SONIX ULTRASOUND SCANNER

• K Number: K112726
• Device Name: SONIX ULTRASOUND SCANNER
• Manufacturer: UltraSonix Medical Corporation
• Date Cleared: 2011-09-27 ( 7 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The Sonix Ultrasound Scanner 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, 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 Sonix 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 Sonix 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 guides will support various sized needle guides are sold in sterile kits that contain multiple needle quides, sterile sheaths, ultrasound transmission gel, and bands.

Predicate Devices

K093462

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 or intended use. The processing described is standard ultrasound image processing.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" and its intended use is to provide "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." It is used to acquire and display ultrasound echo data for diagnosis, not for treating a condition.

Diagnostic

Yes

The device description explicitly states, "The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system." Additionally, the intended use and various sections consistently mention its use for "clinical diagnosis purposes" and displaying images "for diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as probes, a console with a keyboard and touch panel, an ECG display feature with a cable assembly, and biopsy kits made of polymeric brackets and needle guides. It is a complete ultrasound system, not just software.

IVD (In Vitro Diagnostic)

Based on the provided text, the Sonix Ultrasound Scanner is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• Sonix Ultrasound Scanner Function: The description clearly states that the Sonix Ultrasound Scanner is a diagnostic ultrasound system that acquires and displays ultrasound echo data. This is an in vivo imaging technique, meaning it examines the body directly without taking specimens.
• Intended Use: The intended uses listed are all related to imaging various anatomical sites within the body.
• Device Description: The description focuses on the hardware and software for generating and displaying ultrasound images, not on analyzing biological samples.

Therefore, the Sonix Ultrasound Scanner falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sonix 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,

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 (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

Device Description

The Sonix 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 Sonix 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 guides will support various sized needle guides are sold in sterile kits that contain multiple needle quides, 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, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal Cephalic, Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial

Indicated Patient Age Range

Neonatal / Adult

Intended User / Care Setting

Clinician

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)

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093462

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

510 (k) Summary for the Sonix Ultrasound Scanner

K112726

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

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

August 26, 2011

2.0 Device Name

2.1 Common Name

Ultrasound Imaging System

2.2 Proprietary Name

Sonix 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 Ultrasound Scanner (K093462) Predicate transducer for m4DC7-3/40: 4DC7-3/40 cleared under K093462 Predicate transducer for L40-8/12: L14-5/38 and HST15-8/20, both are cleared under K093462

2.6 Reason for submission:

Clearance request for:

Addition of the following two transducers to Sonix Ultrasound Scanner which was previously cleared under K093462.

• m4DC7-3/40 .
• . L40-8/12

Note:

Indications for use and modes of operation of the Sonix Ultrasound Scanner previously cleared under K093462 are unchanged.

Name change request

N/A

New product clearance for:

N/A

2

2.7 Device description

The Sonix 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 Sonix 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 guides will support various sized needle guides are sold in sterile kits that contain multiple needle quides, 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 Sonix 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
EN 60601-1-2	European Norm, Collateral Standard,
Electromagnetic Compatibility
IEC 60601-2-37	Particular requirements for the safety of
ultrasonic medical diagnostic equipment
AIUM AOL	Acoustic Output Labeling Standard for Diagnostic
Ultrasound Equipment
AIUM RTD	Standard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices

3.0 Summary of Intended Uses

The Sonix 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,

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

The Sonix 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.

Sonix Ultrasound Scanner (K093462)

Predicate transducer for m4DC7-3/40: 4DC7-3/40 cleared under K093462 Predicate transducer for L40-8/12: L14-5/38 and HST15-8/20, both are cleared under K093462

4

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 Sonix Ultrasound Scanner is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (2004)" published by the National Electrical Manufacturers Association as UD-3.

With respect to limits on acoustic outputs, the Sonix Ultrasound Scanner complies with the quideline limits set in the September 9, 2008 revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the Sonix 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	0.1-6.0 (Range)
Mechanical Index (MI)	1.9 (Maximum)
ISPPA (d)	0 - 700W/cm² (Range)

The limits are the same as predicate Track 3 devices.

5

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES, U.S.A." arranged around the circumference. Inside the circle is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is depicted in a simple, abstract manner with flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

SEP 2 7 2011

Re: K112726

Trade/Device Name: Sonix Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Requlatory Class: II Product Code: 1YN, IYO, and ITX Dated: September 19, 2011 Received: September 20, 2011

Dear Mr. Job:

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 Sonix Ultrasound Scanner, as described in your premarket notification:

Transducer Model Number

SA4-2/24 Phased Array SA3-1/24 Phased Array PA4-2/20 Phased Array PA7-4 Phased Arrav C5-2/60 and C5-2/60 GPS Convex C5-2/40 Convex

6

Image /page/6/Figure/1 description: The image shows a list of different types of ultrasound transducers. The list includes C7-3/50 Convex, MC9-4/12 Microconvex, EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity, L9-4/38 Linear, L14-5/38 and L14-5/38 GPS Linear, L14-5W/60 Wide Linear, L15-8/26 Linear, BPL9-5/55 Linear Endocavity Biplane, BPC8-4/10 Microconvex Endocavity Biplane, HST15-8/20 Linear, 4DC7-3/40 Motorized Convex, 4d114-5/38 Motorized Linear, 4DEC9/5 Motorized Microconvex Endocavity, T7-4 Transesophageal Phased Array, TEM7-3/9 Transesophageal, mTEE8-3/5 Transesophageal, TEEIMA Transesophageal, IOT9-5/40 Convex Intraoperational, M4DC7-3/40 Motorized Convex, and L40-8/12 Linear.

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 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

7

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.

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

Sincerely Yours,

Mary S. Redill

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

8

Indications for Use Form

510(k) Number (if known): K | 12726

Device Name: Sonix Ultrasound Scanner

Indications for Use:

The Sonix Ultrasound Scanner 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.

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 dataobtained by a physician for clinical diagnosis purposes.

X Prescription Use Over-The-Counter Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

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

Mary S. Patil
Division Sign off

Division Sign-C Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112726

। Page 1 of

-"
1

9

Sonix 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
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic	P	P	P	P	P	P	P	P[3-6,8]
Fetal	P	P	P	P	P	P	P	P[3-8,11]
Abdominal	P	P	P	P	P	P	P	P[3-8,11]
Intraoperative1	P	P	P	P	P	P	P	P[3-8]
Intraoperative Neurological	P	P	P	P	P	P	P	P[3-8]
Pediatric	P	P	P	P	P	P	P	P[3-6,8,11]
Small Organ2	P	P	P	P	P	P	P	P[3-8,11]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8,11]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8,11]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal	P	P	P	P	P	P	P	P[3-6,8]
Transrectal	P	P	P	P	P	P	P	P[3-8,11]
Transvaginal	P	P	P	P	P	P	P	P[3-8,11]
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular	P	P	P	P	P	P	P	P[3-8,11]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-8,11]
MSK Superficial	P	P	P	P	P	P	P	P[3-8,11]
Vascular Access	P	P	P	P	P	P	P	P[3-8,10,11]
Nerve Block	P	P	P	P	P	P	P	P[3-9,11]
Other

N = New indication; P = Previously cleared under K093462

Notes :

• Abdominal organs and vascular 1
• Breast, Thyroid, Testicle 2
• Elastography 3
• Panoramic Imaging র্ব
• 5 Compound Imaging
• Freehand 3D Imaging 6
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of biopsy
• g Imaging for guidance of nerve block injections
• Imaging for guidance of central or peripheral lines 10
• Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 11
• 12 B/PW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

1

Prescription Use Only

Mary S. Postel

---

(Division Sign-Off)

510K

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

10

SA4-2/24 Phased Array Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative¹
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ²
Neonatal Cephalic	P	P	P		P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography ઉ
• য Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• റ്റ Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Doppler (Triplex CW), B/Power Doppier/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

Prescription Use Only

2

Mary Pastel
(Division Sign-Off)

SONIX User Manual

Division of Badiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112726

11

SA3-1/24 Phased Array Transducer

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

| Clinical Application | Mode of Operation | | | | | | | | Other
[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|----------|------------------|
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes12 | | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] | |
| Intraoperative1 | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] | |
| Small Organ2 | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P[3-6,8] | |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] | |
| Cardiac | P | P | P | P | P | P | P | P[3-6,8] | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P[3-6,8] | |
| Peripheral Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| MSK Conventional | | | | | | | | | |
| MSK Superficial | | | | | | | | | |
| Vascular Access | | | | | | | | | |
| Nerve Block | | | | | | | | | |
| Other | | | | | | | | | |

N = New indication; P = Previously cleared under K093462

Notes:

• Abdominal organs and vascular 1
• Breast, Thyroid, Testicle 2
• Elastography 3
• ব Panoramic Imaging
• 5 Compound Imaging
• ଚ Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• റ്റ Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), BiPower Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

3

Appendix C: Transdcuer Specifications

Prescription Use Only

Mary S. Patel

---

(Division Sign Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112706

12

PA4-2/20 Phased Array Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative¹
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ²
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography 3
• 4 Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging റ്റ്
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of biopsy
• 9 Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BIM, BIPW Dopler or CW Dopler (Triplex) or CW Doppler (Triplex CW), BIPower Doppler/PW Dopler or CW Doppler, Simultaneous Cotor Doppler or Power Doppler

す

Appendix C: Transdcuer Specifications

Prescription Use Only

(Division Sign-Off)

Division of Radiological Devices Office of In itro Diagnostic Device Evaluation and Safety

510K KILAUAC

SONIX User Manual

13

PA7-4 Phased Array Transducer

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

| Clinical Application | Mode of Operation | | | | | | | Other
[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes12 | |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] |
| Small Organ2 | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P[3-6,8] |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Cardiac | P | P | P | P | P | P | P | P[3-6,8] |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P[3-6,8] |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography ਤੇ
• 4 Panoramic Imaging
• 5 Compound Imaging
• 6 Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• 8 lmaging for guidance of biopsy
• Imaging for guidance of nerve block injections റ്റ
• Imaging for guidance of central or peripheral lines 10
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), BIPower Doppler/PW Doppler/PW Dopper or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

5

Appendix C: Transdcuer Specifications

Mary Pastel

(Division Sign On)

sion Sign-Of Division of Radiological Devices Office of In Juation and Safety

510K K112726

14

C5-2/60 and C5-2/60 GPS Convex Transducers

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

| Clinical Application | Mode of Operation | | | | | | | Other
[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes12 | |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P[3-6,8,11] |
| Abdominal | P | P | P | | P | P | P | P[3-6,8,11] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[3-6,8,11] |
| Small Organ2 | P | P | P | | P | P | P | P[3-6,8,11] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[3-6,8,11] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[3-6,8,11] |
| MSK Superficial | P | P | P | | P | P | P | P[3-6,8,11] |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |

N = New indication; P = Previously cleared under K093462

Notes:

• Abdominal organs and vascular 1
• Breast, Thyroid, Testicle 2
• Elastography 3
• Panoramic Imaging 4
• ട Compound Imaging
• Freehand 3D Imaging 6
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of biopsy
• മ Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Dopler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

Prescription Use Only

Mary S. Patil

(Div sion Sign-Division of Radiologic Office of In raluation and Safety

510K Kบลาวช

SONIX User Manual

6

15

C5-2/40 Convex Transducer

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

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes12 | Other
[Notes] |
|-----------------------------|---|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P[3-6,8] |
| Abdominal | P | P | P | | P | P | P | P[3-6,8] |
| Intraoperative¹ | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[3-6,8] |
| Small Organ² | P | P | P | | P | P | P | P[3-6,8] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[3-6,8] |
| MSK Superficial | P | P | P | | P | P | P | P[3-6,8] |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |

N = New indication; P = Previously cleared under K093462

Notes :

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography 3
• র্ব Panoramic Imaging
• ર Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• Imaging for guidance of biopsy 8
• ക Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

7

Appendix C: Transdcuer Specifications

Man S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In

510K KULAC

16

C7-3/50 Convex Transducer

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

	Mode of Operation
Clinical Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-6,8]
Abdominal	P	P	P		P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-6,8]
Small Organ2	P	P	P		P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P		P	P	P	P[3-6,8]
Adult Cephalic	P	P	P		P	P	P	P[3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-6,8]
MSK Superficial	P	P	P		P	P	P	P[3-6,8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• Abdominal organs and vascular 1
• 2 Breast, Thyroid, Testicle
• Elastography 3
• এ Panoramic Imaging
• 5 Compound Imaging
• 6 Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• Imaging for guidance of biopsy છ
• 9 Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopter (Triplex CW), B/Power Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

8

Appendix C: Transdcuer Specifications

Mary S. Roth
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112726

SONIX User Manual

17

MC9-4/12 Microconvex Transducer

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

	Mode of Operation
Clinical Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P[3-6,8]
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2	P	P	P	P	P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular	P	P	P	P	P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-6,8]
MSK Superficial	P	P	P	P	P	P	P	P[3-6,8]
Vascular Access	P	P	P	P	P	P	P	P[3-6,8,10]
Nerve Block	P	P	P	P	P	P	P	P[3-6,8,9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

• Abdominal organs and vascular 1
• Breast, Thyroid, Testicle 2
• Elastography 3
• র্ব Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections 9
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BIM, BIPW Doppler or CW Dopler (Triplex) or CW Dopter (Triplex CW), BPOwer Doppler/PW Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

9

SONIX User Manual

Appendix C: Transdcuer Specifications

Mary S. Pastl

(Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K KII2A26

18

EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity Transducers

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

Clinical Application	Mode of Operation								Other [Notes]
	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	Combined Modes12
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P		P	P	P	P[3-6,8,11]
Transvaginal	P	P	P		P	P	P	P[3-6,8,11]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography ਤੇ
• ধ Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging ଚ
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of biopsy
• 9 Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CV), B/Power Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

10

Appendix C: Transdcuer Specifications

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. Kilana

SONIX User Manual

SONIX User Manual

19

L9-4/38 Linear Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P[3-6,8]
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2	P	P	P	P	P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P	P	P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-6,8]
MSK Superficial	P	P	P	P	P	P	P	P[3-6,8]
Vascular Access	P	P	P	P	P	P	P	P[3-6,8,10]
Nerve Block	P	P	P	P	P	P	P	P[3-6,8,9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

• Abdominal organs and vascular 1
• Breast, Thyroid, Testicle 2
• Elastography 3
• র্ণ Panoramic Imaging
• ર Compound Imaging
• Freehand 3D Imaging ଚି
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of blopsy
• g Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

Prescription Use Only

11

Appendix C: Transdcuer Specifications

Mary S. Pastel

ivision Sian-Off Division of Radiological Devices Office of In Vitro Diagnostic D nd Safety

510K K11272C

20

L14-5/38 and L14-5/38 GPS Linear Transducers

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
(Notes)
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-6,8,11]
Abdominal	P	P	P		P	P	P	P[3-6,8,11]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-6,8,11]
Small Organ2	P	P	P		P	P	P	P[3-6,8,11]
Neonatal Cephalic	P	P	P		P	P	P	P[3-6,8,11]
Adult Cephalic	P	P	P		P	P	P	P[3-6,8,11]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[3-6,8,11]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-6,8,11]
MSK Superficial	P	P	P		P	P	P	P[3-6,8,11]
Vascular Access	P	P	P		P	P	P	P[3-6,8,10,11]
Nerve Block	P	P	P		P	P	P	P[3-6,8,9,11]
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography ന
• प Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• 9 Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopter (Triplex CW), BPPower Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

12

Appendix C: Transdcuer Specifications

Prescription Use Only

Mary S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic De Evaluation and Safety

510K. Kucnac

SONIX User Manual

21

L14-5W/60 Wide Linear Transducer

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

| Clinical Application | Mode of Operation | | | | | | | Other
[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes12 | |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P[3-6,8] |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] |
| Small Organ2 | P | P | P | P | P | P | P | P[3-6,8] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P[3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | P | P | P | P | P[3-6,8] |
| MSK Superficial | P | P | P | P | P | P | P | P[3-6,8] |
| Vascular Access | P | P | P | P | P | P | P | P[3-6,8,10] |
| Nerve Block | P | P | P | P | P | P | P | P[3-6,8,9] |
| Other | | | | | | | | |

N = New indication; P = Previously cleared under K093462

Notes:

• Abdominal organs and vascular 1
• Breast, Thyroid, Testicle 2
• Elastography 3
• র্ব Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• imaging for guidance of nerve block injections ರಿ
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BM, BIPW Doppler or CW Dopler, BIC/PW Dopler (Triplex) or CW Dopler (Triplex CW), BIPower Doppler/PW Doppier or CW Doppler, Simultaneous Color Doppler or Power Doppler

13

SONIX User Manual

Appendix C: Transdcuer Specifications

Mury S. Patil
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagno aluation and Safety

510K K112726

22

L15-8/26 Linear Transducer

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

| Clinical Application | B | M | PW Doppler | CW Doppler | Color Doppler | Power Doppler | Combined Modes12 | Other
(Notes) |
|-----------------------------|---|---|------------|------------|---------------|---------------|------------------|------------------|
| Ophthalmic | P | P | P | P | P | P | P | P[3-6,8] |
| Fetal | P | P | P | | P | P | P | P[3-6,8] |
| Abdominal | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | P | P | P | | P | P | P | P[3-6,8] |
| Pediatric | P | P | P | | P | P | P | P[3-6,8] |
| Small Organ2 | P | P | P | | P | P | P | P[3-6,8] |
| Neonatal Cephalic | P | P | P | | P | P | P | P[3-6,8] |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | P | P | P | | P | P | P | P[3-6,8] |
| Peripheral Vascular | P | P | P | | P | P | P | P[3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[3-6,8] |
| MSK Superficial | P | P | P | | P | P | P | P[3-6,8] |
| Vascular Access | P | P | P | | P | P | P | P[3-6,8,10] |
| Nerve Block | P | P | P | | P | P | P | P[3-6,8,9] |
| Other | | | | | | | | |

N = New indication; P = Previously cleared under K093462

Notes :

• Abdominal organs and vascular 1
• Breast, Thyroid, Testicle 2
• 3 Elastography
• ব Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging ଚ
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections ರಿ
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BM, BIPW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

Prescription Use Only

14

Mary S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic D

510K K112726

SONIX User Manual

23

BPL9-5/55 Linear Endocavity Biplane Transducer

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

	Mode of Operation
Clinical Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes¹²	Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative¹
Intraoperative Neurological
Pediatric
Small Organ²
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	P	P[3-6,8]
Transvaginal	P	P	P	P	P	P	P	P[3-6,8]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography 3
• 4 Panoramic Imaging
• ട Compound Imaging
• Freehand 3D Imaging e
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections 9
• 10 Imaging for guidance of central or peripheral lines
• Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 11
• 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Dopler/PW Dopler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

15

Appendix C: Transdcuer Specifications

Mary S. Patil

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices

510K K112726

24

BPC8-4/10 Microconvex Endocavity Biplane Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative¹
Intraoperative Neurological
Pediatric
Small Organ²
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	P	P[3-6,8]
Transvaginal	P	P	P	P	P	P	P	P[3-6,8]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography 3
• Panoramic Imaging ঞ্চ
• 5 Compound Imaging
• Freehand 3D Imaging ଚ
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections 9
• 10 tmaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler/PW Doppler/ or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

Prescription Use Only

16

Mary S. Patil

(Dision Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K Kuาว6

SONIX User Manual

25

HST15-8/20 Linear Transducer

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

	Mode of Operation
Clinical Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic	P	P	P	P	P	P	P	P[3-6,8]
Fetal	P	P	P	P	P	P	P	P[3-6,8]
Abdominal
Intraoperative1
Intraoperative Neurological	P	P	P	P	P	P	P	P[3-6,8]
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2	P	P	P	P	P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular	P	P	P	P	P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-6,8]
MSK Superficial	P	P	P	P	P	P	P	P[3-6,8]
Vascular Access	P	P	P	P	P	P	P	P[3-6,8,10]
Nerve Block	P	P	P	P	P	P	P	P[3-6,8,9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography રુ
• Panoramic Imaging র্ণ
• 5 Compound imaging
• Freehand 3D Imaging e
• Live 3D/4D Imaging 7
• రి Imaging for guidance of biopsy
• g Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 11
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

Prescription Use Only

17

Mary S. Patel
(Division Sign-Off)

Appendix C: Transdcuer Specifications

Division of Radiological Devices iffice of In Vitro Diagnostic Devi n and Safety

510K K112726

26

4DC7-3/40 Motorized Convex Transducer

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

	Mode of Operation
Clinical Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-8]
Abdominal	P	P	P		P	P	P	P[3-8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-8]
Small Organ2	P	P	P		P	P	P	P[3-8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[3-8]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-8]
MSK Superficial	P	P	P		P	P	P	P[3-8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• 3 Elastography
• ব Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging રિ
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of biopsy
• த Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Doppler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

Prescription Use Only

18

Mary S Patil
(Division Sign-Off)

Division of Radiological Office of In Vitro Diagno

SONIX User Manual

510K K12226

27

4DL14-5/38 Motorized Linear Transducer

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

	Mode of Operation
Clinical Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined12
Modes	Other
[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-8]
Abdominal	P	P	P		P	P	P	P[3-8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-8]
Small Organ2	P	P	P		P	P	P	P[3-8]
Neonatal Cephalic	P	P	P		P	P	P	P[3-8]
Adult Cephalic	P	P	P		P	P	P	P[3-8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-8]
MSK Superficial	P	P	P		P	P	P	P[3-8]
Vascular Access	P	P	P		P	P	P	P[3-8,10]
Nerve Block	P	P	P		P	P	P	P[3-9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography રે
• Panoramic imaging イ
• 5 Compound Imaging
• Freehand 3D Imaging ନ
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections g
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

19

SONIX User Manual

Prescription Use Only

Mary S Pastel
(Division Sign-Off)

Appendix C: Transdcuer Specifications

Division of Radiological Devices Office of In Vitro Diagno ion and Safaty

510K B112726

28

4DEC9-5/10 Motorized Microconvex Endocavity Transducer

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

| Clinical Application | Mode of Operation | | | | | | | | Other
[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|--------------------|--------|------------------|
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes2 | | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intraoperative1 | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ2 | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | P[3-8] | |
| Transvaginal | P | P | P | P | P | P | P | P[3-8] | |
| Transurethral | | | | | | | | | |
| Transcranial | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| MSK Conventional | | | | | | | | | |
| MSK Superficial | | | | | | | | | |
| Vascular Access | | | | | | | | | |
| Nerve Block | | | | | | | | | |
| Other | | | | | | | | | |

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• 3 Elastography
• Panoramic Imaging ব
• 5 Compound Imaging
• Freehand 3D Imaging 6
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of biopsy
• g Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Doppler (Triplex) or CW Dopsler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

Prescription Use Only

20

SONIX User Manual

Mary S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluation and Sefety

510K B112726

29

T7-4 Transesophageal Phased Array Transducer

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

	Mode of Operation
Clinical Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative¹
Intraoperative Neurological
Pediatric
Small Organ²
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	P	P	P	P	P[3-6,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography 3
• ব Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• ക !maging for guidance of nerve block injections
• Imaging for guidance of central or peripheral lines 10
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Doplar (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

Prescription Use Only

21

Mary S. Padell

Appendix C: Transdcuer Specifications

Division Sign-Off) Division of Radiological Devices Office of In Vitro D and Safety

510K Kuวา26

30

TEM7-3/9 Transesophageal Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notas]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	P	P	P	P	P[3-6,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• 2 Breast, Thyroid, Testicle
• Elastography ദ
• Panoramic Imaging す
• ട Compound Imaging
• Freehand 3D Imaging ଚ
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• g Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BM, BIPW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), BPower Doppler(PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

22

Appendix C: Transdcuer Specifications

Prescription Use Only

Mary S. Padilla
Division Sign Off

Pinsion of Bladiological ce of In Vitro Diago and Selety

K112726

SONIX User Manual

11

",一个

31

mTEE8-3/5 Transesophageal Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	P	P	P	P	P[3-6,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography ന
• ব Panoramic Imaging
• ર Compound Imaging
• Freehand 3D Imaging હ
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• ರಿ Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BIM, B/PW Dopler or CW Dopler B/C/PW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

23

Appendix C: Transdcuer Specifications

Mary S. Patil
(Division Sign Off)

(Division Sign-Off Division of Radiological Devices Office of In Vitro Dr ce Evaluation and Safety

510K K112726

32

TEEIMA Transesophageal Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative¹
Intraoperative Neurological
Pediatric
Small Organ²
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	P	P	P	P	P[3-6,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• 2 Breast, Thyroid, Testicle
• Elastography 3
• प Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• Imaging for guidance of biopsy 8
• 9 Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BM, BIPW Doppler or CW Doppler (Triplex) or CW Doppler (Triplex CVV), BPower Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

Prescription Use Only

24

SONIX User Manual

Mary Stattl
(Division Sign Off)

Pivision of Radio

K112726

33

IOT9-5/40 Convex Intraoperational Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P[3-8]
Abdominal	P	P	P	P	P	P	P	P[3-8]
Intraoperative1	P	P	P	P	P	P	P	P[3-8]
Intraoperative Neurological	P	P	P	P	P	P	P	P[3-8]
Pediatric	P	P	P	P	P	P	P	P[3-8]
Small Organ2	P	P	P	P	P	P	P	P[3-8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	P	P[3-8]
Transvaginal	P	P	P	P	P	P	P	P[3-8]]
Transurethral
Transcranial
Peripheral Vascular	P	P	P	P	P	P	P	P[3-8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-8]
MSK Superficial	P	P	P	P	P	P	P	P[3-8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography 3
• Panoramic Imaging র্ব
• 5 Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections த
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler/PW Doppier/PW Doppier or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

Prescription Use Only

25

Mary S Pastel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Appendix C: Transdcuer Specifications

510K K112726

34

m4DC7-3/40 Motorized Convex Transducer

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

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes12 | Other
[Notes] |
|-----------------------------|---|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | N[3-8] |
| Abdominal | N | N | N | N | N | N | N | N[3-8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N[3-8] |
| Small Organ2 | N | N | N | N | N | N | N | N[3-8] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | N | N | N | N | N | N | N | N[3-8] |
| MSK Superficial | N | N | N | N | N | N | N | N[3-8] |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |

N = New indication; P = Previously cleared

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• ও Elastography
• Panoramic Imaging ব
• 5 Compound Imaging
• 6 Freehand 3D Imaging
• Live 3D/4D Imaging 7
• Imaging for guidance of biopsy છ
• ക Imaging for guidance of nerve block injections
• 10 Imaging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 B/M, B/PW Doppler or CW Doppler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

Prescription Use Only

26

SONIX User Manual

(Disision Sign-Off

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K Kuara26

35

L40-8/12 Linear Transducer

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

Clinical Application	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes12	Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological	N	N	N		N	N	N	N[3-6,8]
Pediatric	N	N	N		N	N	N	N[3-6,8]
Small Organ2	N	N	N		N	N	N	N[3-6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	N	N	N		N	N	N	N[3-6,8]
Laparoscopic
MSK Conventional	N	N	N		N	N	N	N[3-6,8]
MSK Superficial	N	N	N		N	N	N	N[3-6,8]
Vascular Access	N	N	N		N	N	N	N[3-6,8,10]
Nerve Block	N	N	N		N	N	N	N[3-6,8,9]
Other

N = New indication; P = Previously cleared

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography 3
• 4 Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging હ
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections 9
• 10 Imaging for guidance of central or peripheral lines
• Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 11
• 12 BIM, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

27

Prescription Use Only

May S. Patil
(Division Sign-Off)

Division of Radiological Devices Evaluation and Safety Office of In Vitro Diag

Appendix C: Transdcuer Specifications

510K. K112726