SONIXTABLET ULTRASOUND SCANNER

• K Number: K113663
• Device Name: SONIXTABLET ULTRASOUND SCANNER
• Manufacturer: UltraSonix Medical Corporation
• Date Cleared: 2012-01-25 ( 43 days)
• Product Code: IYN
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K102997
• Predicate For: K123001

Intended Use

The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, 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 SonixTABLET 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 optional electrocardiography (ECG) display feature and support for a 3lead 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 SonixTABLET 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

Here's a breakdown of the acceptance criteria and study information for the SonixTABLET Ultrasound Scanner, based on the provided document:

The document is a 510(k) Summary for the SonixTABLET Ultrasound Scanner, focusing on the addition of two new transducers (m4DC7-3/40 and L40-8/12) to a previously cleared device. As such, the "acceptance criteria" discussed are largely related to substantial equivalence to predicate devices and compliance with relevant safety and performance standards for ultrasound systems, rather than specific performance metrics for a novel AI device feature. The document does not describe a study involving human readers or AI assistance in the context of diagnostic performance. Instead, it focuses on the device's adherence to regulatory standards and its intended use.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be fully answered as they pertain to a type of study not detailed in this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an ultrasound system, the acceptance criteria are generally based on compliance with recognized standards and substantial equivalence to predicate devices, particularly regarding safety and fundamental performance. Specific performance metrics like sensitivity/specificity for a diagnostic task are not detailed for the overall ultrasound system in this type of submission unless a new diagnostic claim is being made.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Substantial Equivalence	Device is substantially equivalent to predicate devices with respect to intended use/indications for use, principles of operation, and technological characteristics.	The SonixTABLET Ultrasound Scanner is described as "substantially similar to that of the predicates," with similar digital beamformer, backend processing, modes of operation (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler, Continuous Wave Doppler), and image quality adjustment parameters.
Safety - Acoustic Output	Compliance with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (2004)" (UD-3) and the guideline limits set in the September 9, 2008 revision of 510(k) Diagnostic Ultrasound Guidance.	The device complies with these standards. The acoustic output limits are reported as: - ISPTA(d): 720mW/cm2 - TIS/TIB/TIC: 0.1 - 6.0 (Range) - Mechanical Index (MI): 1.9 (Maximum) - ISPPA(d): 0 - 700W/cm2 (Range) These limits are stated to be "the same as predicate Track 3 devices."
Safety - Electrical	Compliance with IEC 60601-1 (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 system is designed to comply with these standards.
Biocompatibility	Transducer patient contact materials must be biocompatible.	"Transducer patient contact materials are biocompatible."
Intended Use	The intended uses for the added transducers (m4DC7-3/40 and L40-8/12) must align with general diagnostic ultrasound applications and modes of operation as previously cleared or as new, appropriate indications.	The document lists specific clinical applications and modes for the new transducers (marked with "N" for New indication and "P" for Previously cleared under K102997), covering various anatomical regions and imaging modalities (B-mode, M-mode, PW Doppler, Color Doppler, Power Doppler, Combined modes, and notes for features like Elastography, 3D imaging, biopsy guidance).

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Detailed breakdown of specific questions:

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

• Not applicable / Not provided. This document is a 510(k) summary for an ultrasound system seeking clearance for new transducers. It does not contain information about a test set or data provenance for a diagnostic performance study in the way a submission for an AI/CADe device would. The "study" here is primarily a demonstration of compliance with engineering standards and substantial equivalence to predicate devices, which typically doesn't involve clinical "test sets" in this context.

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)

• Not applicable / Not provided. As above, no diagnostic performance study with a distinct "test set" and "ground truth" established by experts is described for the purpose of demonstrating the device's diagnostic accuracy. The safety and performance are assessed against technical standards and comparison to predicate devices, not through a clinical accuracy study with expert ground truth.

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

• Not applicable / Not provided. No clinical diagnostic performance study requiring an "adjudication method" for a test set is detailed in this 510(k) summary.

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 comparative effectiveness study was not done. The document describes a traditional ultrasound imaging system with added transducers, not an AI or AI-assisted diagnostic device. Therefore, there's no mention of human readers improving with or without AI assistance.

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

• No, this is not applicable. The SonixTABLET Ultrasound Scanner is a hardware and software system for real-time ultrasound imaging used by a human operator, not a standalone algorithm.

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

• Not applicable / Not provided. No diagnostic performance study with an explicit "ground truth" for evaluating diagnostic accuracy is presented in this 510(k) summary. The "ground truth" in this context would be the underlying physical principles of ultrasound imaging and engineering specifications, and comparison to images produced by predicate devices, rather than clinical outcomes or pathology for specific diagnoses.

8. The sample size for the training set

• Not applicable / Not provided. This is an ultrasound imaging system, not an AI model that requires a training set.

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

• Not applicable / Not provided. As in 8, this is not an AI model.

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In summary, the provided document is a regulatory submission demonstrating the safety and substantial equivalence of an ultrasound device and its transducers to existing devices and standards. It does not contain the kind of clinical study details (test sets, expert ground truth, AI performance metrics, etc.) that would be found in a submission for a novel AI/CADe diagnostic device.

Summary

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510 (k) Summary for the SonixTABLET Ultrasound Scanner

JAN 2 5 2012

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 2009 revision 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

SonixTABLET 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:

SonixTABLET Ultrasound Scanner (K102997) Predicate transducer for m4DC7-3/40: 4DC7-3/40 cleared under K102997 Predicate transducer for L40-8/12: L14-5/38 and HST15-8/20, both are cleared under K102997

2.6 Reason for submission:

Clearance request for:

Addition of the following two transducers to SonixTABLET Ultrasound Scanner which was previously cleared under K102997.

• . m4DC7-3/40
• L40-8/12 .

Note:

Indications for use and modes of operation of the SonixTABLET Ultrasound Scanner previously cleared under K102997 are unchanged.

Name change request

N/A

New product clearance for:

N/A

2.7 Device description

The SonixTABLET 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.

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The system has an optional electrocardiography (ECG) display feature and support for a 3lead 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 SonixTABLET Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

Frequency Range	2-40MHz
Transducer types	Linear array
	Curved array
	TEE array
	Intracavity array
	Phased array

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

ReferenceNumber	Title	FDA RecognitionNumber
IEC 60601-1	IEC 60601-1, Medical Electrical Equipment - Part 1: GeneralRequirements for Safety, 1988: Amendment 1, 1991-11.Amendment 2, 1995.	5-4
IEC 60601-1-2	IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral standard: ElectromagneticCompatibility - Requirements and Tests (Edition 2:2001 withAmendment 1:2004; Edition 2.1 (Edition 2:2001 consolidatedwith Amendment 1:2004)).	5-34
IEC 60601-2-37	IEC 60601-2-37 (2004) (2005) Amendment 2, Medical electricalequipment - Part 2-37: Particular requirements for the basicsafety and essential performance of ultrasonic medicaldiagnostic and monitoring equipment.	12-198
AIUM AOL	Acoustic Output Labeling Standard for Diagnostic UltrasoundEquipment Revision 1 - A standard for How ManufacturersShould Specify Acoustic Output Data	12-193
AIUM RTD1-2004	Standard for Real - Time Display of Thermal and MechanicalAcoustic Output Indices on Diagnostic Ultrasound EquipmentRevision 1	12-140

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3.0 Summary of Intended Uses

The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, 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 SonixTABLET 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 SonixTABLET 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.

SonixTABLET Ultrasound Scanner (K102997) Predicate transducer for m4DC7-3/40: 4DC7-3/40 cleared under K102997 Predicate transducer for L40-8/12: L14-5/38 and HST15-8/20, both are cleared under K102997

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.

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6.0 Safety considerations

As track 3 ultrasound device, the SonixTABLET 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 SonixTABLET Ultrasound Scanner complies with the guideline limits set in the September 9, 2008 revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the SonixTABLET Ultrasound Scanner is designed to comply with IEC 60601-1 (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 & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three overlapping profiles suggesting movement or layers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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

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

JAN 2 5 2012

Re: K113663

Trade/Device Name: SonixTABLET Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: January 9, 2012 Received: January 10, 2012

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 DUS 6000 Digital Ultrasonic Imaging System, as described in your premarket notification:

Transducer Model Number

4DC7-3/40 Motorized Convex Radius 4DEC9-5/10 Motorized Microconvex Endocavity Radius 4DL14-5/38 Motorized Linear BPL9-5/55 Linear Endocavity Biplane BPC8-4/10 Microconvex Endocavity Biplane C5-2/60 and C5-2/60 GPS Convex C7-3/50 Convex MC9-4/12 Microconvex EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity Radius HST15-8/20 Linear L9-4/38 Linear

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L14-5/38 and L14-5/38 GPS Linear L14-5W/60 Wide Linear PA7-4/12 Phased Array SA4-2/24 Phased Array mTEE8-3/5 Transesophageal Phased Array Radius m4DC7-3/40otorized Micro Convex Radius 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/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.

If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns, Ph.D. at [phone].

Sincerely Yours,

Mary S Pastel

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): K113663

Device Name: SonixTABLET Ultrasound Scanner

Indications for Use:

The SonixTABLET Ultrasound Scanner is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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. Pastel

510K. K113663

Page 1 of _1

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diagnostic ultrasound indications for use form

SONIXTABLET ULTRASOUND SCANNER

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

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

N = New indication; P = Previously cleared under K102997

Notes:

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle 2.
• Elastography రా
• 4. Panoramic Imaging
• Compound Imaging ട.
• Freehand 3D Imaging e.
• Live 3D/4D Imaging 7.
• Imaging for guidance of biopsy 8.
• Imaging for guidance of nerve block injections ക്
• 10. Imaging for guidance of central or peripheral lines
• 10. Imaging to goldarce or chiralines

11. Volume Navigation/SontsGots'SorisCles (avaiable only with the GPS transluces)
12. BM, BPW Dopler or CW Dopler (Triplex) or Simultaneous Color Doppler or Power Dopplar.

Mary Pastel

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

510K. K113663

Prescription Use Only

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4DC7-3/40 Motorized Convex Radius Transducer

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes 12	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
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

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

N = New indication; P = Previously cleared under K102997

Notes:

1. Abdominal organs and vascular

• Breast, Thyroid, Testicle 2.
• 3. Elastography
• Panoramic Imaging ব :
• ട. Compound Imaging
• 6. Freehand 3D Imaging
• 7. Live 3D/4D Imaging
• Imaging for guidance of biopsy 8.
• റ്റ. Imaging for guidance of nerve block injections

10. Imaging for guidance of central or peripheral lines

• 11. Mulune Navigation/image Fusions/sers/ (available only with the GPS transluces)

12. BM, BJPW Oopler or CV Dopler (Triplex) or CW Dopler (Triplex CW), BPower Simultaneous Color Doppler or Power Doppler.

Mary Postel
(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety 510k

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4DEC9-5/10 Motorized Microconvex Endocavity Radius Transducer

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

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

N = New indication; P = Previously cleared under K102997

Notes:

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle 2.
• Elastography റ്റ്
• 4. Panoramic Imaging
• 5. Compound Imaging
• Freehand 3D Imaging 6.
• Live 3D/4D Imaging 7.
• Imaging for guidance of biopsy 8.
• 9. Imaging for guidance of nerve block injections
• 10. Imaging for guidance of central or peripheral lines
• 11 Meangler of Januarian (Teles) (available only with the GPS transducer)

11. Volume Navigationimage Fusion(Sonix(Triplex) or CW Dopler (Triplex CW), BPower Doppler or C Simultaneous Color Doppler or Power Doppler.

510

Mary S Padelf
(Division Sign-Off)

Office of In Vitro Diagnostic Device Evaluation and Safety

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4DL14-5/38 Motorized Linear Transducer

Clinical Application	Mode of Operation							Other [Notes]
	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	Combined Modes12
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	P [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
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

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

N = New indication; P = Previously cleared under K102997

Notes:

• Abdominal organs and vascular 1.
• Breast, Thyroid, Testicle 2.
• Elastography છં.
• Panoramic Imaging ধ .
• ട. Compound Imaging
• 6. Freehand 3D Imaging
• Live 3D/4D Imaging 7.
• Imaging for guidance of biopsy 8.
• Imaging for guidance of nerve block injections 9.
• 10. Imaging for guidance of central or peripheral lines
• 10. Inflaging in Linka of Leineral Mos

11. Volume Navigation/SonxGPS" (available only with the GPS transduce)
12. BM, BPW Oopler, BC/PW Dopler (Triplex) or CW Dopler Simultaneous Color Doppler or Power Doppler.

4

Mary S. Patel
(Division Sign Off)

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

510K K113663

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

BPL9-5/55 Linear Endocavity Biplane Transducer

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
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

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

N = New indication; P = Previously cleared under K102997

• Abdominal organs and vascular 1.
• Breast, Thyroid, Testicle ip
• 3. Elastography
• 4. Panoramic Imaging
• Compound Imaging ક.
• Freehand 3D Imaging റ്.
• 7. Live 3D/4D Imaging
• Imaging for guidance of biopsy 8.
• Imaging for guidance of nerve block injections g.
• 10. Imaging for guidance of central or peripheral lines
• 11. Inading the drition deliver in least in east in and the GPS transducer)

11. BM. Blevigation on CW Dopler (Triplex) or CW Dopler (Triplex CW), BPower Dopler or CW Do Simultaneous Color Doppler or Power Doppler.

Mary S Patel
(Division Sign-Off)

Office of In nd Safety

510K K113663

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

BPC8-4/10 Microconvex Endocavity Biplane Transducer

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
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

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

N = New indication; P = Previously cleared under K102997

• Abdominal organs and vascular 1.
• Breast, Thyroid, Testicle 2.
• 3. Elastography
• 4. Panoramic Imaging
• Compound Imaging 5.
• Freehand 3D Imaging હં.
• 7. Live 3D/4D Imaging
• Imaging for guidance of biopsy 8.
• lmaging for guidance of nerve block injections റ്റ്.
• 10. Imaging for guidance of central or peripheral lines
• 10. Imaging to central or Dentral inis

11. Volune Variation (Sentral or Dellera) " (avalable only with the GPS transducer)
12. Blan, Blev Oopler, or CV Simultaneous Color Doppier or Power Doppler.

Mary S. Pastel
(Division Sign-Off)

Division of Radiol itro D agnostic Device Evaluation and Safety

Prescription Use Only

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

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P [3-6,8,11]
Abdominal	P	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	P [3-6,8,11]
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P [3-6,8,11]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular	P	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

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

N = New indication; P = Previously cleared under K102997

• t. Abdominal organs and vascular
• Breast, Thyroid, Testicle 2.
• Elastography 3.
• Panoramic Imaging ব :
• 5. Compound Imaging
• Freehand 3D Imaging 6.
• Live 3D/4D Imaging 7.
• 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/SonixGPS™ (available only with the GPS transducer)
• 12. B/M, B/PW Dopler or CW Dopler (Triplex) or CW Dopber (Triplex CW), B/Power Doppler/W Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler.

Bivision Sig

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

f In Vitro Diagnostic Device Evaluation and Sa
510K K113663

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

C7-3/50 Convex Transducer

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	P	P	P		P	P	P	P [3-6,8]
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

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

N = New indication; P = Previously cleared under K102997

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle 2.
• Elastography 3.
• 4. Panoramic Imaging
• 5. Compound Imaging
• 6. Freehand 3D Imaging
• 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/SonixGPS™ (available only with the GPS transducer)
• 12. BMM, BPW Doptier, ar CV Doppler (Triplex) or CW Dopler (Triplex CW), BPower Doppler/W Doppler or CW Dopler or CW Dopler, Simultaneous Color Doppler or Power Doppler.

Mary Patel
(Division Sign-Off)

Division of Radiclogical Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K

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

MC9-4/12 Microconvex Transducer

Clinical Application	Mode of Operation								Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12
Ophthalmic
Fetal
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	P	P	P		P	P	P	P [3-6,8]
Peripheral Vascular	P	P	P		P	P	P	P [3-6,8,10]
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]

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

N = New indication; P = Previously cleared under K102997

Notes:

• Abdominal organs and vascular 1.
• 2. Breast, Thyroid, Testicle
• Elastography 3.
• Panoramic Imaging 4.
• Compound Imaging ട്
• ട. Freehand 3D Imaging
• Live 3D/4D Imaging 7.
• Imaging for guidance of biopsy 8.
• Imaging for guidance of nerve block injections 9.

10. Imaging for guidance of central or peripheral lines

• 10. Imaging to guidanea manillea inies

11. Volune Navigation (Rentralianes) (Cityle Caralder)
12. BM, BPW Ogpler or CV Dopler (Triplex) or CW Dopler (Triplex CV), Simultaneous Color Doppler or Power Doppler.

510K

Mary Stastel
(Division Sign-Off)

Division of Rachological Devices Office of In Vitro Diagnostic Davica Evaluation and Safety

Prescription Use Only

.

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

EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity Radius Transducer

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 [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

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

N = New indication; P = Previously cleared under K102997

Notes:

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle in
• 3. Elastography
• Panoramic Imaging 4.
• Compound Imaging 5.
• Freehand 3D Imaging ર.
• 7. Live 3D/4D Imaging
• 8. Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections ക്
• 10. Imaging for guidance of central or peripheral lines
• 16. Imaging for galamos er contract portion SonixGPS™ (available only with the GPS transducer)
• 11. Volume Navgalonimage Frushionistic (avalable only will be Gr S ransadeer)

12. BM, BPW Dopler, BC/PW Dopler (Tiplex) or CW Dopler (Triplex CV), BPower Doppler/ BINI, Bir W Buppler or Power or Power Doppler.

રાજ્યન

---

Mary Patel

Office of In Evaluation and Sefety

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

HST15-8/20 Linear Transducer

Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal
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 [3-6,6]
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

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

N = New indication; P = Previously cleared under K102997

Notes:

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle 2.
• Elastography 3.
• 4. Panoramic Imaging
• ട. Compound Imaging
• Freehand 3D Imaging હ.
• 7. Live 3D/4D Imaging
• 8. Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections න්
• 10. Imaging for guidance of central or peripheral lines
• 10. Intellig on gotter of cancerines inco

11. Volume Navigationinage Fusions (FS)" (avaiable only with the GPS transluce)
12. BM, BPW Dopler, or CW Dopler (Triplex) Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

Mary S. Pastel
(Division Sign-Off)

Division of Reals logical Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K

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

diagnostic ultrasound indications for use form

L9-4/38 Linear Transducers

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	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	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

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

N = New indication; P = Previously cleared under K102997

Notes:

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle 2.
• Elastography 3.
• Panoramic Imaging ব :
• റ്. Compound Imaging
• 6. Freehand 3D Imaging
• Live 3D/4D Imaging 7.
• Imaging for guidance of biopsy 8.
• Imaging for guidance of nerve block injections g.
• 10. Imaging for guidance of central or peripheral lines
• 10. Inleging or enned of Enner F. Mos

11. Volume Navigation/SontsOns™ (available only with the GPS transbucer)
12. BM, BPW Dopler, or CV Dopler (Triplex) or CW Dopl Simultaneous Color Doppler or Power Doppler.

610K

Mary S Patel

division Sign-Off Division of Hactorological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

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

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P [3-6,8,11]
Abdominal	P	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

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

N = New indication; P = Previously cleared under K102997

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle 2.
• റ്റ് Elastography
• 4. Panoramic Imaging
• Compound Imaging ട.
• Freehand 3D Imaging 6.
• Live 3D/4D Imaging 7.
• 8. Imaging for guidance of biopsy
• Imaging for guidance of nerve block injections റ്റ്.

10. Imaging for guidance of central or peripheral lines

• 10. Imaging for guidance of central or peripheral lines

11. Volume Navigation/image Fusion/SonixGPS™ (available only with the GPS transducer)

• 11: Tolline Horgber or CW Dopler (Tiplex) or CW Dopler (Triplex CW), BPower Doppler PW Dopler or CW Dopler or CW Dopler or CW Dopler or CW Dopler or CW Dopler or CW Dopler or Simultaneous Color Doppler or Power Doppler.

Mary Pastel
(Division Sign-Off)

Division of Radiological Devices ostic Device Evaluation and Safety Office of In Vitrp

510K. K113663

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

L14-5W/60 Wide Linear Transducer

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
Ophthalmic
Fetal	P	P	P		P	P	P	P [3-8,8]
Abdominal	P	P	P		P	P	P	P [3-8,8]
Intraoperative1
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P [3-8,8]
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 [3-8,8]
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

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

N = New indication; P = Previously cleared under K102997

Notes:

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle સં
• 3. Elastography
• 4. Panoramic Imaging
• Compound Imaging 5.
• Freehand 3D Imaging રું.
• 7. Live 3D/4D Imaging
• Imaging for guidance of biopsy 8.
• Imaging for guidance of nerve block injections ு.

10. Imaging for guidance of central or peripheral lines

14

510K

Mary S. Postel
(Division Sign-Off)

Division of Office of In Vitro aluation and Safety Disamostic

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

PA7-4/12 Phased Array Transducer

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

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

N = New indication; P = Previously cleared under K102997

Notes:

• 1. Abdominal organs and vascular
• 2. Breast, Thyroid, Testicle
• Elastography 3.
• Panoramic Imaging 4.
• Compound Imaging ട്.
• Freehand 3D Imaging 6.
• Live 3D/4D Imaging 7.
• Imaging for guidance of biopsy 8.
• Imaging for guidance of nerve block injections 9.
• 10. Imaging for guidance of central or peripheral lines
• 10. Imaging to canara of papileal intes

11. Volume Navigation/Res" (avaiable only with the CPS transtucer)
12. BM, BPW Dopber or CV Dopber (Triplex) or CW Dopler Simultaneous Color Doppler or Power Doppler.

210K

Mary Stachel
(Division Sign-Off)

Division of Radiological Dovices Office of In Vitro Diagn flostic Device Evaluation and Safety

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

SA4-2/24 Phased Array Transducer

	Mode of Operation
Clinical Application	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

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

N = New indication; P = Previously cleared under K102997

• Abdominal organs and vascular 1.
• Breast, Thyroid, Testicle 2.
• Elastography స్
• 4. Panoramic Imaging
• Compound Imaging ഗ്
• Freehand 3D Imaging 6.
• Live 3D/4D Imaging 7.
• 8. Imaging for guidance of biopsy
• lmaging for guidance of nerve block injections ல்
• 10. Imaging for guidance of central or peripheral lines
• 10. Milang on gotter of caterial inco

11. Volume Navigation/image Fusionis(PS)" (avalable only with the GPS transducer)
12. BM, B/PW Dopler, or CV Dopler (Tiplex) o Simultaneous Color Doppler or Power Doppler.

Mary Patel

---

(Division Sign-Off)

Division of Had clogic il De vices Office of In Vitro Diagnostic Davide, Evaluation and Sefety 510K

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

mTEE8-3/5 Transesophageal Phased Array Radius Transducer

	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
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

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

N = New indication; P = Previously cleared under K102997

Notes:

• 1. Abdominal organs and vascular
• Breast, Thyroid, Testicle 2.
• Elastography 3.
• 4. Panoramic Imaging
• ട. Compound Imaging
• Freehand 3D Imaging 6.
• Live 3D/4D Imaging 7.
• Imaging for guidance of biopsy 8.
• 9. Imaging for guidance of nerve block injections
• 10. Imaging for guidance of central or peripheral lines

510K 5113663

(Division Sic

Division of Redicio, ical Davices

Vitro Diagnosue Device Evaluation and Safety

• 11. Volume Navigation/Image Fusions-only with the GPS transducer)

12. BM, BIPW Dopler or CW Dopler (Triplex) or CW Dopler (Tiplex CW), BPower Dopler or CW Do Simultaneous Color Doppier or Power Doppler.
    Office of in

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

m4DC7-3/40 Motorized Micro Convex Radius Transducer

Clinical Application	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes12	Other[Notes]
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
Adult Cephalic
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
Nerve Block
Other

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

N = New indication

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

Mary Postle

iDivision Sian-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K113663

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

L40-8/12 Linear Transducer

	Mode of Operation
Clinical Application	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

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

N = New indication

• Abdominal organs and vascular 1.
• 2. Breast, Thyroid, Testicle
• Elastography రా
• Panoramic Imaging 4.
• Compound Imaging 5.
• Freehand 3D Imaging 6.
• 7. Live 3D/4D Imaging
• Imaging for guidance of biopsy 8.
• Imaging for guidance of nerve block injections ல்
• 10. Imaging for guidance of central or peripheral lines
• 11. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transducer)
• 11. Volthe Nargalanting C Catheonixo C (Lithiado Shiy Mr. For of O Cansables)

12. BM, BJPW Dopler or CW Dopler (Triplex) or CW Dopler (Triplex CW), BPower Doppier/W Doppler Simultaneous Color Doppler or Power Doppler.

Mary Pastel

(Division Sign Division of Radiciogi. al Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K

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.