SONIXTOUCH ULTRASOUND SYSTEM

• K Number: K083095
• Device Name: SONIXTOUCH ULTRASOUND SYSTEM
• Manufacturer: UltraSonix Medical Corporation
• Date Cleared: 2008-10-31 ( 14 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The SonixTouch Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial, Intravascular, Laparoscopic. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Device Description

The SonixTouch Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the SonixTouch Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle quides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle quides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

Predicate Devices

K080935, K061827, K053069, K062247, K060993, K080223, K072786, K061215

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The focus is on standard ultrasound imaging modes and features.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" and its intended uses are for "imaging" and "clinical diagnosis purposes," which are diagnostic rather than therapeutic applications.

Diagnostic

Yes
The "Device Description" states: "The SonixTouch Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system". The "Intended Use / Indications for Use" section also mentions the system provides "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system" and mentions hardware components such as probes, a console with controls, keyboard, touch panel, ECG display feature, and biopsy kits (accessories). While it is software-controlled, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SonixTouch Ultrasound Imaging System is an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use explicitly states that the system provides information to the clinician that "may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnosis.
• Device Description: The device is described as a "diagnostic ultrasound system." While ultrasound is an imaging modality, the purpose of the imaging is for diagnosis.
• Mentions image processing: The backend processing "yields an ultrasound image in realtime for diagnosis purposes." This further reinforces the diagnostic nature of the device.

While the device itself is an ultrasound scanner that produces images, the use of those images and the associated measurements and calculations for clinical diagnosis purposes places it within the scope of an IVD. The system is providing information derived from the patient (through ultrasound echoes) that is used to aid in diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonixTouch Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial, Intravascular, Laparoscopic.

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Product codes

IYN, IYO, ITX

Device Description

The SonixTouch Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the SonixTouch Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle quides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle quides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial, Intravascular, Laparoscopic.

Indicated Patient Age Range

Neonatal / Adult

Intended User / Care Setting

Not Found

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 submission includes a document "00.046.088_Ultrasonix_OP-SP_2.7.0_Release_Validation_Protocol_B_061308_ElastoValidation_Corina" included in the additional information dated October 14, 2008 which provides the verification protocol as well as expected results for elastography imaging. The report verifies the elasticity imaging algorithm (images actually in the validation protocol as well) can differentiate different structures with different rigidity.

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

Not Found

Predicate Device(s)

K080935, K061827, K053069, K062247, K060993, K080223, K072786, K061215

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

K0r3095

510 (k) Summary for the SonixTouch Ultrasound Scanner

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) summary.

1.0 Submitter Information

1.1 Submitter

Ultrasonix Medical Corporation 130-4311 Viking Way Richmond, British Columbia Canada V6V 2K9 (t) 604-279-8550 (f) 604-279-8559

OCT 3 1 2008

1.2 Contact

Chas Yu, Quality Assurance Manager (t) 604-279-8550 x 152 (f) 604-279-8559 (e) [e-mail]

1.3 Date Prepared

September 1, 2008

2.0 Device Name

2.1 Common Name

Ultrasound Imaging System

2.2 Proprietary Name

SonixTouch Ultrasound Scanner

2.3 Classification Name

	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

1

2.4 Classification

Class II

2.5 Predicate Device:

SONIX MDP Ultrasound Scanner (K080935) SONIX Ultrasound Scanner (K061827) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) Imacor Zura TEE System (K080223) Siemens S2000 Diagnostic Ultrasound System (K072786) Volcano S5i Family of Ultrasound Systems (K061215)

2.6 Reason for submission:

Name change request

N/A

New product clearance for:

SonixTouch Ultrasound Scanner and Transducers:

L14-5/38 C5-2/60 C5-2/40 EC9-5/10 SA4-2/24 SA3-1/24 L14-5W/60 PA7-4 BPSL9-5/55 BPC8-4/10 C7-3/50 4DC7-3/40 4DL14-5/38 4DEC9-5/10 L9-4/38 MC9-4/12 HST15-8/20 L15-8/26 TEM7-3/9 TEM10-7/5 TEEIMA LAP

2

2.7 Device description

The SonixTouch Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the SonixTouch Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle quides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle quides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

Frequency Range	2-15MHz
Transducer types	Linear array
	Curved array
	TEE array
	Intracavity array
	Phased array

3

The SonixTouch Ultrasound Scanner is designed to comply with the following standards and the system follows Track 3.

EN 60601-1	European Norm, Medical Electrical Equipment
UL 2601-1	Underwriters Laboratories Standards, Medical
Electrical Equipment
C22-2 No 601.1	Canadian Standards Association, Medical
Electrical Equipment
EM 60601-1-2	European Norm, Collateral Standard,
Electromagnetic Compatibility
IEC 60601-2-37	Particular requirements for the safety of
ultrasonic medical diagnostic equipment
AIUM	Acoustic Output Labeling Standard for Diagnostic
Ultrasound Equipment - Jan 1998
AIUM	Standard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices

3.0 Summary of Intended Uses

The SonixTouch Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial, Intravascular, Laparoscopic.

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

4.0 Comparison to Predicate Device

The SonixTouch Ultrasound Scanner is substantially equivalent to the predicate devices with respect to intended use/indications for use, principles of operation and technological characteristics.

The SONIX Touch Ultrasound Scanner includes a digital beamformer that is similar in function to the predicate devices beamformer. It allows transmitting and receiving signals through the ultrasound transducers. The ultrasound transducers are similar to the ones used on predicate devices.

The backend processing is also similar to the predicate devices and yields an ultrasound image in realtime for diagnosis purposes.

Elastography

The Elastography imaging mode is similar to the Siemens S2000 Elasticity imaging mode implementation (also called eSie Touch Elasticity Imaging).

4

The following slides explain the concept used for Elastography imaging:

Elastography is a method to extract the mechanical properties of tissue

Comparison of Ultrasound Imaging Techniques

Image /page/4/Picture/3 description: The image shows a medical ultrasound. The ultrasound displays a series of waveforms and grayscale images, likely representing blood flow or tissue density. The image also contains some text, but it is not legible. The ultrasound is likely being used for diagnostic purposes.

B-mode Observe internal structure types and boundaries

Doppler modes Observe internal flow and tissue motion

Elastography Observe mechanical properties of tissue

The imaging method involves applying a mechanical pressure with the hand on the transducer. The actual imaging sequence is similar to the B-mode sequence except that the system will acquire the RF signal instead of acquiring B mode data. The acoustic output transmission is identical to B-mode. The algorithm extracts a strain value information for every point on the image. The Elastography image then color-codes the stiff versus softer structures. The clinical benefits of elastography imaging are still under evaluation and no clinical diagnosis claim can be made other than being able to tell whether or not a structure inside the patient is stiffer than another one. The submission includes a document "00.046.088_Ultrasonix_OP-SP_2.7.0_Release_Validation_Protocol_B_061308_ElastoValidation_Corina" included in the additional information dated October 14, 2008 which provides the verification protocol as well as expected results for elastography imaging. The report verifies the elasticity imaging algorithm (images actually in the validation protocol as well) can differentiate different structures with different rigidity

5

Elastography Imaging Technique

Image /page/5/Picture/1 description: The image shows a dark screen with some text and graphical elements. The text "Soft" and "Hard" are visible on the left side of the screen, possibly indicating settings or options. There are some scattered bright spots and lines, which could be part of a user interface or some kind of data visualization. Due to the low resolution and contrast, it is difficult to discern the exact content or purpose of the screen.

stiff structure displaced but RF data unchanged color coded in Blue

softer structure displaced and RF data unchanged color coded in Red

Elastography verification data

The attached document "00.046.088_Ultrasonix_OP-

SP 2.7.0 Release Validation Protocol B 061308_ElastoValidation_Corina" includes verification protocol as well as expected results for elastography imaging. The report verifies that our elasticity imaging algorithm (images actually in the validation protocol as well) passes and can differentiate different structures with different rigidity.

5.0 Technological characteristics

The technological characteristics are substantially similar to that of the predicates. The device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D or M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler, Continuous Wave Doppler) are the same as the predicate devices identified in item 2.5. Transducer patient contact materials are biocompatible.

The beam forming architecture is very similar to that of the predicate devices. The receiving and processing hardware is similar but innovative in that it is a programmable system made of 2 building blocks, which can be reconfigured to operate the system in any imaging mode.

The parameters used to adjust image quality are the same as that seen in the predicates. This includes the use of TGC gain, depth control, base control and angling, among others.

6.0 Safety considerations

As track 3 ultrasound device, the SonixTouch Ultrasound Scanner is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by the National Electrical Manufacturers Association as UD-3.

6

With respect to limits on acoustic outputs, the SonixTouch Ultrasound Scanner complies with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the SonixTouch Ultrasound Scanner is designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601-2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.

The devices' acoustic output limits are:

ISPTA (d)	720mW/cm²
TIS/TIB/TIC	0.1 - 4.0 (Range)
Mechanical Index (MI)	1.9 (Maximum)
ISPPA (d)	0-700W/cm² (Range)

The limits are the same as predicate Track 3 devices.

7

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is a symbol of strength and freedom, and the logo represents the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 5 - 2009

Ultrasonix Medical Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K083095

Trade/Device Name: SonixTouch Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 16, 2008 Received: October 17, 2008

Dear Mr. Job:

This letter corrects our substantially equivalent letter of October 31, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the SonixTouch Ultrasound System, as described in your premarket notification:

Transducer Model Number

SA4-2/24 Phased Array 2.8 MHz 24 mm SA3-1/24 Phased Array 2.0 MHz 24mm PA7-4 Phased Array 5.0 MHz C5-2/60 Convex 3.2 MHz 60mm Radius C5-2/40 Convex 3.2 MHz 40mm Radius C7-3/50 Convex 5.0 MHz 50mm Radius EC9-5/10 Microconvex Endocavity 6.6 MHz 10mm Radius L14-5/38 Linear 8 MHz 38mm L9-4/38 Linear 6.5 MHz 38mm L14-5W/60 Linear 8 MHz 38mm

8

BPSL9-5/55/10L Linear ECBP 7.5 MHz BPSL9-5/55-10C Microconvex ECBP 6.5 MHz 4DC7-3/40mm 3D/4D Curved Transabdominal 3.5 MHz 4DEC9-5/10mm 3D/4D Endocavity 6.5 MHz MC9-4/12mm Mircoconvex 6.0 MHz 4DL14-5/38mm 3D/4D Linear 7.5 MHz HST15-8/20mm Hockey Stick Linear 10.0 MHz L15-8/26mm Linear 10.0 MHz TEM7-3/9mm Transesophageat 5.0 MHz TEM10-7/5mm Transesophageat 7.0 MHz TEEIMA Transesophageal 7.0 MHz LAP Laproscopic

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on vour responsibilities under the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Sunder Rajan at [phone].

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

9

Indications for Use

510(k) Number (if known): Device Name: SonixTouch Ultrasound Scanner Indications For Use:

The SonixTouch Ultrasound Scanner is intended for the following applications: Cardiac, Intraoperative (specific), Intraoperative Ophthalmic, Abdominal, Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Peripheral Vascular, Transvaginal, Transrectal, Transesophageal, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helsleuen

Page 1 of

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083095

10

ULTRASOUND INDICATIONS FOR USE TABLES

SonixTouch Ultrasound Scanner – Diagnostic Ultrasound Indications for Use Form

Intended use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	N	N	N	N		N	N	N	N (*1)	N (*2)
Fetal	N	N	N	N		N	N	N	N (*1)	N (*2)
Abdominal	N	N	N	N	N	N	N	N	N (*1)	N (*2)
Intraoperative (specify)	N	N	N	N		N	N	N	N (*1)	N (*2)
Intraoperative Neurological	N	N	N	N		N	N	N	N (*1)	N (*2)
Pediatric	N	N	N	N	N	N	N	N	N (*1)	N (*2)
Small Organ (specify)	N	N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic	N	N	N	N		N	N	N	N (*1)	N (*2)
Adult Cephalic	N	N	N	N		N	N	N	N (*1)	N (*2)
Cardiac	N	N	N	N	N	N	N	N	N (*1)	N (*2)
Transesophageal	N	N	N	N		N	N	N	N (*1)	N (*2)
Transrectal	N	N	N	N		N	N	N	N (*1)	N (*2)
Transvaginal	N	N	N	N		N	N	N	N (*1)	N (*2)
Transurethral
Transcranial	N	N	N	N		N	N	N	N (*1)	N (*2)
Peripheral Vascular	N	N	N	N		N	N	N	N (*1)	N (*2)
Laparoscopic	N	N	N	N		N	N	N	N (*1)	N (*2)
MSK Conventional	N	N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial	N	N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access	N	N	N	N		N	N	N	N (*1)	N (*2, *4)
Nerve Block	N	N	N	N		N	N	N	N (*1)	N (*2, *3)
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. BIM, BIPWD, BICWD, BICFMPWD, BIAD/PWD, BIOPD/PWD, BICFWCWD, B/AD/CWD, B/DPD/CWD
• 1. DiM, Dr VVD, Drover Dopler (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging.
• *3. Imaging for guldance of nerve block injections
• Imaging for guidance of central or peripheral lines. *4.

SONIX Touch User Manual

_

ﻨﺴ 1

Appendix C: Transdcuer Specifications

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

11

Diagnostic ULTRASOUND INDICATIONS FOR USE Form SA4-2/24 phased array 2.8 MHz 24mm transducer

Intended use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N	N	N (*1)	N (*2)
Small Organ (specify)
Neonatal Cephalic		N	N	N		N	N	N	N (*1)	N (*2)
Adult Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Cardiac		N	N	N	N	N	N	N	N (*1)	N (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial		N	N	N	N	N	N	N	N (*1)	N (*2)
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1 B/M B/PWD. B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

eraries : 1000: Minister : 12:00:40
11. Bik, BPWD, B/CFM/PWD, B/DPWD, B/DPDP, Pancamic Imaging, Hamonic Imaging, Hamonic Imaging, Hamonic Imaging, Harmonic Imaging, Harmo

Appendix C: Transdcuer Specifications

2

(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number	K083095

SONIX Touch User Manual

12

Diagnostic ULTRASOUND INDICATIONS FOR USE Form SA3-1/24 phased array 2.0 MHz 24mm transducer

Intended use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N	N	N (*1)	N (*2)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Adult Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Cardiac		N	N	N	N	N	N	N	N (*1)	N (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial		N	N	N	N	N	N	N	N (*1)	N (*2)
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/AD/CWD, B/DPD/CWD

• *2. Elastography, Directional Power (DPD), Imaging for guidance of biopsy, Panoramle Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.

SONIX Touch User Manual	Appendix C: Transdcuer Specifications
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices

510(k) Number K023045

13

Diagnostic ULTRASOUND INDICATIONS FOR USE Form PA7-4 phased array 5.0 MHz transducer

Intended use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N	N	N (*1)	N (*2)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Adult Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Cardiac		N	N	N	N	N	N	N	N (*1)	N (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial		N	N	N	N	N	N	N	N (*1)	N (*2)
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/OPD/CWD, B/OPD/CWD

"1. BM, BPWU, BIGHWFWD, BIGHMFWD, DIAL/ WD, Drom You Crem Porter Corporation Imaging, Hamonic Imaging, Hamonic Imaging, Hamonic Imaging, Namonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.

Appendix C: Transdcuer Specifications

4

(Division Sign-Off)
Division of Reproductive, Abdominal and

Brasion of Roproduct
510/k) Number 083 510(k) Number

SONIX Touch User Manual

14

Diagnostic ULTRASOUND INDICATIONS FOR USE Form C5-2/60 convex 3.2 MHz 60mm radius transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N (*1)	N (*2)
Abdominal		N	N	N		N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Trasncranial
Peripheral Vascular		N	N	N		N	N	N	N (*1)	N (*2)
Laparoscopic
MSK Conventional		N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*1. BM, B/PWD, B/CWD, B/DPWVD, B/DPD/PWD, B/CFMCWD, B/AD/CWD, B/OPD/CWD
*2. Elastography, Directional Power Dopels (DPD), Maging, Penoramic Imaging, Hamoric Imaging, Hamor

SONIX Touch User Manual		Appendix C: Transdcuer Specifications
-------------------------	--	---------------------------------------

5

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices,
510(k) Number	K083095

15

Diagnostic ULTRASOUND INDICATIONS FOR USE Form C5-2/40 convex 3.2 MHz 40mm radius transducer

Intended use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N (*1)	N (*2)
Abdominal		N	N	N		N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Trasncranial
Peripheral Vascular		N	N	N		N	N	N	N (*1)	N (*2)
Laparoscopic
MSK Conventional		N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

11. Elastography, Directional Power (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging,

Appendix C: Transdcuer Specifications
	6
	(Division Sign-Off)
	Division of Reproductive, Abdominal and
	SO

4083095

Radiological Devices

510(k) Number

SONIX Touch User Manual

16

Diagnostic ULTRASOUND INDICATIONS FOR USE Form Č7-3/50 convex 5.0 MHz 50mm radius transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N (*1)	N (*2)
Abdominal		N	N	N		N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Trasncranial
Peripheral Vascular		N	N	N		N	N	N	N (*1)	N (*2)
Laparoscopic
MSK Conventional		N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. BIM, BIPWD, BICWD, BICFM/PWD, BIAD/PWD, BIDPD/PWD, BICFM/CWD, BI/DPD/CWD

*2. Elastography, Directional Power Doppler (DPD), Imaging for guldance of biopsy, Panoramic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.

SONIX Touch User Manual

Appendix C: Transdcuer Specifications

从 (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

17

Diagnostic ULTRASOUND INDICATIONS FOR USE Form EC9-5/10 microconvex endocavity 6.6 MHz 10mm radius transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N	N	N (*1)	N (*2)
Transvaginal		N	N	N		N	N	N	N (*1)	N (*2)
Transurethral
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. BM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/DPD/CWD
• *2. Elastography, Directional Power (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.

Appendix C: Transdcuer Specifications

(Division Sign-Off)
---------------------

Division of Reproductive, Abdominal and
Radiological Devices

510(k) Number	4083095
---------------	---------

SONIXIX Touch User Manual

18

Diagnostic ULTRASOUND INDICATIONS FOR USE Form L14-5/38 linear 8 MHz 38mm transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N			N	N	N (*1)	N (*2)
Abdominal		N	N	N			N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N			N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N			N	N	N (*1)	N (*2)
Neonatal Cephalic		N	N	N			N	N	N (*1)	N (*2)
Adult Cephalic		N	N	N			N	N	N (*1)	N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Peripheral Vascular		N	N	N			N	N	N (*1)	N (*2)
Laparoscopic
MSK Conventional		N	N	N			N	N	N (*1)	N (*2)
MSK Superficial		N	N	N			N	N	N (*1)	N (*2)
Vascular Access		N	N	N			N	N	N (*1)	N (*2, *4)
Nerve Block		N	N	N			N	N	N (*1)	N (*2, *3)
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

SONIX

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• 11. BM, B/PWD, B/C/WD, B/O/PWD, B/DPPWD, B/DP/PWD, B/O/CWO, B/DPD/CWD
      *2. Elastography, Directional Power Dopels ( DPD), Maging for guitance of biopsy, Panoramic Imaging,
• *3. Imaging for guidance of nerve block injections
• *4. Imaging for guidance of central or peripheral lines.

Touch User Manual Appendix C: Transdcuer Specifications

	9
	(Division Sign-Off)

Division of Reproductive. Abdominal andDivision of Reproductive, Abdollian
510(k) Number ____________________________________________________________________________________________________________________________

19

Diagnostic ULTRASOUND INDICATIONS FOR USE Form L9-4/38 linear 6.5 MHz 38mm transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N (*1)	N (*2)
Abdominal		N	N	N		N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic		N	N	N		N	N	N	N (*1)	N (*2)
Adult Cephalic		N	N	N		N	N	N	N (*1)	N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Peripheral Vascular		N	N	N		N	N	N	N (*1)	N (*2)
Laparoscopic
MSK Conventional		N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access		N	N	N		N	N	N	N (*1)	N (*2, *4)
Nerve Block		N	N	N		N	N	N	N (*1)	N (*2, *3)
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
• 11. BM, BFWD, DVGYD, DVGT WT WO, Droin 105, Droi MSO, Dron Sor and Partic Partic Imaging, Harmonic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging,
  • *3. Imaging for guidance of nerve block injections
  • *4. Imaging for guidance of central or peripheral lines.

Appendix C: Transdcuer Specifications	SONIX Touch User Manual
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number	K083095

20

Diagnostic ULTRASOUND INDICATIONS FOR USE Form L14-5W/60 linear 8 MHz 38mm transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N	N	N	N	N	N (*1)	N (*2)
Abdominal		N	N	N	N	N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N	N	N	N	N	N (*1)	N (*2)
Neonatal Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Adult Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Peripheral Vascular		N	N	N	N	N	N	N	N (*1)	N (*2)
Laparoscopic
MSK Conventional		N	N	N	N	N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N	N	N	N	N	N (*1)	N (*2)
Vascular Access		N	N	N	N	N	N	N	N (*1)	N (*2, *4)
Nerve Block		N	N	N	N	N	N	N	N (*1)	N (*2, *3)
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DFD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
• • . Elastography, Directional Power Dopler (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging, TIssue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.
• *3. Imaging for guidance of nerve block injections
• *4. Imaging for guidance of central or peripheral lines.

SONIX Touch User Manual
-------------------------	--

	Appendix C: Transdcuer Specifications
11

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

21

Diagnostic ULTRASQUND INDICATIONS FOR USE Form BPSL9-5/55-10L linear ECBP 7.5 MHz transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N	N	N	N	N	N (*1)	N (*2)
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. B/M, B/PWD, B/CWD, B/CFMPWD, B/AG/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

Elastography, Directional Power Doppler (DPD), Imaging for guidance of biopsy, Panoramic Imaging, *2. Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.

Appendix C: Transdcuer Specifications

¹²

(Division Sign-Off) Division of Reproductive, Abdominal and Radiolog 510 (k) Number

SONIX Touch User Manual

22

Diagnostic ULTRASOUND INDICATIONS FOR USE Form BPSL9-5/55-10C microconvex ECBP 6.5 MHz transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N	N	N	N	N	N (*1)	N (*2)
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
• *2. Elastography, Directional Power Doppler (DPD), Imaging for guidence of biopsy, Panoramic Imaging,
  Tissue Dopler Imaging, Compound Imaging, Freehand 3D Imaging,

SONIX Touch User Manual	Appendix C: Transdcuer Specifications
-------------------------	---------------------------------------

13

(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number	K083095

23

Diagnostic ULTRASOUND INDICATIONS FOR USE Form 4DC7-3/40mm 3D/4D Curved Transabdominal 3.5 MHz transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N (*1)	N (*2)
Abdominal		N	N	N		N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular		N	N	N		N	N	N	N (*1)	N (*2)
Laparoscopic
MSK Conventional		N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DFD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

• *2. Elastography, Directional Power Doppler (DPD), Imaging for guidance of biopsy, Panoramic Imaging,
  Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging.

Appendix C: Transdcuer Specifications	SONIX Touch User Manual
	14
	(Division Sign-Off)
	Division of Reproductive, Abdominal and
	Radiological Devices
510(k) Number	5083095

24

Diagnostic ULTRASOUND INDICATIONS FOR USE Form 4DEC9-5/10mm 3D/4D Endocavity 6.5 MHz transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N	N	N	N	N	N (*1)	N (*2)
Transvaginal		N	N	N	N	N	N	N	N (*1)	N (*2)
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyrold, Testicle

Intraoperative: Abdominal organs and vascular

*1. BIM, BIPWD, B/CWD, B/CFMPWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/OPD/CWD

1. Elastography, Directional Power Dopler (DPD), Maging for guidence of biopsy, Pancamic Imaging, Hamonic Imaging, Hamonic Imaging, Tissue Doppier Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging,

SONIX Touch User Manual

Appendix C: Transdcuer Specifications

15

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

25

Diagnostic ULTRASOUND INDICATIONS FOR USE Form MC9-4/12mm microconvex 6.0 MHz transducer

Intended use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N	N	N (*1)	N (*2)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Adult Cephalic		N	N	N	N	N	N	N	N (*1)	N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial		N	N	N	N	N	N	N	N (*1)	N (*2)
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access		N	N	N		N	N	N	N (*1)	N (*2, *4)
Nerve Block		N	N	N		N	N	N	N (*1)	N (*2, *3)
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Appendix C: Transdcuer S

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/A/D/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
• 12 Birliy Dr A = D = D = = D = = D = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
• Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.
• *3. Imaging for guidance of nerve block injections
• *4. Imaging for guidance of central or peripheral lines.

Specifications		SON
	16

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SONIX Touch User Manual

26

Diagnostic ULTRASOUND INDICATIONS FOR USE Form 4DL14-5/38mm 3D/4D Linear 7.5 MHz transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N (*1)	N (*2)
Abdominal		N	N	N		N	N	N	N (*1)	N (*2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic		N	N	N		N	N	N	N (*1)	N (*2)
Adult Cephalic		N	N	N		N	N	N	N (*1)	N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic		N	N	N		N	N	N	N (*1)	N (*2)
MSK Conventional		N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access		N	N	N		N	N	N	N (*1)	N (*2, *4)
Nerve Block		N	N	N		N	N	N	N (*1)	N (*2, *3)
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. BIM, BIPWO, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
• *2. Elastography, Directional Power Doppler (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging,
• Tissue Dopplar Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging,
• *3. Imaging for guidance of nerve block injections
• *4. Imaging for guidance of central or peripheral lines.

SONIX Touch User Manual

Appendix C: Transdcuer Specifications

17

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27

Diagnostic ULTRASOUND INDICATIONS FOR USE Form HST15-8/20mm hockey stick linear 10.0 MHz transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic		N	N	N		N	N	N	N (*1)	N (*2)
Fetal		N	N	N		N	N	N	N (*1)	N (*2)
Abdominal
Intraoperative (specify)
Intraoperative Neurological		N	N	N		N	N	N	N (*1)	N (*2)
Pediatric		N	N	N		N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic		N	N	N		N	N	N	N (*1)	N (*2)
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial		N	N	N		N	N	N	N (*1)	N (*2)
Peripheral Vascular		N	N	N		N	N	N	N (*1)	N (*2)
Laparoscopic		N	N	N		N	N	N	N (*1)	N (*2)
MSK Conventional		N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access		N	N	N		N	N	N	N (*1)	N (*2, *4)
Nerve Block		N	N	N		N	N	N	N (*1)	N (*2, *3)
Other (specify)		N	N	N		N	N	N	N (*1)	N (*2)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

• *1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/DPD/CWD
• *2. Elastography, Directlonal Power (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging,
• Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.
• *3. Imaging for guidance of nerve block injections *4. Imaging for guidance of central or peripheral lines.

Appendix C: Transdcuer Specifications

SONIX Touch User Manual

18

(Division Sign-Off) Division of Reproductive, Abdominal and Radiologic 510(k) Number

28

Diagnostic ULTRASOUND INDICATIONS FOR USE Form L15-8/26mm linear 10.0 MHz transducer

Intended use:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic		N	N	N		N	N	N	N (*1)	N (*2)
Fetal		N	N	N		N	N	N	N (*1)	N (*2)
Abdominal
Intraoperative (specify)
Intraoperative Neurological		N	N	N		N	N	N	N (*1)	N (*2)
Pediatric		N	N	N		N	N	N	N (*1)	N (*2)
Small Organ (specify)		N	N	N		N	N	N	N (*1)	N (*2)
Neonatal Cephalic		N	N	N		N	N	N	N (*1)	N (*2)
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial		N	N	N		N	N	N	N (*1)	N (*2)
Peripheral Vascular		N	N	N		N	N	N	N (*1)	N (*2)
Laparoscopic		N	N	N		N	N	N	N (*1)	N (*2)
MSK Conventional		N	N	N		N	N	N	N (*1)	N (*2)
MSK Superficial		N	N	N		N	N	N	N (*1)	N (*2)
Vascular Access		N	N	N		N	N	N	N (*1)	N (*2, *4)
Nerve Block		N	N	N		N	N	N	N (*1)	N (*2, *3)
Other (specify)		N	N	N		N	N	N	N (*1)	N (*2)

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

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

• Elastography, Directional Power Doppler (DPD), Imaging for guidance of biopsy, Panoramic Imaging, *2. Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.
• *3. Imaging for guidance of nerve block injections
• *4. Imaging for guidance of central or peripheral lines.

SONIX Touch User Manual	Appendix C: Transdcuer Specifications
	19
	(Division Sign-Off)
	Division of Reproductive, Abdominal and

Radiological Device 510(k) Number

29

Diagnostic ULTRASOUND INDICATIONS FOR USE Form TEM7-3/9mm transesophageal 5.0 MHz transducer

Intended use:

Diagnostic ultrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		N	N	N	N	N	N	N	N (*1)	N (*2)
Transrectal
Transvaginal
Transurethrai
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

" ( " Bron", Drectional Power Dopler (DPD), Imaging for guidance of blopsy, Panoramic Imaging, Harmonic Imaging, M Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.

Appendix C: Transdcuer Specifications	SONIX Touch User Manual
---------------------------------------	-------------------------

20

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number	K083095

30

Diagnostic ULTRASOUND INDICATIONS FOR USE Form TEM10-7/5mm transesophageal 7.0 MHz transducer

Intended use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		N	N	N	N	N	N	N	N (*1)	N (*2)
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

12. Blance, Directional Power (DPD), Maging for guidance of biopsy, Panoranic Imaging, Hamonic Imaging, Tissue Doppier Imaging, Compound Imaging, Freehand 3D Imaging.

SONIX Touch User Manual Appendix C: Transdcuer Specifications

	21
(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices

510(k) Number	K083095
---------------	---------

31

Diagnostic ULTRASOUND INDICATIONS FOR USE Form TEEIMA transesophageal 7.0 MHz transducer

Intended use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		N	N	N	N	N	N	N	N (*1)	N (*2)
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. BIM, BIPWD, BICWD, BICFMIPWD, BIAD/PWD, BIOPD/PWD, B/CFM/CWD, B/DPD/CWD

*2. Elastography, Directional Power (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging.

Appendix C: Transdcuer Specifications
	22
	(Division Sign-Off)
	Division of Reproductive, Abdominal and
	Radiological Devices
510(k) Number	K083095

SONIX Touch User Manual

32

Diagnostic ULTRASOUND INDICATIONS FOR USE Form LAP Laparoscopic transducer

Intended use:

Diagnostic uitrasound 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
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic		N	N	N	N	N	N	N	N (*1)	N (*2)
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other (specify)

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

*1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/OPD/CWD

*2. Elast (1) Directionel Power Doptier (DPD), Imaging for guidance of blopsy, Panoramic Imaging, Hamonic Imaging,
Tissue Dopler Imaging, Compound Imaging, Freehand 3D Ima

SONIX Touch User Manual Appendix C: Transdcuer Specifications

23

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices

510(k) Number	K083095
---------------	---------