Acuson Freestyle Ultrasound System

K162417 · Siemens Medi Cal Solutions, Inc. · IYN · Sep 28, 2016 · Radiology

Device Facts

• Record ID: K162417
• Device Name: Acuson Freestyle Ultrasound System
• Applicant: Siemens Medi Cal Solutions, Inc.
• Product Code: IYN · Radiology
• Decision Date: Sep 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ACUSON Freestyle™ Utrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal. Abdominal, Intraoperative Neurological, Pediatric, Small Organ. Neonatal Cephalic. Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

Device Story

The ACUSON Freestyle™ is a diagnostic ultrasound system utilizing linear and curvilinear array transducers. Transducers operate in either wired or wireless configurations. The system performs diagnostic imaging and fluid flow analysis, supporting B-mode, color Doppler, and amplitude Doppler modes. It is intended for use by clinicians for imaging various anatomical structures and fluid flow. The system integrates with the Siemens ARTIS system and features wireless network connectivity and an external antenna. Output is displayed for clinical diagnosis and measurement of anatomical structures. The device benefits patients by providing non-invasive diagnostic imaging and flow analysis across a wide range of clinical applications.

Clinical Evidence

No clinical data was required for substantial equivalence. The device relies on bench testing, including acoustic output, biocompatibility, cleaning/disinfection, and thermal/electrical/electromagnetic safety testing to demonstrate substantial equivalence.

Technological Characteristics

Ultrasound imaging system using linear/curvilinear array transducers. Supports wired/wireless connectivity (7.5-8.5 GHz RF transmitter). Complies with AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62366, IEC 62304, NEMA UD-2, NEMA UD-3, and ISO 10993-1. Features include Multi-Hertz imaging, trapezoidal imaging, and DICOM compatibility. Powered by Lithium Ion battery.

Indications for Use

Indicated for diagnostic imaging or fluid flow analysis of the human body, including fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ (breast, testes, thyroid, penis), neonatal cephalic, cardiac, peripheral vessel, and musculoskeletal (conventional and superficial) applications.

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

• Penrith Elettra Diagnostic Ultrasound System (K100598)
• ACUSON S2000 (K152369)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 28, 2016

SIEMENS MEDICAL SOLUTIONS, INC. % Mr. MARK JOB THIRD PARTY REVIEWER REGULATORY TECHNOLOGY SERVICES LLC 1394 25TH STREET, NW BUFFALO MN 55313

Re: K162417

Trade/Device Name: Acuson Freestyle Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 29, 2016 Received: August 30, 2016

Dear Mr. Job:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name

ACUSON FreestyleTM Ultrasound System

Indications for Use (Describe)

The ACUSON Freestyle™ Utrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal. Abdominal, Intraoperative Neurological, Pediatric, Small Organ. Neonatal Cephalic. Cardiac, 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)

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510(k) Number (if known):

ACUSON FreestyleTM Diagnostic Ultrasound System Device Name:

Diagnostic Imaging or fluid flow analysis of the human body as follows: Intended Use:

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------------------|-------------------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify:<br>(Note 2) | Other:<br>Harmonic<br>Imaging |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | P | P | | | |
| Abdominal | | P | | | | P | P | | | |
| Intraoperative (Note 1) | | P | | | | P | P | | | |
| Intraoperative Neurological | | P | | | | P | P | | | |
| Pediatric | | P | | | | P | P | | | |
| Small Organ (Note 3) | | P | | | | P | P | | | |
| Neonatal Cephalic | | P | | | | P | P | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | | | | P | P | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | | | | P | P | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | | | | P | P | | | |
| Musculo-skeletal Superficial | | P | | | | P | P | | | |
| Other | | | | | | | | | | |

N=new indication, P = Previously Cleared, Blank: Not Claimed

### Additional Comments:

Note 1: For example Cardiac Note 2: B Mode and PWD mode, or Cardiac Doppler and PW Mode Note 3: Breast, Testes, Thyroid, Penis

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510(k) Number (if known):

L8-3 Linear Transducer Device Name:

Intended Use:

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

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|----------------------------------|-------------------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify:<br>Note 2) | Other:<br>Harmonic<br>Imaging |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | P | P | | | |
| Abdominal | | P | | | | P | P | | | |
| Intraoperative (Note 1) | | P | | | | P | P | | | |
| Intraoperative Neurological | | P | | | | P | P | | | |
| Pediatric | | P | | | | P | P | | | |
| Small Organ (Note 3) | | P | | | | P | P | | | |
| Neonatal Cephalic | | P | | | | P | P | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | | | | P | P | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | | | | P | P | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | | | | P | P | | | |
| Musculo-skeletal Superficial | | P | | | | P | P | | | |
| Other | | | | | | | | | | |

N=new indication, P = Previously Cleared, Blank: Not Claimed

## Additional Comments: Note 1: For example Cardiac Note 2: B Mode and PWD mode, or color Doppler and PW Mode Note 3: Breast, Testes, Thyroid, Penis

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510(k) Number (if known):

Device Name:

L12-5 Linear Transducer

Intended Use:

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

| Clinical Application | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|-------|------------------------------|------------------------------|----------------------------------|----------------------------|--|
| | A | B | M | PWD | CWD | Color | Amplitude<br>Doppler Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify:<br>Note 2) | Other: Harmonic<br>Imaging | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | P | | | | P | P | | | | |
| Abdominal | | P | | | | P | P | | | | |
| Intraoperative (Note 1) | | P | | | | P | P | | | | |
| Intraoperative Neurological | | P | | | | P | P | | | | |
| Pediatric | | P | | | | P | P | | | | |
| Small Organ (Note 3) | | P | | | | P | P | | | | |
| Neonatal Cephalic | | P | | | | P | P | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | | | | P | P | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | P | | | | P | P | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | P | | | | P | P | | | | |
| Musculo-skeletal Superficial | | P | | | | P | P | | | | |
| Other | | | | | | | | | | | |

N=new indication, P = Previously Cleared, Blank: Not Claimed

### Additional Comments:

Note 1: For example Cardiac Note 2: B Mode and PWD mode, or color Doppler and PW Mode Note 3: Breast, Testes, Thyroid, Penis

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

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510(k) Number (if known):

Device Name:

C5-2 Curvilinear Transducer

Intended Use:

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

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|----------------------------------|-------------------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify:<br>Note 2) | Other:<br>Harmonic<br>Imaging |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | P | P | | | |
| Abdominal | | P | | | | P | P | | | |
| Intraoperative (Note 1) | | P | | | | P | P | | | |
| Intraoperative Neurological | | P | | | | P | P | | | |
| Pediatric | | P | | | | P | P | | | |
| Small Organ (Note 3) | | P | | | | P | P | | | |
| Neonatal Cephalic | | P | | | | P | P | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | | | | P | P | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | | | | P | P | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | | | | P | P | | | |
| Musculo-skeletal Superficial | | P | | | | P | P | | | |
| Other | | | | | | | | | | |

N=new indication, P = Previously Cleared, Blank: Not Claimed

### Additional Comments:

Note 1: For example Cardiac Note 2: B Mode and PWD mode, or color Doppler and PW Mode Note 3: Breast, Testes, Thyroid, Penis

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

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## 510(k) Summary

| Sponsor: | Siemens Medical Solutions, Inc.<br>Ultrasound Division<br>5168 Campus Drive<br>Plymouth Meeting, PA 19462 |
|----------|-----------------------------------------------------------------------------------------------------------|
|----------|-----------------------------------------------------------------------------------------------------------|

Contact Person: Primary Contact: Kevin Kong, RAC Telephone: [phone]

## Secondary Contact:

Lawrence Engle Telephone: [phone] Ext 102

- Submission Date: July 8, 2016
ACUSON Freestyle™ Ultrasound System Device Name:

- Common Name: Diagnostic Ultrasound System
- Classification: Regulatory Class: ll

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 ●

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Diagnostic Ultrasound Transducer

- 21 CFR # 892.1570 .
- . Product Code ITX

## Legally Marketed Predicate Devices

The ACUSON Freestyle™ Ultrasound System in this 510k is a modification to Penrith Elettra Diagnostic Ultrasound System (Primary predicate), previously cleared in K100598. The secondary predicate device is the ACUSON S2000 as cleared on K152369.

# Device Description:

The ACUSON Freestyle™ Ultrasound System is an ultrasound imaging system, which operates with linear, curvilinear, array transducers. The transducers may be used in either a wireless or wired configuration through a cable connected to the system.

# Intended Use

The ACUSON Freestyle™ Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

Image /page/8/Picture/11 description: The image shows the word "SIEMENS" in all capital letters. The text is a teal color. The font is sans-serif and appears to be bolded.

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## Substantial Equivalence

The submission device is a modification to Elettra Ultrasound System previously cleared in K100598 with regard use and technological characteristics and is also substantially equivalent to the ACUSON S2000 as cleared in K152369.

# Freestyle™ Ultrasound System Substantial Equivalence Table

| Description | ACUSON S2000<br>(Predicate K152369) | Penrith Elettra<br>(Predicate<br>K100598) | ACUSON<br>Freestyle™ (This<br>submission) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indications for Use<br>(Clinical Applications) | The ultrasound imaging systems are intended for the following applications: Fetal,<br>Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac,<br>Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial<br>Musculoskeletal, and Peripheral Vascular applications.<br><br>The system also provides the ability to measure anatomical structures {fetal,<br>abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic,<br>cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-<br>skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and<br>calculation packages that provide information to the clinician that may be used<br>adjunctively with other medical data obtained by a physician for clinical diagnosis<br>purposes.<br><br>The Arterial Health Package (AHP) software provides the physician with the<br>capability to measure Intima Media Thickness and the option to reference<br>normative tables that have been validated and published in peer-reviewed studies.<br>The information is intended to provide the physician with an easily understood tool<br>for communicating with patients regarding state of their cardiovascular system.<br>This feature should be utilized according to the "ASE Consensus Statement; Use<br>of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate<br>Cardiovascular Disease Risk: A Consensus Statement from the American<br>Association of Echocardiography; Carotid Intima-Media Thickness Task Force, | Diagnostic<br>Imaging or fluid<br>flow analysis of<br>the human body<br>as follows: Fetal,<br>Abdominal,<br>Intraoperative<br>Intraoperative<br>Neurological,<br>Pediatric, Small<br>Organ, Neonatal<br>Cephalic, Cardiac,<br>Peripheral Vessel,<br>Musculo-skeletal<br>(Conventional),<br>Musculo-skeletal<br>(Superficial) | Same as K100598 |

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| Description | ACUSON S2000<br>(Predicate K152369) | Penrith Elettra<br>(Predicate<br>K100598) | ACUSON<br>Freestyle™ (This<br>submission) |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| | Endorsed by the Society for Vascular Imaging. The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-<br>luminal visualization of cardiac and great vessel anatomy and physiology, as well<br>as visualization of other devices in the heart of adult and pediatric patients. | | |
| Product Code(s) | System: IYO, IYN<br>Transducer: ITX<br>Catheter: OBJ | -System: IYO, IYN<br>-Transducers: ITX | -System: IYO, IYN<br>-Transducers: ITX |
| Transducer Types | -Linear Array<br>-Phased Array<br>-Curved Array<br>-Pencil<br>-TEE | -Linear Array<br>-Curvilinear Array | -Linear Array<br>-Curvilinear Array |
| Description | ACUSON S2000<br>(Predicate K152369) | Penrith Elettra<br>(Predicate<br>K100598) | ACUSON<br>Freestyle™ (This<br>submission) |
| Modes of Operation | -B Mode | -B Mode | -B Mode |
| | -M Mode<br>-Pulsed Wave Doppler (PWD)<br>-Continuous Wave Doppler (CWD)<br>-Color Doppler<br>-Amplitude Doppler<br>-Combined (BMDC) | -Color Doppler<br>Mode<br>-Amplitude<br>Doppler Mode | -Color Doppler<br>Mode<br>-Amplitude<br>Doppler Mode |
| Functionality with<br>Siemens ARTIS<br>System | N/A | N/A | √ |
| Imaging | | | |
| Multi-Hertz multiple<br>frequency imaging | √ | √ | √ |
| Acoustic output<br>display standard<br>compliance | √ | √ | √ |
| Measurements<br>(Distance, Area,<br>Elliptical) | √ | √ | √ |
| Trapezoidal (Wide)<br>Imaging | √ | N/A | √ |
| Description | ACUSON S2000<br>(Predicate K152369) | Penrith Elettra<br>(Predicate<br>K100598) | ACUSON<br>Freestyle™ (This<br>submission) |
| Wireless<br>Transducer | | | |
| Wireless Ultrasound<br>Image Transmission | N/A | B, Color,<br>Amplitude | B, Color,<br>Amplitude |
| Meets FCC Part 15<br>Subpart B:<br>Unintentional<br>Radiators | N/A | Yes | Yes |
| Meets FCC Part 15<br>Subpart C: Intentional<br>Radiators | N/A | Yes | Yes |
| Meets FCC Part 15<br>Subpart F : Ultra<br>Wideband Operation | N/A | Yes | Yes |
| Meets FCC Part 95<br>(WMTS) | N/A | No | No |
| Frequency Range RF<br>Transmitter | N/A | 7.5-8.5 GHz | 7.5-8.5 GHz |
| Lithium Ion Battery<br>Operation | N/A | Yes | Yes |
| Connectivity | | | |
| Wireless Network<br>Connectivity | N/A | √ | √ |
| External Antenna | N/A | N/A | √ |
| DICOM Compatibility | √ | √ | √ |

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# SIEMENS

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# Non-clinical Tests submitted, referenced, or relied on for determination of substantial equivalence

The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfectiveness as well as thermal, electrical, electromagnetic and mechanical safety and to conform with applicable medical devices safety standards. The systems comply with the following standards:

- · AAMI/ANSI 60601-1: Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance
- · IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance: Electromagnetic Compatibility
- · IEC 60601-2-37: Medical Electrical Equipment Part 2-37 For Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic Monitoring Equipment
- IEC 62366: Medical Devices Application of Usability .
- IEC 62304: Medical Device Software Software Life Cycle Process .
- NEMA UD-2: Acoustic Output Measurement Standard for Diagnostic Ultrasound ●
- NEMA UD-3: Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- · ISO 10993-1: Biological Evaluation of Medical Devices

# Summary discussion of the clinical tests submitted, referenced, or relied on for determination of substantial equivalence

The ACUSON Freestyle™ Ultrasound System is a class II device, and uses the same technology and operating principle as the predicate devices; clinical data is not required for substantial equivalence.

# Conclusion

As shown by the substantial equivalence table above, the ACUSON Freestyle™ is substantially equivalent as the predicate devices; Penrith Elettra Ultrasound System (K100598) and the ACUSON S2000 (K152369).

# SIEMENS