SONIX ULTRASOUND SCANNER

• K Number: K093462
• Device Name: SONIX ULTRASOUND SCANNER
• Manufacturer: UltraSonix Medical Corporation
• Date Cleared: 2009-11-20 ( 14 days)
• Product Code: ITX IYN IYO
• Regulation Number: 892.1570

Intended 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, peribheral 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 Morde, 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 guides 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 guides, sterile sheaths, ultrasound transmission gel, and bands.

Predicate Devices

K083095, K080935, K082185, K974432, K070244, K053069, K062247, K060993, K080223, K072786, K061215

Reference Devices

Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935), GE Logiq E9 (K082185), Ultraguide 1000 (K974432), Aegis (K070244), 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)

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms in the device description or other sections. The functionality described is standard for diagnostic ultrasound systems.

Therapeutic

No.
The device description and intended use clearly state that it is a diagnostic ultrasound imaging system, used for acquiring and displaying ultrasound echo data for clinical diagnosis purposes, not for treating conditions.

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 / Indications for Use" section mentions that the calculation packages provide information that "may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." The "Mentions image processing" section also confirms that the device "yields an ultrasound image in realtime for diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as the "Sonix Ultrasound Scanner," "Flat Panel Display," "computer keyboard," "touch panel," "ECG cable assembly," and "probes." It also describes physical accessories like "biopsy kits" and "polymeric brackets." This indicates it is a hardware system with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
• Device Function: The Sonix Ultrasound Imaging System is a diagnostic ultrasound system. It acquires and displays ultrasound echo data to create images of internal anatomical structures. This is an in vivo imaging technique, meaning it is performed on a living organism, not on a specimen outside the body.
• Intended Use: The intended uses listed are all related to imaging various parts of the body directly, not analyzing biological samples.
• Device Description: The description focuses on the ultrasound technology, probes, display modes, and measurement capabilities, all of which are characteristic of an in vivo imaging system.
• Lack of Specimen Handling: There is no mention of handling or analyzing biological specimens.

Therefore, the Sonix Ultrasound Imaging System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

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, peribheral 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 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 Morde, 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 guides 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 guides, sterile sheaths, ultrasound transmission gel, and bands.

Mentions image processing

Not Found

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.

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)

Not Found

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

Not Found

Predicate Device(s)

Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935), GE Logiq E9 (K082185), Ultraguide 1000 (K974432), Aegis (K070244), 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)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

0

K093462

510 (k) Summary for the Sonix 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

NOV 2 0 2009

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

October 10, 2008

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 TOUCH Ultrasound Scanner (K083095) SONIX MDP Ultrasound Scanner (K080935) GE Logiq E9 (K082185) Ultraguide 1000 (K974432) Aegis (K070244) 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:

Clearance request for:

Sonix Ultrasound Scanner and the cleared transducers with additional/expanded indication for use:

• Imaging of guidance of central or peripheral lines; .
• Imaging for guidance of biopsy; ●
• Imaging for guidance of nerve block injections; .
• Volume Navigation/ Image Fusion/ GPS .
• Panoramic imaging: .
• Compound imaging; .
• Elastography. .

New Transducers:

• SA4-2/24 .
• SA3-1/24 .
• 4DL14-5/38
• 4DEC9-5/10
• MC9-4/12
• HST15-8/20
• L15-8/26
• TEM7-3/9
• TEM10-7/5
• TEEIMA .

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 Morde, 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 guides 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 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 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, peribheral 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 TOUCH Ultrasound Scanner (K083095) Sonix MDP Ultrasound Scanner (K080935) Ultraguide 1000 (K974432) GE Logia E9 (K082185) Aegis (K070244)

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

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 (1992)" published by the National Electrical Manufacturers Association as UD-3.

With respect to limits on acoustic outputs, the Sonix 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 Sonix Ultrasound Scanner is designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and EC 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)

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The limits are the same as predicate Track 3 devices.

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Image /page/6/Picture/1 description: The image shows a logo for the Department of Health & Human Services - CSA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - CSA" arranged around the circumference. Inside the circle is a stylized graphic of a bird or abstract human figure with outstretched arms, possibly representing care or support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

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

NOV 2 0 2009

Re: K093462

Trade/Device Name: Sonix 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: November 5, 2009 Received: November 6, 2009

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 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

SA4-2/24 Phased Array C7-3/50 Convex SA3-1/24 Phased Array MC9-4/12 Microconvex PA4-2/20 Phased Array PA7-4 Phased Array L9-4/38 Linear C5-2/60 and C5-2/60 GPS Convex

EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity L14-5/38 and L14-5/38 GPS Linear

7

Page 2 - Mr. Mark Job

C5-2/40 Convex	L14-5W/60 Wide Linear
L15-8/26 Linear	4DEC9-5/10 Motorized Microconvex Endocavity
BPSL9-5/55-10L Linear Endocavity Biplane	T7-4 Transesophageal Phased Array
BPSL9-5/55-10C Microconvex Endocavity Biplane	TEM7-3/9 Transesophageal
HST15-8/20 Linear	TEM10-7/5 Transesophageal
4DC7-3/40 Motorized Convex	TEEIMA Transesophageal
4DL14-5/38 Motorized Linear	IOT9-5/40 Convex Intraoperational

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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 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.

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Page 3 - Mr. Mark Job

If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at [phone].

Sincerely yours,

Arzu M. Whay

ריין

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: Sonix Ultrasound Scanner Indications For Use:

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

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

Prescription Use X (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)

---

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K093462

Page 1 of

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Sonix Ultrasound Scanner - Diagnostic Ultrasound Indications for Use Form

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	N	N	N	N	N	N	N	N[3-6,8]
Feta!	P	P	P	N	P	P	P	P[6-8] N[3-5,11]
Abdominal	P	P	P	P	P	P	P	P[6-8] N[3-5,11]
Intraoperative1	P	P	P	P	P	P	P	P[6,7] N[3-5,8]
Intraoperative Neurological	P	P	P	P	P	P	P	P[6,7] N[3-5,8]
Pediatric	P	P	P	P	P	P	P	P[6-8] N[3-5,11]
Small Organ2	P	P	P	N	P	P	P	P[6-8] N[3-5,11]
Neonatal Cephalic	P	P	P	N	P	P	P	P[3-6,8] N[11]
Adult Cephalic	P	P	P	N	P	P	P	P[3-6,8] N[11]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal	P	P	P	N	P	P	P	P[3-6,8]
Transrectal	P	P	P	N	P	P	P	P[6-8] N[3-5,11]
Transvaginal	P	P	P	N	P	P	P	P[6-8] N[3-5,11]
Transurethral
Transcranial	P	P	P	N	P	P	P	P[3-6,8]
Peripheral Vascular	P	P	P	N	P	P	P	P[6-8] N[3-5,11]
Laparoscopic
MSK Conventional	P	P	P	N	P	P	P	P[6-8] N[3-5,11]
MSK Superficial	P	P	P	N	P	P	P	P[6-8] N[3-5,11]
Vascular Access	N	N	N	N	N	N	N	N[3-8,10,11]
Nerve Block	N	N	N	N	N	N	N	N[3-9,11]
Other

N = New indication; P = Previously cleared under K061827

Notes:

• 1 Abdominal organs and vascular
  Breast, Thyrold, Testicle 2

• Elastography 3

• ব Panoramic Imaging

5 Compound Imaging

Freehand 3D Imaging 6

7 Live 3D/4D Imaging

8 , Imaging for guidance of blopsy

டு Imaging for guidance of nerve block injections

10 Imaging for guldance of central or peripheral lines

Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 11

B/M, B/PW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler

1

(Division Si Division of Reproductive, Abdominal, and Radiological De 510(k) Number

11

. SA4-2/24 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	N	N	N	N	N	N	N	N[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N	N[3-6,8]
Small Organ2
Neonatal Cephalic	N	N	N	N	N	N	N	N[3-6,8]
Adult Cephalic	N	N	N	N	N	N	N	N[3-6,8]
Cardiac	N	N	N	N	N	N	N	N[3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	N	N	N	N	N	N	N	N[3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared

Notes:

• Abdominal organs and vascular 1
• 2 Breast, Thyrold, Testicle
• 3 Elastography
• Panoramic Imaging 4
• 5 Compound Imaging
• க Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of blopsy
• g
• Imaging for guidance of nerve block injections 10 Imaging for guidance of cantral or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).

BIM, BIPW Dopler or CW Dopler, of Crevillone in Crisit of CH Dopler (Triplex CW), BPower Doppler/PW Doppler or CW
Dopler, Simultageum Color Deven Deselec 12 Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

2

SONIX User Manual

Lorn Th Nhg

(Division Sigr Division of Reproductive, Abdomi and Radiological Devi 510(k) Number

510(k) Number_

12

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

N = New indication; P = Previously cleared

Notes:

Abdominal organs and vascular t

Breast, Thyrold, Testicle 2

3 Elastography

Panoramic Imaging 4

Compound Imaging ર

6 Freehand 3D Imaging

7 Live 3D/4D Imaging

lmaging for guldance of biopsy 8

a Imaging for guidance of nerve block Injections

10 lmaging for guidance of central or peripheral lines

11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).

Polling Nation Pingle Pusion of State Printer the GFS transdicer).
BM, BPW Dopler or CW Dopler (Triplex) or CW Dopler (Triplex CW), BiPower Dopler/PW Dopler or CW
Dopler, 12 Doppler, Simultaneous Color Doppler or Power Doppler

3

SONIX User Manual

Appendix C: Transducer Specifications

Tony M. Whig

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

510(k) Number K093462

13

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 | | | | | | | | 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[6] N[3-5,8] | |
| Intraoperative1 | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[6] N[3-5,8] | |
| Small Organ2 | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P[6] N[3-5,8] | |
| Adult Cephalic | P | P | P | N | P | P | P | P[6] N[3-5,8] | |
| Cardiac | P | P | P | P | P | P | P | P[6] N[3-5,8] | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Transcranial | P | P | P | N | P | P | P | P[6] N[3-5,8] | |
| Peripheral Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| MSK Conventional | | | | | | | | | |
| MSK Superficial | | | | | | | | | |
| Vascular Access | | | | | | | | | |
| Nerve Block | | | | | | | | | |
| Other | | | | | | | | | |

N = New indication; P = Previously cleared under K061827

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography ਤ
• 4 Panoramic Imaging
• 5 Compound Imaging
• ট Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• lmaging for guldance of biopsy 8
• 9 Imaging for guldance 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).
• BIM, BIPW Doppler, BIC/PW Doppler, B/C/PW Doppler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler

4

Appendix C: Transdcuer Specifications

SONIX User Manual

Tony M. Whay

(Division Sign Division of Reproductive, and Radiological Devi 510(k) Number

14

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
	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[6] N[3-5,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[6] N[3-5,8]
Small Organ2
Neonatal Cephalic	P	P	P		P	P	P	P[6] N[3-5,8]
Adult Cephalic	P	P	P	N	P	P	P	P[6] N[3-5,8]
Cardiac	P	P	P	P	P	P	P	P[6] N[3-5,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	N	P	P	P	P[6] N[3-5,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K061827

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyrold, Testicle 2
• Elastography 3
• র্ণ Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging රි
• 7 Live 3D/4D Imaging
• 8 Imaging for guldance 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).

B/M, B/PW Dopler or CW Dopler (T/C/PW Dopler (Triplex) or C Guillousel).
Donaler Simulaneous Color Dopler (Tiplex) or CW Dopler (Triplex CW), B/Power Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

Prescription Use Only

5

louis to wh

(Division S Division of Reproductive, Abdominal and Radiological De 510(k) Number

Appendix C: Transdcuer Specifications

15

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[6,8] N[3-5,11] | |
| Abdominal | P | P | P | | P | P | P | P[6,8] N[3-5,11] | |
| Intraoperative¹ | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[6,8] N[3-5,11] | |
| Small Organ2 | P | P | P | | P | P | P | P[6,8] N[3-5,11] | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Transcranial | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[6,8] N[3-5,11] | |
| Laparoscopic | | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[6,8] N[3-5,11] | |
| MSK Superficial | P | P | P | | P | P | P | P[6,8] N[3-5,11] | |
| Vascular Access | | | | | | | | | |
| Nerve Block | | | | | | | | | |
| Other | | | | | | | | | |

N = New indication; P = Previously cleared under K061827

Notes:

• Abdominal organs and vascular 1
  2 Breast, Thyrold, Testicle

• 3 Elastography

• Panoramic Imaging 4

• ર Compound Imaging

• க Freehand 3D Imaging

• Live 3D/4D Imaging 7

• 8 lmaging for guidance of biopsy

• 9 lmaging for guldance of nerve block injections

10 Imaging for guidance of central or peripheral lines

11 Volume Navigation / Image Fuslon / GPS (available only with the GPS transducer).

entiller de light of Color of O Quiliado only with of GT ST Gransdoel).
BM, BPW Doppler of CW Dopler BVCPW Dopler (Triplex) or CW Doppler (Triplex CW), BPower Dopler/PW Dopp

e

Appendix C: Transdcuer Specifications

SONIX User Manual

loris M. White

(Division S ign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number

16

C5-2/40 Convex 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[6] N[3-5,8] | |
| Abdominal | P | P | P | | P | P | P | P[6] N[3-5,8] | |
| Intraoperative1 | P | P | P | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[6] N[3-5,8] | |
| Small Organ2 | P | P | P | | P | P | P | P[6] N[3-5,8] | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Transcranial | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[6] N[3-5,8] | |
| Laparoscopic | | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[6] N[3-5,8] | |
| MSK Superficial | P | P | P | | P | P | P | P[6] N[3-5,8] | |
| Vascular Access | | | | | | | | | |
| Nerve Block | | | | | | | | | |
| Other | | | | | | | | | |

N = New indication; P = Previously cleared under K061827

.

Notes:

• Abdominal organs and vascular 1
• 2 Breast, Thyroid, Testicle
• Elastography 3
• 4 Panoramic Imaging
• ર Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• 8 Imaging for guldance of biopsy
• 8 Imaging 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

BM, B/W Dopler on CW Dopler (Thile GP S Valisuce).
B/M, B/PW Dopler on CW Dopler (Thplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW
Dopler, Slimultaneous Doppler, Simultaneous Color Doppler or Power Doppler

7

SONIX User Manual

Appendix C: Transducer Specifications

Lurpi Th. Wh.

(Divisio -Off Division of Reproductive, Abdominal and Radiological Dev 510(k) Number

17

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[6,8] N[3-5]
Abdominal	P	P	P		P	P	P	P[6,8] N[3-5]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[6,8] N[3-5]
Small Organ2	P	P	P		P	P	P	P[6,8] N[3-5]
Neonatal Cephalic	P	P	P		P	P	P	P[6,8] N[3-5]
Adult Cephalic	P	P	P		P	P	P	P[6.8] N[3-5]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[6,8] N[3-5]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[6,8] N[3-5]
MSK Superficial	P	P	P		P	P	P	P[6,8] N[3-5]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K061827

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyrold, Testicle 2
• 3 Elastography
• 4 Panoramic Imaging
• 5 Compound Imaging
• ર Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of blopsy
• છે
• 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).

BM, BPW Dopler or CW Dopler, DV QVW Dopler (Thplex) or CV Dopler (Triplex CW), BiPower Doppler)PW Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppier

Appendix C: Transdcuer Specifications

8

SONIX User Manual

Prescription Use Only

Lina M. Whig
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devic 510(k) Number

10(k) Number

18

MC9-4/12 Microconvex 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	N	N	N	N	N	N	N	N[3-6,8]
Abdominal	N	N	N	N	N	N	N	N[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N	N[3-6,8]
Small Organ2	N	N	N	N	N	N	N	N[3-6,8]
Neonatal Cephalic	N	N	N	N	N	N	N	N[3-6,8]
Adult Cephalic	N	N	N	N	N	N	N	N[3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	N	N	N	N	N	N	N	N[3-6,8]
Peripheral Vascular	N	N	N	N	N	N	N	N[3-6,8]
Laparoscopic
MSK Conventional	N	N	N	N	N	N	N	N[3-6,8]
MSK Superficial	N	N	N	N	N	N	N	N[3-6,8]
Vascular Access	N	N	N	N	N	N	N	N[3-6,8,10]
Nerve Block	N	N	N	N	N	N	N	N[3-6,8,9]
Other

N = New indication; P = Previously cleared

Notes:

• Abdominal organs and vascular 1
  2 Breast, Thyroid, Testicle

• Elastography 3

• র্ব Panoramic Imaging

• 5 Compound imaging

• 6 Freehand 3D Imaging

• 7 Live 3D/4D Imaging

• 8 Imaging for guidance of blopsy

• 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 Birling of Children and Co (C) (Charles on J misro of O Guiladoor).
BiM, BiPW Dopler of CW Dopler, B/C/PW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler

9

SONIX User Manual

Appendix C: Transdcuer Specifications

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological De 510(k) Number

19

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
	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[6,8] N[3-5,11]
Transvaginal	P	P	P		P	P	P	P[6,8] N[3-5,11]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K061827

Notes :

• Abdominal organs and vascular 1
• 2 Breast, Thyroid, Testicle
• 3 Elastography
• Panoramic Imaging 4
• ર Compound Imaging
• 6 Freehand 3D Imaging
• Live 3D/4D Imaging 7
• 8 Imaging for guidance of biopsy
• റ്റ
• lmaging for guidance of nerve block injections 10 I maging for guidance of central or peripheral lines
• 11 Villame Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BM, BPW Dopler of GM Dopler (Triplex) on Other only Started on Chinadoe).
  12 BM, BPW Dopler CW Dopler (Triplex) or CW Dopler (Triplex CVV), BPower Dopler of CW
  Doppler

Appendix C: Transdcuer Specifications

10

SONIX User Manual

Lopes In Whys
(Division Sign Off)

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

20

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[6,8] N[3-5]
Abdominal	P	P	P		P	P	P	P[6,8] N[3-5]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[6,8] N[3-5]
Small Organ2	P	P	P		P	P	P	P[6,8] N[3-5]
Neonatal Cephalic	P	P	P		P	P	P	P[6,8] N[3-5]
Adult Cephalic	P	P	P		P	P	P	P[6,8] N[3-5]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[6,8] N[3-5]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[6,8] N[3-5]
MSK Superficial	P	P	P		P	P	P	P[6,8] N[3-5]
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 under K061827

Notes:

• Abdominal organs and vascular 1
• Breast, Thyroid, Testicle 2
• 3 Elastography
• 4 Panoramic Imaging
• 5 Compound Imaging
• ക Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• ଚ୍ଚ Imaging for guidance of nerve block injections
• 10 I maging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BM, BPW Doppler, M. GV (Dr.) 20 (Clumbon) Strip Marian Chi) (Triplex CW), B/Power Dopler/PW Dopler/PW Dopler or CW
  Dopler Simultanova Coler Dopler, B/C/PW Doppler (Triple Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

Appendix C: Transdcuer Specifications

Prescription Use Only

louis M. White

(Division S Division of Reproductive, Abdominal, and Radiological De 510(k) Number

11 (

21

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[6,8] N[3-5,11]
Abdominal	P	P	P	P	P	P	P[6,8] N[3-5,11]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[6,8] N[3-5,11]
Small Organ2	P	P	P		P	P	P	P[6,8] N[3-5,11]
Neonatal Cephalic	P	P	P		P	P	P	P[6,8] N[3-5,11]
Adult Cephalic	P	P	P		P	P	P	P[6,8] N[3-5,11]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[6,8] N[3-5,11]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[6,8] N[3-5,11]
MSK Superficial	P	P	P		P	P	P	P[6,8] N[3-5,11]
Vascular Access	N	N	N		N	N	N	N[3-6,8,10,11]
Nerve Block	N	N	N		N	N	N	N[3-6,8,9,11]
Other

N = New indication; P = Previously cleared under K061827

Notes:

• 1 Abdominal organs and vascular
  Breast, Thyroid, Testicle 2

• 3 Elastography

• 4 Panoramic Imaging

• ક Compound Imaging

• ଚ Freehand 3D Imaging

• 7 Live 3D/4D Imaging

• 8 Imaging for guidance of blopsy

• റ്റ Imaging for guldance 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, B/PW Doppler or CW Doppler, B/C/PW Doppler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendlx C: Transdcuer Specifications

12

SONIX User Manual

Lozuih Wh Wh
(Division Sign-Off)

ign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

22

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 | P | P | P | | P | P | P | P[6,8] N[3-5] |
| Fetal | P | P | P | | P | P | P | P[6,8] N[3-5] |
| Abdominal | P | P | P | | P | P | P | P[6,8] N[3-5] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[6,8] N[3-5] |
| Small Organ2 | P | P | P | | P | P | P | P[6,8] N[3-5] |
| Neonatal Cephalic | P | P | P | | P | P | P | P[6,8] N[3-5] |
| Adult Cephalic | P | P | P | | P | P | P | P[6,8] N[3-5] |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[6,8] N[3-5] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[6,8] N[3-5] |
| MSK Superficial | P | P | P | | P | P | P | P[6,8] N[3-5] |
| 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 under K061827

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography 3
• 4 Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging 6
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• 0 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 BM, BPW Doppler or CW Doppler (Triplex) or CW Doppler (Triplex CVV), BPower Doppler(PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

13

SONIX User Manual

Appendix C: Transdcuer Specifications

Lory Ta Wez
(Division Sign-Off)

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

23

L15-8/26 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 | N | N | N | N | N | N | N | N[3-6,8] |
| Fetal | N | N | N | N | N | N | N | N[3-6,8] |
| Abdominal | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | N | N | N | N | N | N | N | N[3-6,8] |
| Pediatric | N | N | N | N | N | N | N | N[3-6,8] |
| Small Organ2 | N | N | N | N | N | N | N | N[3-6,8] |
| Neonatal Cephalic | N | N | N | N | N | N | N | N[3-6,8] |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | N | N | N | N | N | N | N | N[3-6,8] |
| Peripheral Vascular | N | N | N | N | N | N | N | N[3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | N | N | N | N | N | N | N | N[3-6,8] |
| MSK Superficial | N | N | N | N | N | N | N | N[3-6,8] |
| Vascular Access | N | N | N | N | N | N | N | N[3-6,8,10] |
| Nerve Block | N | N | N | N | N | N | N | N[3-6,8,9] |
| Other | | | | | | | | |

N = New indication; P = Previously cleared

Notes:

1

Abdominal organs and vascular 1

Breast, Thyroid, Testicle 2

ತ Elastography

4 Panoramic Imaging

5 Compound Imaging

6 Freehand 3D Imaging

Live 3D/4D Imaging · 7

8 Imaging for guidance of blopsy

ರಿ lmaging for guldance 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/W Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

14

Appendix C: Transdcuer Specifications

SONIX User Manual

louis G. Witz

(Division Sibn-Off Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number K093462

24

BPSL9-5/55-10L Linear 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	N	P	P	P	P[6] N[3-5,8]
Transvaginal	P	P	P	N	P	P	P	P[6] N[3-5,8]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K061827

Notes:

• Abdominal organs and vascular 1
• 2 Breast, Thyroid, Testicle
• Elastography ਤੇ
• Panoramic Imaging 4
• 5 Compound Imaging
• б Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of blopsy
• 8 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, BPW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CVV), BPower Doppler(PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

15

Appendix C: Transducer Specifications

Louh Why
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological De

510(k) Number K093462

25

BPSL9-5/55-10C 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	N	P	P	P	P[6] N[3-5,8]
Transvaginal	P	P	P	N	P	P	P	P[6] N[3-5,8]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K061827

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyroid, Testicle 2
• Elastography ડ
• Panoramic Imaging ব
• 5 Compound Imaging
• 6 Freehand 3D Imaging
• 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 Fuslon / GPS (available only with the GPS transducer).

Brower Collection and Color of Concered on Analo of Canadasar.
BM, B/PW Dopler or C/V Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler or CW
Dopler, Simulaneous 12

Appendix C: Transdcuer Specifications

16

SONIX User Manual

Prescription Use Only

Aong In. Wz

(Division SI Division of Reproductive, Abdominal. and Radiological De 510(k) Number

26

HST15-8/20 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	N	N	N	N	N	N	N	N[3-6,8]
Fetal	N	N	N	N	N	N	N	N[3-6,8]
Abdominal
Intraoperative1
Intraoperative Neurological	N	N	N	N	N	N	N	N[3-6,8]
Pediatric	N	N	N	N	N	N	N	N[3-6,8]
Small Organ2	N	N	N	N	N	N	N	N[3-6,8]
Neonatal Cephalic	N	N	N	N	N	N	N	N[3-6,8]
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	N	N	N	N	N	N	N	N[3-6,8]
Peripheral Vascular	N	N	N	N	N	N	N	N[3-6,8]
Laparoscopic
MSK Conventional	N	N	N	N	N	N	N	N[3-6,8]
MSK Superficial	N	N	N	N	N	N	N	N[3-6,8]
Vascular Access	N	N	N	N	N	N	N	N[3-6,8,10]
Nerve Block	N	N	N	N	N	N	N	N[3-6,8,9]
Other

N = New indication; P = Previously cleared

Notes:

---

• Abdominal organs and vascular 1
  Breast, Thyrold, Testicle 2

• 3 Elastography
  4 Panoramic Imaging

Compound Imaging 5

6 Freehand 3D Imaging

7 Live 3D/4D imaging

8 Imaging for guidance of blopsy

9 Imaging for guldance of nerve block injections

10 Imaging for guildance of central or peripheral lines

11 Volume Navlgation / Image Fusion / GPS (available only with the GPS transducer).

BM, B/PW Dopler or CW Dopler, B/C/PW Doppler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler/PW Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler

SONIX User Manual

Prescription Use Only

17

Appendix C: Transdcuer Specifications

Aoyuta Wh

(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Dey

510(k) Number K093462

27

4DC7-3/40 Motorized Convex 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	Combined12
Modes	Other
[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[6,7] N[3-5,8]
Abdominal	P	P	P		P	P	P	P[6,7] N[3-5,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[6,7] N[3-5,8]
Small Organ2	P	P	P		P	P	P	P[6,7] N[3-5,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[6,7] N[3-5,8]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[6,7] N[3-5,8]
MSK Superficial	P	P	P		P	P	P	P[6,7] N[3-5,8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared K061827

Notes:

• Abdominal organs and vascular 1
• 2 Breast, Thyroid, Testicle
• 3 Elastography
• 4 Panoramic Imaging
• 5 Compound Imaging
• б Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• 8 lmaging for guidance of blopsy
• 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 BM, B/PW Doppler or CW Doplar, B/C/PW Doppler (Triplex CW), B/Power Dopler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler

Appendix C: Transdcuer Specifications

18

SONIX User Manual

Prescription Use Only

Lory 2/21

(Division S n-Off) Division of Reproductive, A and Radiological De 510(k) Number

28

4DL14-5/38 Motorized 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 | N | N | N | | N | N | N | N[3-8] |
| Abdominal | N | N | N | | N | N | N | N[3-8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | N[3-8] |
| Small Organ2 | N | N | N | | N | N | N | N[3-8] |
| Neonatal Cephalic | N | N | N | | N | N | N | N[3-8] |
| Adult Cephalic | N | N | N | | N | N | N | N[3-8] |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | N | N | N | | N | N | N | N[3-8] |
| MSK Superficial | N | N | N | | N | N | N | N[3-8] |
| Vascular Access | N | N | N | | N | N | N | N[3-8,10] |
| Nerve Block | N | N | N | | N | N | N | N[3-9] |
| Other | | | | | | | | |

N = New indication; P = Previously cleared

Notes:

• 1 Abdominal organs and vascular
  Breast, Thyroid, Testicle 2

• Elastography 3

• ব Panoramic Imaging

• 5 Compound Imaging

• ნ Freehand 3D Imaging

• Live 3D/4D Imaging 7

• 8 Imaging for guidance of blopsy

• 9 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

• BM, BIPW Doppler or CW Doppler, B/G/PW Doppler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler/PW Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler

19

SONIX User Manual

Appendix C: Transdcuer Specifications

Prescription Use Only

Vornith Wh

(Divisi Reproductive. Abdominal Division of and Radiolog

510(k) Number

29

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

N = New indication; P = Previously cleared

Notes:

• Abdominal organs and vascular 1
• 2 Breast, Thyroid, Testicle
• 3 Elastography
• Panoramic Imaging ব
• ક Compound imaging
• 6 Freehand 3D Imaging
• Live 3D/4D Imaging 7
• 8
• Imaging for guidance of biopsy ರಿ
• lmaging 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).
• States Canada China Carl Per Quelled only Microsoft of Cruitsadely.
  BM, BPW Dopler or CW Dopler Br Cityw Dopler (Triplex) or CW Dopler (Triplex CW), BPower Dopler or CW
  Do

Appendix C: Transdcuer Specifications

Prescription Use Only

20

SONIX User Manual

(Division Si n-Off)

Division of Reproductive, Abdominal, and Radiological Dev

510(k) Number.

30

T7-4 Transesophageal 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
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	N	P	P	P	P[6] N[3-5,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared K061827

Notes:

• Abdominal organs and vascular 1
• 2 Breast, Thyroid, Testicle
• చ Elastography
• Panoramic Imaging 4
• Compound Imaging 5
• б Freehand 3D Imaging
• 7 Live 3D/4D Imaging
• 8 Imaging for guidance of biopsy
• 9 Imaging for guidance of nerve block injections
• 10 I maging for guidance of central or peripheral lines
• 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
• 12 BM, BPW Dopler on CV- Doplet (Triplex) on CV D Gransdades).
  Doppler Simultonovin CV-Depler, B/C/PV Doppler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler or CW ( Doppler, Simultaneous Color Doppler or Power Doppler .

21

SONIX User Manual

Appendix C: Transdcuer Specifications

Norma M. Witz

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

31

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
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	N	N	N	N	N	N	N	N[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

Notes:

• Abdominal organs and vascular 1
• 2 Breast, Thyrold, Testicle
• 3 Elastography
• Panoramic Imaging 4
• Compound Imaging 5
• Freehand 3D Imaging ହ
• 7 Live 3D/4D Imaging
• 8 Imaging for guldance of biopsy
• சி 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, RPW Dopler of CV Dopler, Br(GM.Doppler (Triplex) or CW Dopler (Triplex CW), BPower Doppler/PW Dopler or CW
  Dopler Sleudigagen Geler Dopler, B/C/PW Doppler (Tr Doppler, Simultaneous Color Doppler or Power Doppler

Appendlx C: Transdcuer Specifications

22

SONIX User Manual

(Division Sign-Off)

Division of Reproductive, Abdomin and Radiological Devic 510(k) Number

32

TEM10-7/5 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
Modes2	Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	N	N	N	N	N	N	N	N[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

Notes:

• 1 Abdominal organs and vascular
• Breast, Thyrold, Testicle 2
• Elastography 3
• 4 Panoramic Imaging
• 5 Compound Imaging
• Freehand 3D Imaging 6
• Llve 3D/4D Imaging 7
• Imaging for guidance of biopsy 8
• 9 lmaging 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
• BIM, BIPW Doppler or CW Doppler (Triplex) or CW Doppler (Triplex CW), BiPower Doppler/PW Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler

23

SONIX User Manual

Appendix C: Transdcuer Specifications

Tony M. West

Division on of Reproductive, Abdominal, and Radiological 5100k) Number

33

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	N	N	N	N	N	N	N	N[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

Notes:

• 1 Abdominal organs and vascular
  2 Breast, Thyroid, Testicle

• ઉ Elastography

• Panoramic Imaging 4

• 5 Compound Imaging

• 6 Freehand 3D Imaging

• Live 3D/4D Imaging 7

• 8 lmaging 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 (avallable only with the GPS transducer).

• B/M, B/PW Doppler or CW Dopler, B/C/PW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Dopler or CW
  Doppler, Simultaneous Color Doppler or Power Dopler 12

24

Appendix C: Transdcuer Specifications

SONIX User Manual

Aorned M. Wha

(Division Division of Reproductive, Abdominal, and Radiological D 510(k) Number

34

IOT9-5/40 Convex Intraoperational 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
Modes2	Other
[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[6,7] N[3-5,8]
Abdominal	P	P	P		P	P	P	P[6,7] N[3-5,8]
Intraoperative1	P	P	P		P	P	P	P[6,7] N[3-5,8]
Intraoperative Neurological	P	P	P		P	P	P	P[6,7] N[3-5,8]
Pediatric	P	P	P		P	P	P	P[6,7] N[3-5,8]
Small Organ2	P	P	P		P	P	P	P[6,7] N[3-5,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P		P	P	P	P[6,7] N[3-5,8]
Transvaginal	P	P	P		P	P	P	P[6,7] N[3-5,8]
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[6,7] N[3-5,8]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[6,7] N[3-5,8]
MSK Superficial	P	P	P		P	P	P	P[6,7] N[3-5,8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K061827

Notes:

• 1 Abdominal organs and vascular
  Breast, Thyroid, Testicle 2

• 3 Elastography

• प Panoramic Imaging

• ર Compound Imaging

• ნ Freehand 3D Imaging

• 7 Live 3D/4D Imaging

• 8 Imaging for guidance of biopsy

• 9 Imaging for guldance 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 PM, BPW Dopler or CW Dopler, BV Qualice only with in Gr S Ballsucer).
BM, BPW Dopler or CW Dopler, BKCPW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Dopler or CW Doppler, Simultaneous Color Doppler or Power Doppler

25

SONIX User Manual

Prescription Use Only

Aosain Whz
(Division Sign-Off)

Appendix C: Transdcuer Specifications

Division of Reproductive, Abdomin and Radiological I 510(k) Number