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.

AI/ML Overview

I am sorry, but the provided text does not contain specific acceptance criteria, study details, or performance metrics for the Sonix Ultrasound Scanner as you requested. The document is primarily a 510(k) summary for premarket notification, focusing on:

Device Description: General features and function of the ultrasound system and its accessories.
Intended Uses: A broad list of clinical applications for the system and various transducers.
Comparison to Predicate Devices: Establishing substantial equivalence based on intended use, principles of operation, and technological characteristics.
Safety Considerations: Compliance with general safety standards and acoustic output limits.
Transducer Specifications: Detailed tables outlining the modes of operation and new/previously cleared indications for each transducer.

There is no mention of:

Specific acceptance criteria (numerical thresholds for performance).
Any particular study (e.g., clinical trial, bench study with performance data) to prove device meets acceptance criteria.
Sample sizes used for test sets or training sets.
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications to establish ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
Standalone algorithm performance.
Type of ground truth used (e.g., pathology, outcomes data).
How ground truth was established for the training set.

The document highlights the device's compliance with general safety and acoustic output standards, but these are not presented as performance acceptance criteria in the context of clinical efficacy or diagnostic accuracy.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

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) chas.yu@ultrasonix.com

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

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, MedicalElectrical Equipment
C22-2 No 601.1	Canadian Standards Association, MedicalElectrical Equipment
EN 60601-1-2	European Norm, Collateral Standard,Electromagnetic Compatibility
IEC 60601-2-37	Particular requirements for the safety ofultrasonic medical diagnostic equipment
AIUM AOL	Acoustic Output Labeling Standard for DiagnosticUltrasound Equipment
AIUM RTD	Standard for Real-Time Display of Thermal andMechanical Acoustic Output Indices

3.0 Summary of Intended Uses

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)

Page 10 of 37

{4}------------------------------------------------

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)

{5}------------------------------------------------

The limits are the same as predicate Track 3 devices.

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September 2017 11:40 PM IST 10:

Page 12 of 37

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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.

{8}------------------------------------------------

Page 3 - Mr. Mark Job

If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at (301) 796-6542.

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

{10}------------------------------------------------

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

(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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
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

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
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
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, 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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	Combined12Modes	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes¹²	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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 .

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes2	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	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

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	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes2	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

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

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.