Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound imaging modes and hardware.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended for "diagnostic imaging or fluid flow analysis," indicating its purpose is to identify or characterize conditions, not to treat them.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system "is intended for diagnostic imaging or fluid flow analysis of the human body." Additionally, the "Device Description" repeatedly refers to it as the "ACUSON Freestyle™ Diagnostic Ultrasound System."

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a main unit console, video display, system electronics, transducers (wireless and wired), and an optional external receiving antenna. It also mentions the physical dimensions and weight of the main unit. This indicates it is a hardware-based medical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the ACUSON Freestyle Ultrasound System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states "diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting". This describes a device used on the patient's body for imaging, not a device used to test samples from the body (which is the definition of an IVD).
Device Description: The description details an ultrasound system with transducers, a console, and a display. This is consistent with an imaging device, not a device for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.

Therefore, the ACUSON Freestyle Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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).

Product codes

IYN, IYO, OIJ, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdomen, Pediatric, Small Organs (e.g., breast, testes, thyroid, penis), Peripheral Vessels, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Appropriately trained healthcare professional in a healthcare setting.

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 ACUSON Freestyle Diagnostic Ultrasound System is verified and validated according to the design control requirements of 21 CFR 820 and ISO 13485:2016 quality system standards. The subject device had been subjected to extensive safety and performance testing before release to ensure the device meets all its specifications. The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.

Software documentation for a Moderate Level of Concern software per FDA's guidance document "Guidance for the Content of Premarket Submission for Software contained in Medical Devices" issued on May 11, 2005 is included as part of this submission.

The device has been evaluated for acoustic output, cleaning, and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety and have been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:

AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
Refer to the table below for the Safety/EMC and Biocompatibility standards.

Since the ACUSON Freestyle Diagnostic Ultrasound System is a class II device and uses the same technology and operating principles as existing predicate device, ACUSON Freestyle Ultrasound System (K162417), therefore clinical studies were not required to support substantial equivalence.

Further the device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis which identifies potential hazards and is conducted according to ISO 14971:2007 standard. These potential hazards are controlled during development, verification and validation testing for each of the device modifications. The complete risk analysis is available in the device risk hazard analysis report included as part of this submission.

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

Not Found

Predicate Device(s)

K162417

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

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: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The Department of Health and Human Services seal is a circular emblem with a stylized caduceus in the center. The FDA acronym is in a blue square, and the words "U.S. Food & Drug Administration" are in blue text to the right of the square.

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

1

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 (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

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

3

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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) 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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)
(Note 2)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P				P	P
Intraoperative
Intraoperative
Neurological
Pediatric		P				P	P
Small Organ
(Note 1)		P				P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P				P	P
Laparoscopic
Musculo-skeletal
Conventional		P				P	P
Musculo-skeletal
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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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) 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

Neurological
Pediatric	P	P	P
Small Organ
(Note 1)	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P
Laparoscopic
Musculo-skeletal
Conventional	P	P	P
Musculo-skeletal
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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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) Number (if known):

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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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Image /page/8/Picture/0 description: The image shows the text 'K200644' in a simple, sans-serif font. The text is black and appears to be on a white background. The letters and numbers are evenly spaced and of uniform size, creating a clear and legible sequence.

Image /page/8/Picture/2 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 series of orange dots arranged in a circular pattern.

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.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043
Contact Person:	Shruti Arora
Tel: (425) 375-6890
2. Device Name:	ACUSON Freestyle™ Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class:IIReview Category:Tier IIClassification Panel:Radiology	Regulatory Class:	II	Review Category:	Tier II	Classification Panel:	Radiology
Regulatory Class:	II
Review Category:	Tier II
Classification Panel:	Radiology
	Ultrasonic Pulsed Doppler Imaging System892.155090-IYNUltrasonic Pulsed Echo Imaging System892.156090-IYO
90-OIJDiagnostic Ultrasound Transducer892.157090-ITX	Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN	Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
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
90-OIJ
Diagnostic Ultrasound Transducer	892.1570	90-ITX
Manufacturing Site:	Siemens Medical Solutions USA, Inc.
5168 Campus Drive
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™
Ultrasound System (v4.0)	K162417	09/28/2016

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Image /page/9/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

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 /
Characteristic	ACUSON
Freestyle VA40A
(v4.0)	ACUSON Freestyle
Elite VA40A (v4.0)	ACUSON Freestyle
VA41A (v4.1)	ACUSON
Freestyle Elite
VA41A (v4.1)	SE Comparative
Conclusion
Device Classification
(Regulation, Device
Class, Product code
and panel)	Regulatory Class: II
Review Category: Tier II
Classification Panel: 90, Radiology
Ultrasonic Pulsed Doppler
Imaging System; 21 CFR #
892.1550
Product Code: IYN

Ultrasonic Pulsed Echo Imaging
System; 21 CFR # 892.1560
Product Code: IYO

Ultrasonic Pulsed Echo Imaging
System; 21 CFR # 892.1560
Product Code: OIJ

Diagnostic Ultrasound
Transducer; 21 CFR # 892.1570
Product Code: ITX | Regulatory Class: II
Review Category: Tier II
Classification Panel: 90, Radiology
Ultrasonic Pulsed Doppler
Imaging System; 21 CFR #
892.1550
Product Code: IYN