SONIX ULTRASOUND SCANNER

• K Number: K112726
• Device Name: SONIX ULTRASOUND SCANNER
• Manufacturer: UltraSonix Medical Corporation
• Date Cleared: 2011-09-27 ( 7 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K093462
• Predicate For: N/A

Intended Use

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

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

Device Description

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

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

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

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

AI/ML Overview

The provided text is a 510(k) summary for the Sonix Ultrasound Scanner, specifically detailing the addition of two new transducers. It outlines general information about the device, its intended use, and a comparison to predicate devices, focusing on technological characteristics and safety considerations. Crucially, this document does not contain any information about a study proving the device meets acceptance criteria for clinical performance metrics (e.g., accuracy, sensitivity, specificity) of an AI algorithm.

The information provided is primarily for regulatory clearance based on substantial equivalence to existing devices, meaning it demonstrates that the new transducers on the Sonix Ultrasound Scanner perform as safely and effectively as other legally marketed devices with the same intended use. This typically involves performance bench testing, electrical safety, and biocompatibility, but not clinical performance studies for an AI component in the way you've described.

However, I can extract information related to safety and technical specifications, which are a form of acceptance criteria for regulatory bodies.

Here's a breakdown of what can be extracted or inferred based on the prompt's requirements, and what cannot be found in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are related to acoustic output limits and compliance with safety standards, rather than clinical performance metrics like accuracy, sensitivity, or specificity, as there is no AI algorithm being evaluated in a clinical context in this document.

Acceptance Criteria (Acoustic Output Limits)	Reported Device Performance
ISPTA (d) ≤ 720mW/cm²	720mW/cm²
TIS/TIB/TIC (Range)	0.1-6.0 (Range)
Mechanical Index (MI) ≤ 1.9	1.9 (Maximum)
ISPPA (d) (Range)	0 - 700W/cm² (Range)
Compliance with IEC 601-1 (1988)	Complies
Compliance with IEC 60601-2-37	Complies
Compliance with AIUM AOL	Complies
Compliance with AIUM RTD	Complies

Note: The document specifies that these limits are the same as predicate Track 3 devices, implying that the device performs within these established safe ranges.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be determined from the provided text. The document describes a regulatory submission for device clearance, not a clinical performance study involving a test set of data or patient images for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be determined from the provided text. This information would be relevant for a clinical study evaluating an AI algorithm, which is not present in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be determined from the provided text. This information is pertinent to clinical studies with expert reviewers, not for a device's regulatory clearance based on substantial equivalence and safety standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. A MRMC study was not done. The document does not describe the evaluation of an AI algorithm or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The document describes an ultrasound scanner and its transducers, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be determined from the provided text. Ground truth is relevant for evaluating the performance of an AI model against a known correct answer, which is not the subject of this document. The "ground truth" in this context would be the physical measurements of acoustic output and compliance with electrical safety standards.

8. The sample size for the training set

Cannot be determined from the provided text. This information is relevant for AI model development, which is not discussed.

9. How the ground truth for the training set was established

Cannot be determined from the provided text. This information is relevant for AI model development, which is not discussed.

---

In summary: The provided 510(k) summary focuses on demonstrating that the Sonix Ultrasound Scanner, with its new transducers, is substantially equivalent to previously cleared devices in terms of technology, intended use, and safety. It details compliance with acoustic output limits and international safety standards, which serve as "acceptance criteria" for the device's safe operation. However, it does not include any studies or data related to the clinical performance of an AI algorithm, a test set, expert adjudication, or training data for an AI model.

Summary

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510 (k) Summary for the Sonix Ultrasound Scanner

K112726

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

1.0 Submitter Information

1.1 Submitter

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

1.2 Contact

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

1.3 Date Prepared

August 26, 2011

2.0 Device Name

2.1 Common Name

Ultrasound Imaging System

2.2 Proprietary Name

Sonix Ultrasound Scanner

2.3 Classification Name

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

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2.4 Classification

Class II

2.5 Predicate Device:

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

2.6 Reason for submission:

Clearance request for:

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

• m4DC7-3/40 .
• . L40-8/12

Note:

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

Name change request

N/A

New product clearance for:

N/A

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2.7 Device description

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

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

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

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

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

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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

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

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

4.0 Comparison to Predicate Device

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

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

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

Sonix Ultrasound Scanner (K093462)

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

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5.0 Technological characteristics

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

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

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

6.0 Safety considerations

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

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

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

The devices' acoustic output limits are:

ISPTA (d)	720mW/cm²
TIS/TIB/TIC	0.1-6.0 (Range)
Mechanical Index (MI)	1.9 (Maximum)
ISPPA (d)	0 - 700W/cm² (Range)

The limits are the same as predicate Track 3 devices.

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

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

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

SEP 2 7 2011

Re: K112726

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

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Transducer Model Number

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

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

{7}------------------------------------------------

CFR Part 803), please go to

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

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

Sincerely Yours,

Mary S. Redill

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

Enclosure(s)

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Indications for Use Form

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

Device Name: Sonix Ultrasound Scanner

Indications for Use:

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

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

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

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

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

Mary S. Patil
Division Sign off

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

510(k) K112726

। Page 1 of

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1

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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:

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic	P	P	P	P	P	P	P	P[3-6,8]
Fetal	P	P	P	P	P	P	P	P[3-8,11]
Abdominal	P	P	P	P	P	P	P	P[3-8,11]
Intraoperative1	P	P	P	P	P	P	P	P[3-8]
Intraoperative Neurological	P	P	P	P	P	P	P	P[3-8]
Pediatric	P	P	P	P	P	P	P	P[3-6,8,11]
Small Organ2	P	P	P	P	P	P	P	P[3-8,11]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8,11]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8,11]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal	P	P	P	P	P	P	P	P[3-6,8]
Transrectal	P	P	P	P	P	P	P	P[3-8,11]
Transvaginal	P	P	P	P	P	P	P	P[3-8,11]
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular	P	P	P	P	P	P	P	P[3-8,11]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-8,11]
MSK Superficial	P	P	P	P	P	P	P	P[3-8,11]
Vascular Access	P	P	P	P	P	P	P	P[3-8,10,11]
Nerve Block	P	P	P	P	P	P	P	P[3-9,11]
Other

N = New indication; P = Previously cleared under K093462

Notes :

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

1

Prescription Use Only

Mary S. Postel

---

(Division Sign-Off)

510K

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

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SA4-2/24 Phased Array Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative¹
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ²
Neonatal Cephalic	P	P	P		P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

Appendix C: Transdcuer Specifications

Prescription Use Only

2

Mary Pastel
(Division Sign-Off)

SONIX User Manual

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

510K K112726

{11}------------------------------------------------

SA3-1/24 Phased Array Transducer

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

Clinical Application	Mode of Operation								Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

SONIX User Manual

3

Appendix C: Transdcuer Specifications

Prescription Use Only

Mary S. Patel

---

(Division Sign Off)

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

510K K112706

{12}------------------------------------------------

PA4-2/20 Phased Array Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative¹
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ²
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

す

Appendix C: Transdcuer Specifications

Prescription Use Only

(Division Sign-Off)

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

510K KILAUAC

SONIX User Manual

{13}------------------------------------------------

PA7-4 Phased Array Transducer

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

Clinical Application	Mode of Operation							Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2
Neonatal Cephalic	P	P	P		P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac	P	P	P	P	P	P	P	P[3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

SONIX User Manual

5

Appendix C: Transdcuer Specifications

Mary Pastel

(Division Sign On)

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

510K K112726

{14}------------------------------------------------

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

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

Clinical Application	Mode of Operation							Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-6,8,11]
Abdominal	P	P	P		P	P	P	P[3-6,8,11]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-6,8,11]
Small Organ2	P	P	P		P	P	P	P[3-6,8,11]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[3-6,8,11]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-6,8,11]
MSK Superficial	P	P	P		P	P	P	P[3-6,8,11]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

Appendix C: Transdcuer Specifications

Prescription Use Only

Mary S. Patil

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

510K Kบลาวช

SONIX User Manual

6

{15}------------------------------------------------

C5-2/40 Convex Transducer

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

Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-6,8]
Abdominal	P	P	P		P	P	P	P[3-6,8]
Intraoperative¹
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-6,8]
Small Organ²	P	P	P		P	P	P	P[3-6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-6,8]
MSK Superficial	P	P	P		P	P	P	P[3-6,8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes :

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

SONIX User Manual

7

Appendix C: Transdcuer Specifications

Man S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In

510K KULAC

{16}------------------------------------------------

C7-3/50 Convex Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-6,8]
Abdominal	P	P	P		P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-6,8]
Small Organ2	P	P	P		P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P		P	P	P	P[3-6,8]
Adult Cephalic	P	P	P		P	P	P	P[3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-6,8]
MSK Superficial	P	P	P		P	P	P	P[3-6,8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

8

Appendix C: Transdcuer Specifications

Mary S. Roth
(Division Sign-Off)

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

510K K112726

SONIX User Manual

{17}------------------------------------------------

MC9-4/12 Microconvex Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P[3-6,8]
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2	P	P	P	P	P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular	P	P	P	P	P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-6,8]
MSK Superficial	P	P	P	P	P	P	P	P[3-6,8]
Vascular Access	P	P	P	P	P	P	P	P[3-6,8,10]
Nerve Block	P	P	P	P	P	P	P	P[3-6,8,9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

9

SONIX User Manual

Appendix C: Transdcuer Specifications

Mary S. Pastl

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

510K KII2A26

{18}------------------------------------------------

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

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

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

N = New indication; P = Previously cleared under K093462

Notes:

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

10

Appendix C: Transdcuer Specifications

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

510K. Kilana

SONIX User Manual

SONIX User Manual

{19}------------------------------------------------

L9-4/38 Linear Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P[3-6,8]
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2	P	P	P	P	P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P	P	P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-6,8]
MSK Superficial	P	P	P	P	P	P	P	P[3-6,8]
Vascular Access	P	P	P	P	P	P	P	P[3-6,8,10]
Nerve Block	P	P	P	P	P	P	P	P[3-6,8,9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

SONIX User Manual

Prescription Use Only

11

Appendix C: Transdcuer Specifications

Mary S. Pastel

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

510K K11272C

{20}------------------------------------------------

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

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other(Notes)
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-6,8,11]
Abdominal	P	P	P		P	P	P	P[3-6,8,11]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-6,8,11]
Small Organ2	P	P	P		P	P	P	P[3-6,8,11]
Neonatal Cephalic	P	P	P		P	P	P	P[3-6,8,11]
Adult Cephalic	P	P	P		P	P	P	P[3-6,8,11]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[3-6,8,11]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-6,8,11]
MSK Superficial	P	P	P		P	P	P	P[3-6,8,11]
Vascular Access	P	P	P		P	P	P	P[3-6,8,10,11]
Nerve Block	P	P	P		P	P	P	P[3-6,8,9,11]
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

12

Appendix C: Transdcuer Specifications

Prescription Use Only

Mary S. Patel
(Division Sign-Off)

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

510K. Kucnac

SONIX User Manual

{21}------------------------------------------------

L14-5W/60 Wide Linear Transducer

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

Clinical Application	Mode of Operation							Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
Ophthalmic
Fetal	P	P	P	P	P	P	P	P[3-6,8]
Abdominal	P	P	P	P	P	P	P	P[3-6,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2	P	P	P	P	P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P	P	P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-6,8]
MSK Superficial	P	P	P	P	P	P	P	P[3-6,8]
Vascular Access	P	P	P	P	P	P	P	P[3-6,8,10]
Nerve Block	P	P	P	P	P	P	P	P[3-6,8,9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

13

SONIX User Manual

Appendix C: Transdcuer Specifications

Mury S. Patil
(Division Sign-Off)

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

510K K112726

{22}------------------------------------------------

L15-8/26 Linear Transducer

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

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

N = New indication; P = Previously cleared under K093462

Notes :

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

Appendix C: Transdcuer Specifications

Prescription Use Only

14

Mary S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic D

510K K112726

SONIX User Manual

{23}------------------------------------------------

BPL9-5/55 Linear Endocavity Biplane Transducer

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

	Mode of Operation
Clinical Application	B	M	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	P[3-6,8]
Transvaginal	P	P	P	P	P	P	P	P[3-6,8]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

SONIX User Manual

15

Appendix C: Transdcuer Specifications

Mary S. Patil

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

510K K112726

{24}------------------------------------------------

BPC8-4/10 Microconvex Endocavity Biplane Transducer

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

Clinical Application	Mode of Operation
	B	M	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	P[3-6,8]
Transvaginal	P	P	P	P	P	P	P	P[3-6,8]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

Appendix C: Transdcuer Specifications

Prescription Use Only

16

Mary S. Patil

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

510K Kuาว6

SONIX User Manual

{25}------------------------------------------------

HST15-8/20 Linear Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic	P	P	P	P	P	P	P	P[3-6,8]
Fetal	P	P	P	P	P	P	P	P[3-6,8]
Abdominal
Intraoperative1
Intraoperative Neurological	P	P	P	P	P	P	P	P[3-6,8]
Pediatric	P	P	P	P	P	P	P	P[3-6,8]
Small Organ2	P	P	P	P	P	P	P	P[3-6,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P[3-6,8]
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial	P	P	P	P	P	P	P	P[3-6,8]
Peripheral Vascular	P	P	P	P	P	P	P	P[3-6,8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-6,8]
MSK Superficial	P	P	P	P	P	P	P	P[3-6,8]
Vascular Access	P	P	P	P	P	P	P	P[3-6,8,10]
Nerve Block	P	P	P	P	P	P	P	P[3-6,8,9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

SONIX User Manual

Prescription Use Only

17

Mary S. Patel
(Division Sign-Off)

Appendix C: Transdcuer Specifications

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

510K K112726

{26}------------------------------------------------

4DC7-3/40 Motorized Convex Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-8]
Abdominal	P	P	P		P	P	P	P[3-8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-8]
Small Organ2	P	P	P		P	P	P	P[3-8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	P	P		P	P	P	P[3-8]
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-8]
MSK Superficial	P	P	P		P	P	P	P[3-8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

Appendix C: Transdcuer Specifications

Prescription Use Only

18

Mary S Patil
(Division Sign-Off)

Division of Radiological Office of In Vitro Diagno

SONIX User Manual

510K K12226

{27}------------------------------------------------

4DL14-5/38 Motorized Linear Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	Combined12Modes	Other[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P[3-8]
Abdominal	P	P	P		P	P	P	P[3-8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P[3-8]
Small Organ2	P	P	P		P	P	P	P[3-8]
Neonatal Cephalic	P	P	P		P	P	P	P[3-8]
Adult Cephalic	P	P	P		P	P	P	P[3-8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional	P	P	P		P	P	P	P[3-8]
MSK Superficial	P	P	P		P	P	P	P[3-8]
Vascular Access	P	P	P		P	P	P	P[3-8,10]
Nerve Block	P	P	P		P	P	P	P[3-9]
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

19

SONIX User Manual

Prescription Use Only

Mary S Pastel
(Division Sign-Off)

Appendix C: Transdcuer Specifications

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

510K B112726

{28}------------------------------------------------

4DEC9-5/10 Motorized Microconvex Endocavity Transducer

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

Clinical Application	Mode of Operation								Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes2
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	P	P[3-8]
Transvaginal	P	P	P	P	P	P	P	P[3-8]
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

Appendix C: Transdcuer Specifications

Prescription Use Only

20

SONIX User Manual

Mary S. Patel
(Division Sign-Off)

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

510K B112726

{29}------------------------------------------------

T7-4 Transesophageal Phased Array Transducer

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

	Mode of Operation
Clinical Application	B	M	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	P	P	P	P	P[3-6,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

SONIX User Manual

Prescription Use Only

21

Mary S. Padell

Appendix C: Transdcuer Specifications

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

510K Kuวา26

{30}------------------------------------------------

TEM7-3/9 Transesophageal Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notas]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	P	P	P	P	P[3-6,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

22

Appendix C: Transdcuer Specifications

Prescription Use Only

Mary S. Padilla
Division Sign Off

Pinsion of Bladiological ce of In Vitro Diago and Selety

K112726

SONIX User Manual

11

",一个

{31}------------------------------------------------

mTEE8-3/5 Transesophageal Transducer

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

Clinical Application	Mode of Operation
	B	M	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	P	P	P	P	P[3-6,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

SONIX User Manual

23

Appendix C: Transdcuer Specifications

Mary S. Patil
(Division Sign Off)

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

510K K112726

{32}------------------------------------------------

TEEIMA Transesophageal Transducer

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

Clinical Application	Mode of Operation
	B	M	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	P	P	P	P	P[3-6,8]
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

Appendix C: Transdcuer Specifications

Prescription Use Only

24

SONIX User Manual

Mary Stattl
(Division Sign Off)

Pivision of Radio

K112726

{33}------------------------------------------------

IOT9-5/40 Convex Intraoperational Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P[3-8]
Abdominal	P	P	P	P	P	P	P	P[3-8]
Intraoperative1	P	P	P	P	P	P	P	P[3-8]
Intraoperative Neurological	P	P	P	P	P	P	P	P[3-8]
Pediatric	P	P	P	P	P	P	P	P[3-8]
Small Organ2	P	P	P	P	P	P	P	P[3-8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	P	P[3-8]
Transvaginal	P	P	P	P	P	P	P	P[3-8]]
Transurethral
Transcranial
Peripheral Vascular	P	P	P	P	P	P	P	P[3-8]
Laparoscopic
MSK Conventional	P	P	P	P	P	P	P	P[3-8]
MSK Superficial	P	P	P	P	P	P	P	P[3-8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared under K093462

Notes:

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

SONIX User Manual

Prescription Use Only

25

Mary S Pastel
(Division Sign-Off)

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

Appendix C: Transdcuer Specifications

510K K112726

{34}------------------------------------------------

m4DC7-3/40 Motorized Convex Transducer

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

Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	N	N	N	N	N	N	N	N[3-8]
Abdominal	N	N	N	N	N	N	N	N[3-8]
Intraoperative1
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N	N[3-8]
Small Organ2	N	N	N	N	N	N	N	N[3-8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional	N	N	N	N	N	N	N	N[3-8]
MSK Superficial	N	N	N	N	N	N	N	N[3-8]
Vascular Access
Nerve Block
Other

N = New indication; P = Previously cleared

Notes:

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

Appendix C: Transdcuer Specifications

Prescription Use Only

26

SONIX User Manual

(Disision Sign-Off

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

510K Kuara26

{35}------------------------------------------------

L40-8/12 Linear Transducer

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

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological	N	N	N		N	N	N	N[3-6,8]
Pediatric	N	N	N		N	N	N	N[3-6,8]
Small Organ2	N	N	N		N	N	N	N[3-6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	N	N	N		N	N	N	N[3-6,8]
Laparoscopic
MSK Conventional	N	N	N		N	N	N	N[3-6,8]
MSK Superficial	N	N	N		N	N	N	N[3-6,8]
Vascular Access	N	N	N		N	N	N	N[3-6,8,10]
Nerve Block	N	N	N		N	N	N	N[3-6,8,9]
Other

N = New indication; P = Previously cleared

Notes:

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

SONIX User Manual

27

Prescription Use Only

May S. Patil
(Division Sign-Off)

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

Appendix C: Transdcuer Specifications

510K. K112726

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.