Same to predicate |
| | - Endocavity | - Endocavity | Endocavity | Same to predicate |
| | - Phased Array | - Phased Array | Phased Array | Same to predicate |
| | - Static Probes | - Static Probes | Static Probes | Same to predicate |
| Scanhead<br>Frequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | Same to predicate |
| Acoustic Output<br>Display & FDA<br>Limits | - Display Feature for Higher<br>Output-Track3<br>- MI Output Display<br>- TI Output Display | - Display Feature for Higher<br>Output-Track3<br>- MI Output Display<br>- TI Output Display | - Display Feature for Higher<br>Output-Track3<br>- MI Output Display<br>- TI Output Display | Same to predicate |
| Modes of Operation | - B-mode | - B-mode | B-mode | Same to predicate |
| | - M-mode | - M-mode | M-mode | Same to predicate |
| | - Pulsed wave (PW)<br>Doppler | - Pulsed wave (PW) Doppler | Pulsed wave (PW) Doppler | Same to predicate |
| | - Continuous wave (CW)<br>Doppler | - Continuous wave (CW)<br>Doppler | Continuous wave (CW)<br>Doppler | Same to predicate |
| | - Color Doppler | - Color Doppler | Color Doppler | Same to predicate |
| | - Power Amplitude Doppler | - Power Amplitude Doppler | Power Amplitude Doppler | Same to predicate |
| | - Pulse Inversion Harmonic<br>Imaging (S-Harmonic) | - Pulse Inversion Harmonic<br>Imaging (S-Harmonic) | Pulse Inversion Harmonic<br>Imaging (S-Harmonic) | Same to predicate |
| | - 3D imaging mode | - 3D imaging mode | 3D imaging mode | Same to predicate |
| | - ElastoScan Mode | - ElastoScan Mode | ElastoScan Mode | Same to predicate |
| | - Combined modes | - Combined modes | Combined modes | Same to predicate |
| #Transmit Channels | 192 | 192 | 192 | Same to predicate |
| #Receive Channels | 192 | 192 | 192 | Same to predicate |
| System | - Beamformer 192 | - Beamformer 192 | Beamformer 192 | Same to predicate |
| Characteristics | - Mobile cart | - Mobile cart | Mobile cart | Same to predicate |
| | - LCD Monitor (LED<br>Backlight unit): | - LCD Monitor (LED<br>Backlight unit): | LCD Monitor (LED<br>Backlight unit): | Same to predicate |
| Device name | HS70A<br>(Under Review)<br>The subject device | HS70A<br>(K173713)<br>Primary Predicate | HERA W9/HERA W10<br>(K192319)<br>Second Predicate | Note |
| | 23inch, 23.8inch | 23inch | 23inch | |
| | - 256 gray shades on<br>monitor | - 256 gray shades on<br>monitor | 256 gray shades on monitor | Same to predicate |
| | - 100-240VAC, 1100VA,<br>- 50/60Hz | - 100-240VAC, 1100VA,<br>- 50/60Hz | 100-240VAC, 1100VA,<br>50/60Hz | Same to predicate |
| Product Safety<br>Certification | - IEC 60601-1 | - IEC 60601-1 | IEC 60601-1 | Same to predicate |
| | - CSA C22.2 No.601.1 | - CSA C22.2 No.601.1 | CSA C22.2 No.601.1 | Same to predicate |
| | - IEC 60601-2-37 | - IEC 60601-2-37 | IEC 60601-2-37 | Same to predicate |
| EMC Compliance | - IEC 60601-1-2 | - IEC 60601-1-2 | IEC 60601-1-2 | Same to predicate |
| Acoustic Output<br>Display Standard | - Track 3 | - Track 3 | Track 3 | Same to predicate |
| Biocompatibility<br>Compliance | - ISO10993-1 | - ISO10993-1 | ISO10993-1 | Same to predicate |
| Software<br>Functionality | - Q Scan | - Q Scan | - Q Scan | Same to predicate |
| | - ClearVision | - ClearVision | - ClearVision | Same to predicate |
| | - MultiVision | - MultiVision | - MultiVision | Same to predicate |
| | - Panoramic | - Panoramic | - Panoramic | Same to predicate |
| | - Needle Mate+ | - Needle Mate | - Needle Mate+ | Same to predicate |
| | - Auto IMT+ | - Auto IMT+ | - Auto IMT+ | Same to predicate |
| | - Strain+ | - Strain+ | | Same to predicate |
| | - Stress Echo | - Stress Echo | | Same to predicate |
| | - E-Strain | - E-Strain | E-Strain | Same to predicate |
| | - S-Shearwave | - S-Shearwave | | Same to predicate |
| | - S-Detect for Breast | - S-Detect for Breast | S-Detect for Breast | Same to predicate |
| Device name | HS70A<br>(Under Review)<br>The subject device | HS70A<br>(K173713)<br>Primary Predicate | HERA W9/HERA W10<br>(K192319)<br>Second Predicate | Note |
| | - S-Detect for Thyroid | - S-Detect for Thyroid | - S-Detect for Thyroid | Same to predicate |
| | - ADVR | - ADVR | - ADVR | Same to predicate |
| | - 3D Imaging (Volume Data<br>Acquisition) | - 3D Imaging (Volume Data<br>Acquisition) | - 3D Imaging (Volume Data<br>Acquisition) | Same to predicate |
| | - 3D Imaging presentation<br>(3D Cine/4D Cine/5D Cine) | - 3D Imaging presentation<br>(3D Cine/4D Cine/5D Cine) | - 3D Imaging presentation<br>(3D Cine/4D Cine/5D Cine) | Same to predicate |
| | -3D Rendering (MPR) | -3D Rendering (MPR) | -3D Rendering (MPR) | Same to predicate |
| | -3D XI (MSV/Oblique View) | -3D XI (MSV/Oblique View) | -3D XI (MSV/Oblique View) | Same to predicate |
| | -3D MXI (Volume Slice,<br>Mirror View) | -3D MXI (Volume Slice,<br>Mirror View) | -3D MXI (Volume Slice,<br>Mirror View) | Same to predicate |
| | - XI Volume CT (Volume<br>CT) | - XI Volume CT (Volume<br>CT) | - XI Volume CT (Volume<br>CT) | Same to predicate |
| | -3D MagiCut | -3D MagiCut | -3D MagiCut | Same to predicate |
| | -Volume Calculation<br>(VOCAL, XI VOCAL) | -Volume Calculation<br>(VOCAL, XI VOCAL) | -Volume Calculation<br>(VOCAL, XI VOCAL) | Same to predicate |
| | - XI STIC | - XI STIC | - XI STIC | Same to predicate |
| | - HDVI | - HDVI | - HDVI | Same to predicate |
| | - RealisticVue | - RealisticVue | - RealisticVue | Same to predicate |
| | - CEUS+ | - CEUS+ | - CEUS+ | Same to predicate |
| | - 5D Follicle | - 5D Follicle | | Same to predicate |
| | - HDVI | - HDVI | | Same to predicate |
| | - 5D NT | - 5D NT | - 5D NT | Same to predicate |
| | - 5D LB | - 5D LB | - 5D LB | Same to predicate |
| | - 5D CNS | - 5D CNS | - 5D CNS | Same to predicate |
| | - Auto NT (Old Name: 2D<br>NT) | - Auto NT (Old Name: 2D<br>NT) | - Auto NT (Old Name: 2D<br>NT) | Same to predicate |
| | - ElastoScan | - ElastoScan | - ElastoScan+ | Same to predicate |
| | - E-Thyroid | - E-Thyroid | - E-Thyroid | Same to predicate |
| | - E-Breast | - E-Breast | - E-Breast | Same to predicate |
| Device name | HS70A<br>(Under Review)<br>The subject device | HS70A<br>(K173713)<br>Primary Predicate | HERA W9/HERA W10<br>(K192319)<br>Second Predicate | Note |
| | - ArterialAnalysis | - ArterialAnalysis | | Same to predicate |
| | - IOTA-ADNEX | | - IOTA-ADNEX | Same; refer to SE<br>analysis 1 |
| | - BiometryAssist | | - BiometryAssist | Same; refer to SE<br>analysis 2 |
| | - CrystalVueFlow | | - CrystalVueFlow | SE; refer to SE<br>analysis 3 |
| | - 5D Heart | | - 5D Heart | SE; refer to SE<br>analysis 4 |
| Transducer | - CA1-7A | - CA1-7A | - CA1-7A | Same to predicate |
| | - CA2-8A | - CA2-8A | | Same to predicate |
| | - CF4-9 | - CF4-9 | - CF4-9 | Same to predicate |
| | - E3-12A | - E3-12A | - E3-12A | Same to predicate |
| | - VR5-9 | - VR5-9 | | Same to predicate |
| | - CA2-9A | - CA2-9A | | Same to predicate |
| | - CA3-10A | - CA3-10A | - CA3-10A | Same to predicate |
| | - EA2-11B | - EA2-11B | - EA2-11B | Same to predicate |
| | - L3-12A | - L3-12A | - L3-12A | Same to predicate |
| | - LA3-16A | - LA3-16A | | Same to predicate |
| | - LA3-16AI | - LA3-16AI | | Same to predicate |
| | - LA2-9A | - LA2-9A | - LA2-9A | Same to predicate |
| | - LA4-18B | - LA4-18B | - LA4-18B | Same to predicate |
| | - LM4-15B | - LM4-15B | | Same to predicate |
| | - PE2-4 | - PE2-4 | | Same to predicate |
| | - PA3-8B | - PA3-8B | - PA3-8B | Same to predicate |
| | - P4-12B | - P4-12B | | Same to predicate |
| | - PA1-5A | - PA1-5A | | Same to predicate |
| | - MMPT3-7 | - MMPT3-7 | | Same to predicate |
| | - CV1-8A | - CV1-8A | - CV1-8A | Same to predicate |
| | - V5-9 | - V5-9 | | Same to predicate |
| Device name | HS70A<br>(Under Review)<br>The subject device | HS70A<br>(K173713)<br>Primary Predicate | HERA W9/HERA W10<br>(K192319)<br>Second Predicate | Note |
| | - LV3-14A | - LV3-14A | | Same to predicate |
| | - CW4.0 | - CW4.0 | | Same to predicate |
| | - CW6.0…