ACUSON Freestyle Diagnostic Ultrasound System

K200644 · Siemens Medical Solutions USA, Inc. · IYN · Apr 10, 2020 · Radiology

Device Facts

• Record ID: K200644
• Device Name: ACUSON Freestyle Diagnostic Ultrasound System
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Apr 10, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

Device Story

Portable ultrasound imaging system; utilizes linear and curvilinear array transducers (wireless or cable-connected). Inputs: ultrasonic echoes/signals. Processing: beam-free synthetic aperture, Pixelformer image reconstruction, speckle filtering, and time/gain compensation. Outputs: B-mode, Color Doppler, and Amplitude Doppler images on 15-inch LED display. Used in healthcare settings by trained professionals for diagnostic imaging and anatomical measurements (distance, ellipse, area). Features include dual/split screen, digital video output, and DICOM networking. Benefits: provides diagnostic information adjunctively to other clinical data; portable design facilitates use in various clinical environments.

Clinical Evidence

Bench testing only. No clinical studies were required. Verification and validation performed per 21 CFR 820 and ISO 13485:2016. Compliance demonstrated with acoustic output (AIUM/NEMA UD-2, UD-3), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1).

Technological Characteristics

Portable ultrasound console (10.5 lbs) with 15-inch LED display. Transducers: L8-3, L13-5, C5-2, and new L17-5 (5.0-17.0 MHz). Connectivity: wireless, DICOM, mobile link app. Software: GreenHills Integrity RTOS. Biocompatibility: ISO 10993-1. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, IEC 62304.

Indications for Use

Indicated for diagnostic imaging or fluid flow analysis of the human body in abdominal, pediatric, small organ, peripheral vessel, and musculoskeletal (conventional and superficial) applications. Performed by trained healthcare professionals in healthcare settings.

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

• ACUSON Freestyle™ Ultrasound System (v4.0) (K162417)

Submission Summary (Full Text)

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April 10, 2020

Siemens Medical Solutions USA, Inc. % Shruti Arora Regulatory Affairs Specialist 685 East Middlefield Road MOUNTAIN VIEW CA 94043

#### Re: K200644

Trade/Device Name: ACUSON Freestyle™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, OIJ, ITX Dated: March 10, 2020 Received: March 11, 2020

Dear Shruti Arora:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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 (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 ([e-mail]) or phone [phone] 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

#### K200644

Device Name

ACUSON Freestyle Diagnostic Ultrasound System

Indications for Use (Describe)

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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510 (k) Number (if known):

Device Name:

#### ACUSON Freestyle™ Diagnostic Ultrasound System

Intended Use:

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

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)<br>(Note 2) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------|------------------------------|-----------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | P | P | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | | | | P | P | | | |
| Small Organ<br>(Note 1) | | P | | | | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | | | | P | P | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

Additional Comments:
Note 1

B-mode and PWD mode or Color Doppler and PW mode Note 2

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510 (k) Number (if known):

| Device Name: | L8-3 Linear Array Transducer | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------------------|--------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)<br>(Note 2) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | P | P | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | | | | P | P | | | |
| Small Organ<br>(Note 1) | | P | | | | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | | | | P | P | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | | | | P | P | | | |
| Musculo-skeletal<br>Superficial | | P | | | | P | P | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis etc.

Note 2 B-mode and PWD mode or Color Doppler and PW mode

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510 (k) Number (if known):

#### Device Name: L13-5 Linear Array Transducer Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Mode of Operation Combined Color Color Amplitude Other CWD Clinical Application A B M PWD Velocity (Specify) Doppler Doppler (Specify) lmaging (Note 2) Ophthalmic Fetal P P P Abdominal Intraoperative

| Intraoperative<br>Neurological | | | | | | |
|----------------------------------|---|--|---|---|--|--|
| Pediatric | P | | P | P | | |
| Small Organ<br>(Note 1) | P | | P | P | | |
| Neonatal Cephalic | | | | | | |
| Adult Cephalic | | | | | | |
| Cardiac | | | | | | |
| Trans-esophageal | | | | | | |
| Transrectal | | | | | | |
| Transvaginal | | | | | | |
| Transurethral | | | | | | |
| Intravascular | | | | | | |
| Peripheral vessel | P | | P | P | | |
| Laparoscopic | | | | | | |
| Musculo-skeletal<br>Conventional | P | | P | P | | |
| Musculo-skeletal<br>Superficial | P | | P | P | | |
| Other (specify) | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc. Note 1

Note 2 B-mode and PWD mode or Color Doppler and PW mode

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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510 (k) Number (if known):

| Device Name:<br>Intended Use: | | L17-5 Linear Array Transducer<br>Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---|----------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------------------|--------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)<br>(Note 2) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | N | | | | N | N | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | | | | N | N | | | | |
| Small Organ<br>(Note 1) | | N | | | | N | N | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | N | | | | N | N | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | | | | N | N | | | | |
| Musculo-skeletal<br>Superficial | | N | | | | N | N | | | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc.
B-mode and PWD mode or Color Doppler and PW mode Note 1

Note 2

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510 (k) Number (if known):

| Device Name:<br>Intended Use: | C5-2 Curvilinear Array Transducer<br>Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------------------|--------------------|--|
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)<br>(Note 2) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | | | | P | P | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | | | | P | P | | | | |
| Small Organ<br>(Note 1) | | P | | | | P | P | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | | | | P | P | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | | | | P | P | | | | |
| Musculo-skeletal<br>Superficial | | P | | | | P | P | | | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc.
B-mode and PWD mode or Color Doppler and PW mode Note 1

Note 2

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

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### 510(K) SUMMARY

This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92.

| Date: | March 10th, 2020 | | | | | | | | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|----------|------------------|---------------------------------------|-----------------------|------------------|----------------------------------|----------|--------|
| 1. Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 | | | | | | | | | |
| Contact Person: | Shruti Arora<br>Tel: [phone] | | | | | | | | | |
| 2. Device Name: | ACUSON Freestyle™ Diagnostic Ultrasound System | | | | | | | | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | | | | | | | | |
| Classification: | <table><tr><th>Regulatory Class:</th><td>II</td></tr><tr><th>Review Category:</th><td>Tier II</td></tr><tr><th>Classification Panel:</th><td>Radiology</td></tr></table> | Regulatory Class: | II | Review Category: | Tier II | Classification Panel: | Radiology | | | |
| Regulatory Class: | II | | | | | | | | | |
| Review Category: | Tier II | | | | | | | | | |
| Classification Panel: | Radiology | | | | | | | | | |
| | <table><tr><td>Ultrasonic Pulsed Doppler Imaging System</td><td>892.1550</td><td>90-IYN</td></tr><tr><td>Ultrasonic Pulsed Echo Imaging System</td><td>892.1560</td><td>90-IYO<br/>90-OIJ</td></tr><tr><td>Diagnostic Ultrasound Transducer</td><td>892.1570</td><td>90-ITX</td></tr></table> | Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO<br>90-OIJ | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | | | | | | | |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO<br>90-OIJ | | | | | | | | |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | | | | | | | | |
| Manufacturing Site: | Siemens Medical Solutions USA, Inc.<br>5168 Campus Drive<br>Plymouth Meeting, PA 19462, UNITED STATES | | | | | | | | | |

#### 3. Legally Marketed Predicate Devices

The ACUSON Freestyle Diagnostic Ultrasound System; v4.1 (VA41A) is a portable ultrasound imaging system with accessories and proprietary software. This subject device VA41A is a modification to the predicate device and is substantially equivalent to the company's legally marketed device, ACUSON Freestyle 4.0 (VA40A) previously cleared as represented below:

| Predicate Device | 510(k) Number | Clearance Date |
|-----------------------------------------------|---------------|----------------|
| ACUSON Freestyle™<br>Ultrasound System (v4.0) | K162417 | 09/28/2016 |

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#### 4. Device Description

The ACUSON Freestyle™ Diagnostic Ultrasound System is a portable ultrasound imaging system where the system operates with linear and curvilinear array transducers. These transducers may be used in a wireless mode or using a probe adaptor cable and is capable of the following modes (these modes below can be operated in combination or individually):

- । B-Mode
- -Color Doppler Mode
- -Amplitude Doppler Mode

The ACUSON Freestyle™ Diagnostic Ultrasound System includes a main unit console with user interface controls, a 15-inch video display, and system electronics. The main unit weighs approximately 10.5 pounds and is 13.2 inches high, 14.7 inches wide, and 5 inches deep. The system may be mounted on a small roll stand, monitor arm, or tabletop. An optional external receiving antenna can be mounted to the unit console, this provides better line of sight to the wireless transducers. The system provides an intuitive and easy-to operate user interface. It has a compact and portable design and offers DICOM archival and networking capability.

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial. The system also provides the ability to measure anatomical structures using distance, ellipse and area measurements. This information may be used adjunctively with other medical data obtained by a physician for clinical diagnostic purposes.

#### 5. Intended Use and Indications for Use Statement

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

#### 6. Comparison of Technological Characteristics with the Predicate Device

The modified ACUSON Freestyle Diagnostic Ultrasound System is substantially equivalent to the company's own previously cleared ACUSON Freestyle. VA40A (K162417) with regard to both intended use and technological characteristics. Both the modified ultrasound system under this review and the predicate ultrasound system function in the same manner as all diagnostic ultrasound systems and transducers.

The submission device differs from the predicated devices as following:

- . The modified ACUSON Freestyle Diagnostic Ultrasound System includes the addition of the L17-5 transducer. The L17-5 transducer is substantially equivalent to the L13-5 in its indications for use and fundamental scientific technology where L13-5 was cleared as a part of the ACUSON Freestyle VA40A (v4.0) under K162417 . L17-5 is a modified version of L13-5 with higher frequency capability to improve near field resolution.
- The modified ACUSON Freestyle Diagnostic Ultrasound System updated the indications for use statement (Intended use) to delete the following indications: Fetal, Cardiac, Neonatal Cephalic. Intraoperative neurological and rephrased to include

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Image /page/10/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

the operator qualification and device use setting (previously cleared on the predicate device under K162417).

- The modified ACUSON Freestyle Diagnostic Ultrasound System incorporates other device usability enhancements and improved imaging features: Dual screen capability (viewing two imaging areas side by side), Import/export system settings, inclusion of digital video output (to support use of the device in interventional suites without the need for video converters), product data security (prevent unauthorized access to system or patient data) and software updates to enhance the user workflow and security requirements..
The foundation of the ACUSON Freestyle (this submission) is the ACUSON Freestyle (K162417) which will be updated with the VA41A software version supporting all transducers (L8-3, C5-2, L13-5 and L17-5) and all device clinical application. The ACUSON Freestyle with software version VA41A is substantially equivalent to the predicate device with regard to both the intended use, indications for use and technological characteristics. The table below compares the technological characteristics between the submission device and the predicate devices.

| | | Predicate Device (K162417) | | Proposed/Submission Device | | |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------|
| Feature /<br>Characteristic | ACUSON<br>Freestyle VA40A<br>(v4.0) | ACUSON Freestyle<br>Elite VA40A (v4.0) | ACUSON Freestyle<br>VA41A (v4.1) | ACUSON<br>Freestyle Elite<br>VA41A (v4.1) | SE Comparative<br>Conclusion | |
| Device Classification<br>(Regulation, Device<br>Class, Product code<br>and panel) | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: 90, Radiology<br>Ultrasonic Pulsed Doppler<br>Imaging System; 21 CFR #<br>892.1550<br>Product Code: IYN<br><br>Ultrasonic Pulsed Echo Imaging<br>System; 21 CFR # 892.1560<br>Product Code: IYO<br><br>Ultrasonic Pulsed Echo Imaging<br>System; 21 CFR # 892.1560<br>Product Code: OIJ<br><br>Diagnostic Ultrasound<br>Transducer; 21 CFR # 892.1570<br>Product Code: ITX | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: 90, Radiology<br>Ultrasonic Pulsed Doppler<br>Imaging System; 21 CFR #<br>892.1550<br>Product Code: IYN<br><br>Ultrasonic Pulsed Echo Imaging<br>System; 21 CFR # 892.1560<br>Product Code: IYO<br><br>Ultrasonic Pulsed Echo Imaging<br>System; 21 CFR # 892.1560<br>Product Code: OIJ<br><br>Diagnostic Ultrasound<br>Transducer; 21 CFR # 892.1570<br>Product Code: ITX | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: 90, Radiology<br>Ultrasonic Pulsed Doppler<br>Imaging System; 21 CFR #<br>892.1550<br>Product Code: IYN<br><br>Ultrasonic Pulsed Echo Imaging<br>System; 21 CFR # 892.1560<br>Product Code: IYO<br><br>Ultrasonic Pulsed Echo Imaging<br>System; 21 CFR # 892.1560<br>Product Code: OIJ<br><br>Diagnostic Ultrasound<br>Transducer; 21 CFR # 892.1570<br>Product Code: ITX | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: 90, Radiology<br>Ultrasonic Pulsed Doppler<br>Imaging System; 21 CFR #<br>892.1550<br>Product Code: IYN<br><br>Ultrasonic Pulsed Echo Imaging<br>System; 21 CFR # 892.1560<br>Product Code: IYO<br><br>Ultrasonic Pulsed Echo Imaging<br>System; 21 CFR # 892.1560<br>Product Code: OIJ<br><br>Diagnostic Ultrasound<br>Transducer; 21 CFR # 892.1570<br>Product Code: ITX | IDENTICAL | |
| Indications for Use: | | | | | | |
| ■ Fetal | √ | √ | - | - | MODIFIED<br>(Indication deleted) | |
| ■ Abdominal | √ | √ | √ | √ | IDENTICAL | |
| ■ Pediatric | √ | √ | √ | √ | IDENTICAL | |
| ■ Small Organ¹ | √ | √ | √ | √ | IDENTICAL | |
| ■ Cardiac | √ | √ | - | - | MODIFIED<br>(Indication deleted) | |
| | | Predicate Device (K162417) | | Proposed/Submission Device | | |
| Feature /<br>Characteristic | ACUSON<br>Freestyle VA40A<br>(v4.0) | ACUSON Freestyle<br>Elite VA40A (v4.0) | ACUSON Freestyle<br>VA41A (v4.1) | ACUSON<br>Freestyle Elite<br>VA41A (v4.1) | SE Comparative<br>Conclusion | |
| ■<br>Intraoperative | √ | √ | - | - | MODIFIED<br>(Indication deleted) | |
| ■<br>Intraoperative<br>Neurological | √ | √ | - | - | MODIFIED<br>(Indication deleted) | |
| ■<br>Peripheral vessel | √ | √ | √ | √…