The Diagnostic Ultrasound Systems Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

Device Description

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600, V4.0 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 30 MHz.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0. The submission claims substantial equivalence to previously cleared devices and includes information on new and improved features, along with testing details.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of "acceptance criteria" with specific quantitative thresholds. Instead, it describes what each study confirmed. The general acceptance criterion implied throughout the document for new features is "substantially equivalent to the predicate function" and for improvements, "met specifications and performed as intended." For workflow improvements, the implied criterion is "faster and easier workflow" or "workflow is improved."

Here's a summary of the reported device performance for each feature, interpreted as meeting the implied acceptance criteria:

Feature / Improvement	Acceptance Criteria (Implied)	Reported Device Performance
Aortic Valve Analysis (AV Analysis)	Measurement values are substantially equivalent to predicate function. Provides faster and easier workflow compared to predicate.	Confirmed that AV Analysis provides measurement values of the aortic valve complex that are substantially equivalent to those by the predicate function. Confirmed that this function provides a faster and easier workflow in comparison to the predicate function.
BI-RADS Checklist	Provides standardized checklist options according to ACR BI-RADS. Establishes a worksheet displaying check items in specified layout.	Confirmed that this function provides a check list with options standardized according to ACR BI-RADS and that this function establishes a worksheet displaying check items in the specified layout.
TI-RADS Checklist	Provides standardized checklist options according to ACR TI-RADS and provides clinical assessments (risk classification). Establishes a worksheet displaying check items in specified layout.	Confirmed that this subject function provides a check list with options standardized according to ACR TI-RADS and automatically provides clinical assessments (risk classification in terms of Thyroid cancer) standardized according to ACR TI-RADS and that this function establishes a worksheet displaying check items in the specified layout.
2D Wall Motion Tracking for Fetal Heart one cycle detection	Measurement values are substantially equivalent to predicate function. Operation time is reduced. Automatically provides clinically appropriate candidate one heart cycle period. Workflow is improved.	Confirmed that the measurement values by the subject function are substantially equivalent to the predicate function and that the operation time is reduced as compared to the predicate function. Confirmed that the subject function automatically provides a clinically appropriate candidate one heart cycle period and that workflow is improved by comparison of the subject function to the predicate.
Color Doppler imaging	Improved visibility of blood flow.	Results demonstrated that the improvements met specifications and performed as intended.
Volume rendering view (Mecha4D)	Previously available only in MPR view; now improved.	Results demonstrated that the improvements met specifications and performed as intended. (Comment indicates "Previously only available in MPR view -Improvement")
Mitral Valve Analysis (MVA) (A2/P2 length)	Addition of parameters leads to improvement.	Results demonstrated that the improvements met specifications and performed as intended. (Comment indicates "Addition of parameters -Improvement")
Auto E/A	Automation of previously manual measurements leads to improvement.	Results demonstrated that the improvements met specifications and performed as intended. (Comment indicates "Automation of previously manual measurements -Improvement")

2. Sample Averages for Test Set and Data Provenance

The document does not provide specific sample sizes (number of cases or images) for the test set used in performance testing, nor does it specify the country of origin of the data. The studies are described as "bench assessment" and "clinical evaluation," implying that both synthetic/controlled data and real clinical data were used. It does not state whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It implicitly refers to "clinical evaluation" and "clinically appropriate candidate" for some features, suggesting medical professionals were involved in assessing the results, but details are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it quantify any effect size of improvement. The studies described focus on the device's performance against predicate functions or specifications, and workflow efficiency.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The document primarily discusses the device's functions and improvements, and its performance relative to predicate functions. For several features (AV Analysis, 2D WMT, Auto E/A), it compares the device's measurements/automation to that of a "predicate function," which implies a standalone performance assessment of the new/improved algorithmic features, though not explicitly an "algorithm-only" study in isolation from the ultrasound system itself. For example, "AV Analysis provides measurement values... substantially equivalent to those by the predicate function" suggests a direct comparison of the algorithmic output.

7. Type of Ground Truth Used

The ground truth appears to be established by comparison to "predicate functions" and implicitly, "clinically appropriate" assessments by unspecified medical professionals in "clinical evaluations." For the BI-RADS and TI-RADS checklists, the ground truth is standardization according to ACR BI-RADS and ACR TI-RADS guidelines, respectively. This implies a standard of care/expert consensus as a form of ground truth.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set for any AI/machine learning components.

9. How Ground Truth for the Training Set was Established

The document does not describe how ground truth was established for the training set. Given that this is a 510(k) for an ultrasound system with improved features and some new features, it's possible that many improvements are algorithmic enhancements or automation rather than deep learning requiring extensive labeled training data in the AI sense. However, for features like "Auto E/A" and "2D Wall Motion Tracking for Fetal Heart one cycle detection," some form of training data and associated ground truth would likely be involved, but this information is not detailed in the provided text.

Summary

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July 19, 2019

Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K191467

Trade/Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: Mav 31, 2019 Received: June 3, 2019

Dear Mr. Tadeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191467

Device Name

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Transducer:

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Combined (Specify)	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	TDI	Shear waveSMI(ADF)	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Smart Navigation	Fusion	2D WMT	Other [Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P		P	P		P	P	P	P	P	P	P		P	6,8
Abdominal	P	P	P	P	P	2,3	P	P		P		P	P	P	P	P	P	P	P	P		4,5,6,7,8
Intra-operative (Abdominal)	P	P	P		P	2	P	P		P									P
Intra-operative (Neuro)
Laparoscopic	P	P	P		P	2	P	P		P		P	P
Pediatric	P	P	P	P	P	2,3	P	P		P			P	P	P	P	P	P	P	P	P	6,8
Small Organ (Note 1)	P	P	P		P	2	P	P	P	P	P		P	P	P				P	P	P	6
Neonatal Cephalic	P	P	P	P	P	3	P			P
Adult Cephalic	P	P	P	P	P	3	P			P			P		P					P		6,
Trans-rectal	P	P	P		P	2	P	P		P		P	P	P	P	P				P	P	8
Trans-vaginal	P	P	P		P	2	P	P		P		P	P	P	P	P				P	P	8
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P	P	P		P	P					P	P	P	6,8(N)
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P	P	P		P	P					P	P	P	6,8(N)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P			P	P		P	P						P		7,8,9,10
Cardiac Pediatric	P	P	P	P	P	3	P			P	P		P	P								7,8,9,10
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P				P		P	P								8,10,11
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P	P	P		P	P					P	P	P	6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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System: Aplio i900, i800, i700,i600 V4.0 Transducer: PST-28BT*

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

Clinical Application	Mode of Operation
	Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	3	P	P		P				P						P		6(P),7(P),8(P)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic		P	P	P	P	P	3	P			P
Adult Cephalic		P	P	P	P	P	3	P			P			P						P			6(P)
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult		P	P	P	P	P	3	P			P	P								P		P	7(P),8(P)
Cardiac Pediatric		P	P	P	P	P	3	P			P	P										P	7(P),8(P)
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

Note 11 Mitral Valve Analysis

*This transducer Model Name was incorrectly listed as "PSI-28BT" in predicate submission K182679. The correct reference was provided to FDA in "Add to file K182679".

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Transducer:

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P				P			P							P	P		6(P)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P				P			P							P	P		6(P)
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P				P
Adult Cephalic	P	P	P	P	P	3	P				P			P							P			6(P)
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P				P	P		P							P		P	7
Cardiac Pediatric	P	P	P	P	P	3	P				P	P		P							P		P	7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 ATI Note 5 Tissue Intensity Analysis Note 6 Sensor3D Note 7 CHI (Per FDA approved contrast agent prescribing information) Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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Transducer: PSI-70BT

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

Clinical Application Mode of Operation

Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Power	TDI	SMI(ADF)	2D WMT	Other [Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P		P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P		P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P
Adult Cephalic	P	P	P	P	P	3		P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P		P	7
Cardiac Pediatric	P	P	P	P	P	3	P	P	P		P	7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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Transducer: PST-25BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Precision Imaging	Combined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P			P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P			P		P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P			P		P
Adult Cephalic	P	P	P	P	P	3	P			P		P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P			P	P											P
Cardiac Pediatric	P	P	P	P	P	3	P			P	P											P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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PST-30BT Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Power	TDI	Shear wave	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P		P		7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P		P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3		P
Adult Cephalic	P	P	P	P	P	3	P	P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3		P	P		P	7
Cardiac Pediatric	P	P	P	P	P	3		P	P		P	7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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PST-50BT Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Power	TDI	SMI(ADF)	Smart Navigation
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P		P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P		P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3		P
Adult Cephalic	P	P	P	P	P	3		P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3		P	P		P
Cardiac Pediatric	P	P	P	P	P	3		P	P		P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer:PST-65BT

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

Clinical Application | Mode of Operation

Clinical ApplicationSpecific(Tracks 3)	Mode of OperationB	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Micro PureApli Pure	TDI	Shear waveElastography	SMI(ADF)	2D WMT
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	3	N	N		N
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	N	N	N	N	N	3	N	N	N		N
Cardiac Pediatric	N	N	N	N	N	3	N	N	N		N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: N/A Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PSI-30VX Transducer:

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

Clinical Application	Mode of
----------------------	---------

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	Shear waveSMI(ADF)	4D(Volume color)3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3 P	P			P			P	P	P			P	P		7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3 P	P			P			P	P	P			P	P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	3 P	P			P			P		P				P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3 P	P			P	P		P	P	P					P	7,8,9,10
Cardiac Pediatric	P	P	P	P	P	3 P	P			P	P		P	P	P					P	7,8,9,10
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BD/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PSI-40VX Transducer:

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

Clinical Application	Mode of
----------------------	---------

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal	P	P	P	P	P	2					P			P		P	P
Abdominal	P	P	P	P	P	3	P				P			P		P	P				P			7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P				P			P		P	P				P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P				P	P				P	P						P	7,8,9,10
Cardiac Pediatric	P	P	P	P	P	3	P				P	P				P	P						P	7,8,9,10
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BD/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PSI-50VX Transducer:

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

Mode of Operation Clinical Application

ாறியின் 1 ர்நாவில்ப	191000 01 0 00000000
Specific(Tracks 3)	B	M	ama	am	played be	gipəds) pəuiqulo	ສິນເກີຣ໌ເພາະ ແດນຣາເວອາ	and liqu	iceo Purce	MAGA	www.	IQT	បុបមរភិបាល ប្រជាជាតិ	ACA)IM	Shear wave	C	a supportunion	OLLS	STIC Color	DE 118m	uoisn F	oilsgiven 118m	LINM az	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2					P			P		P	b
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	b				P			P		P	b				P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	b	b	b	P	3	b				P	b				b	b						b	7,8,9,10
Cardiac Pediatric	P	b	b	P	P	3	P				b	b				P	P						b	7,8,9,10
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BD/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PVI-475BT

sound imaging or fluid flow analysis of the human body as follows: Intended Use: Diagnostic ult

	mended OSE. Diagnostic untrasound imaging of Truid now andrySis
Clinical Application	Mode of Operation

Specific(Tracks 3)	B	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Power	TDI	Elastography	SMI(ADF)	Shear wave	STIC Color	Smart 3D	Fusion	Smart Navigation	Other[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P	P		P		P			P
Abdominal	P	P	P	P	2	P	P	P		P	P	P		P	P	P	6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P			P			P	P	P	6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PVI-475BX

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

Clinical Application Mode of Operation

.
Specific(Tracks 3)	B	M	ama	am	aldo (10)o	ırəədç) pəuiquno	รับเชิริย์น์ แบรรเวอส	il Pulle	ice Purce	MAGE	Power	IQI	បុបមរភិបាលប្រជាជា	ACLA)IM	SEEM Ware	C	a supportunities and	SITS	STCCCCcccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccc	DE Premi	uoisn	DITERIARN 11811	LINM az	Other[Note]
Ophthalmic
Fetal	P	b	b		P	2	P	P			P	P		P						P			P
Abdominal	P	P	P		P	2	P	P			P		P	P	P					P	P	P		4,5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	b	b		P	2	P	b			P			P						P	P	b		6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PVI-482BX

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	ama	ന്നും വക്ഷേത്രം അവലംബം പ്രശസ്തമായി വിവ്യത്തിന്റെ വിശ്വാസം വേണ്ടുന്നു. അവലംബം അവലംബം പ്രശസ്ത്രവും വയസ്തുന്നും അവലംബം പ്രശസ്ത്രത്തിനും അവലംബം അവലംബം അവലംബം അവലംബം	ologic proposition	(yıɔədç) pəuiqur	รินทุกิชานี แบบริเวอ	ərə qalında çəkildən bir və qalınmışdır. Bu mərkəzi və qalınmışdır. Bu mərkəzi və qalınmışdır. Bu mərkəzi və qalınmışdır. Bu mərkəzi və qalınmışdır. Bu mərkəzi və qalınmışdı	Micro Purce	MA.MI	Power	IQI	ប្រជាជនជាតិ	ACLA)IM	Shew wave	a suppo suppo de	SITS	TTCCCCGGTC	Surfamis	uoisn	its given 118m	LINK OZ	Other[Note]
Ophthalmic
Fetal	N	N	N		N	2	N	N			N			N					N				6
Abdominal	N	N	N		N	2	N	N			N			N					N	N	N		6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	2	N	N			N			N					N	N	N		6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A

Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PVT-574BT

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

Clinical Application Mode of Operation

Clinical ApplicationSpecific(Tracks 3)	Mode of OperationB	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	BEAM	Power	SMI(ADF)	Elastography	Shear wave	Smart 3D	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal	P	P	P	P	P	P	P	P	P		P		P			P	6(P), 8(P)
Abdominal	P	P	P	P	P	P	P	P	P	P	P	P	P	P	P	P	6(P),7(P),8(P)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	P	P		P		P	P	P		6(P),8(P)
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PVI-574BX

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

Clinical Application

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	Power	TDI	Shear waveSMI(ADF)	4D(Volume color)	STIC Color	Smart 3D	Fusion	Smart Navigation	Other
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P	P	P		P		P	P	6(P), 8(P)
Abdominal	P	P	P	P	P	2	P	P	P		P	P	P	P	P	P	6(P),7(P),8(P)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P		P		P	P	P		6(P),8(P)
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

uoisn the the mig INM (1) Other

[Note]

SILS

TIC CC

e pristi

System: Aplio i900, i800, i700, i600 V4.0

Transducer: PVT-482BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color(Volume color)

Ophthalmic
Fetal	P	P	P	P	2	P	P	P	P	P			6
Abdominal	P	P	P	P	2	P	P	P	P	P	P	P	6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	P	P	P	P	6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-375BT Transducer:

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

Clinical Application | Mode of Operation

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	Power	TDI	Elastography	Shear wave	SMI(ADF)	STIC Color	Smart 3D	Fusion	Smart Navigation	Other[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P					P
Abdominal	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	4, 5, 6, 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P					P	P	P	P	6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-375SC Transducer:

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

Clinical Application Mode of Operation

1 1000 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Specific(Tracks 3)	B	M	ama	ന്നും വഹാ	Clor Dople	(Ajisədç) pəuiquvo	guigeml uoisiper	and liqu	Micro Pure	MA.MA	ower	Idl	קלא מערכת המועד לינוע לא מערכת המועד ליינו לא מעולם למשלה במשלב את המועד המועד למשלה במשלב המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המוע	FICA)IM	SAEM MEVE	ਹ	alolos aminon) af	OLLS	TIC Colo	DE 118m	uoisn	DIEBIAEN 118m	LINM az	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P			P			b						P				6
Abdominal	P	P	P		P	2	P	P			P		P	P	b					P	P	P		4,5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P			P			b						P	P	P		ર્ભ
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-382BT Transducer:

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

Clinical Application	Mode of Operation

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation																				Other [Note]
	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal	P	P	P		P	2	P	P		P			P					P		P	P			6
Abdominal	P	P	P		P	2	P	P		P			P					P	P	P	P		6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P		P			P					P	P	P	P		6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-674BT Transducer:

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

Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	Power	TDI	Elastography	SMI(ADF)	STIC	Smart 3D	Smart Navigation	2D WMT
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P
Abdominal	P	P	P	P	P	2	P	P	P	P		P	P	P			7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P	P		P	P	P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-675MVL Transducer:

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	Shear waveSMI(ADF)	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P		P		P		P	P	P	P				P	8
Abdominal	P	P	P		P	2	P	P		P		P		P	P	P	P					8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P		P		P		P	P	P	P					8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI
Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PVT-675MVS

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	TDI	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	2D WMT	Other [Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P	P	8
Abdominal	P	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P		8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P		8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI
Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PVT-681MVL

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	BEAM	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color(Volume color)	Other
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P							7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	2	P	P	P	P	P	P	P	P	P	8
Trans-vaginal	P	P	P	P	2	P	P	P	P	P	P	P	P	P	8
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-712BT Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	Power	Shear wave	Smart 3D
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P	P	P	P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P	P	P	P
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	2	P	P	P	P	P	P
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-745BTF Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation													Other [Note]
	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	Shear waveSMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P		P			P						P			7
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P		P			P						P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P		P			P						P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-745BTH Transducer:

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

Clinical Application	Mode of Operation

Specific(Tracks 3)	B	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	BEAM	Elastography	SMI(ADF)	Smart 3D	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P	P	P	P	7
Intra-operative (Abdominal)	P	P	P	P	2	P	P	P	P	P	P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	2	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-745BTV Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	BEAM	Elastography	SMI(ADF)	STIC Color	Smart Navigation
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P	P	P	P
Intra-operative (Abdominal)	P	P	P	P	2	P	P	P			P	P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	2	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVT-781VT Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	Power	Elastography	SMI(ADF)	Shear wave	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P		P				7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	2	P	P	P	P	P	P	P	P		6
Trans-vaginal	P	P	P	P	2	P	P	P	P	P	P	P	P		6
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Power	TDI	Elastography	SMI(ADF)	Shear wave	Smart 3D	Fusion	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P			P					7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	6
Trans-vaginal	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	6
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

PVL-715RST Transducer:

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

Clinical Application	Mode of C
----------------------	-----------

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P		P													7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P		P	P	P	P							P	P		6
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PVT-770RT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application					Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	2	P	P		P		P
Trans-vaginal	P	P	P		P	2	P	P		P		P
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

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

Transducer: PLI-1205BX

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical Application	Mode of Operation															[Note]
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P													7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P	P	P		P	P	P					P	P	P		6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P	P	P		P	P						P	P	P		6,8
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P	P	P		P	P						P	P	P		6,8
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P	P	P		P	P						P	P	P		6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{36}------------------------------------------------

Transducer: PLI-2002BT

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical Application		Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P		P			P						P	P			6
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P		P			P						P	P			6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	P	2	P	P	P		P			P						P	P			6
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P		P			P						P	P			6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P		P		P	P						P	P			6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K182679

Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{37}------------------------------------------------

Transducer: PLI-2004BX

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

Mode of Operation Clinical Application

Specific(Tracks 3)	B	M	PWD	Color Doppler	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	Power	TDI	SMI(ADF)	Shear wave	Smart 3D	Fusion	Smart Navigation	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	2	P	P	P	P	P	P	P	P	P	6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	2	P	P	P	P	P	P	P	P	P	6,8
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	P	P	P	P	P	P	6,8
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	2	P	P	P	P	P	P	P	P	P	6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{38}------------------------------------------------

Transducer: PLI-3003BX

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

Clinical Application

Clinical Application(Tracks 3)	Specific	B	M	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Power	SMI(ADF)	Smart 3D	Fusion	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	2	P	P	P	P	P	P	6(P)
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	P	P	P	6(P),8(P)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{39}------------------------------------------------

PLT-704SBT Transducer:

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

Clinical Application	Mode of Operation

Specific(Tracks 3)	B	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Power	TDI	Shear waveSMI(ADF)	Fusion	Other [Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P				7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	2	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	2	P	P	P	P	P	P
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	P	P	P
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	2	P	P	P	P	P	P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{40}------------------------------------------------

PLT-705BT Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	BEAM	Power	Shear wave	STIC Color	Other [Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P		P	P	7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	2	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	2	P	P	P	P	P	P
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	P	P	P
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	2	P	P	P	P	P	P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{41}------------------------------------------------

PLT-705BTF Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical Application	Mode of Operation																		Other	[Note]
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P		P			P		P					P
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P		P			P		P					P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{42}------------------------------------------------

PLT-705BTH Transducer:

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P			P			P		P				P
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P			P			P		P				P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{43}------------------------------------------------

PLI-705BX Transducer:

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

Clinical Application	Mode of
----------------------	---------

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	BEAM	Power	Shear wave	Smart 3D	Fusion	Other [Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P	P	P	P	P	6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	2	P	P	P	P	P	P	P	6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	2	P	P	P	P	P	P	P	6
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	P	P	P	P	6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	2	P	P	P	P	P	P	P	6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{44}------------------------------------------------

PLT-1005BT Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	Smart 3D	Fusion	Smart Navigation	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P	P											7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P	P	P	6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P	P	P	6,8
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P	P	P	6,8
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P	P	P	6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{45}------------------------------------------------

Transducer:

ntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Precision Imaging	Combined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	Elastography	SMI(ADF)	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P		P		P							P	P			6
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P		P		P							P	P			6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	P	2	P	P		P		P							P	P			6
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P		P		P							P	P			6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P		P	P	P							P	P

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{46}------------------------------------------------

Transducer: PLT-1204BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	Shear waveSMI(ADF)	4D(Volume color)	3D ColorSTIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P	P			P				P					7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	2	P	P	P	P	P	P	P				P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	2	P	P	P	P	P	P	P				P					8
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	P	P	P	P				P					8
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	2	P	P	P	P	P	P	P				P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{47}------------------------------------------------

PET-508MA Transducer:

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

Clinical Application Mode of Operation

Clinical ApplicationSpecific(Tracks 3)	Mode of OperationB	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	TDI	2D WMT
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P	P	P
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{48}------------------------------------------------

Transducer: PET-512MC

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

Clinical Application Mode of Operation

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	TDI
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P	P
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{49}------------------------------------------------

Transducer: PET-512MD

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	Elastography	TDI	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P		3	P					P										P
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{50}------------------------------------------------

Transducer: PEI-512VX

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

Clinical Application	Mode of Operation
Specific (Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color (Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					P				P							P		8,9,10,11
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{51}------------------------------------------------

PET-805LA Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Specific(Tracks 3)	B	M	PWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	BEAM	TDI	Elastography	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P			7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic	P	P	P	P	2	P	P	P	P	P
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{52}------------------------------------------------

PC-20M Transducer:_

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

Clinical Application	Mode of Operation											Other	[Note]
Specific (Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Elastography	Power	TDI	Shear wave	SMI(ADF)	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric			P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult			P
Cardiac Pediatric			P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel			P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{53}------------------------------------------------

Toshiba America Medical Systems, Inc.

510(k) Premarket Notification Aplio i900, i800, i700 V3.1 Diagnostic Ultrasound System

System: Aplio i900, i800, i700, i600 V4.0 Transducer: PC-50M

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric			P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult			P
Cardiac Pediatric			P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel			P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

{54}------------------------------------------------

SYSTEMS USA, INC.

510(k) SUMMARY

1. SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
1. OFFICIAL CORRESPONDENT Naofumi Watanabe
ESTABLISHMENT REGISTRATION: 3. 9614698

4. CONTACT PERSON:

Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

1. Date Prepared: May 31, 2019

6. TRADE NAME(S):

Diagnostic Ultrasound System Aplio i900 Model TUS-AI900 Software Version V4.0 Aplio i800 Model TUS-AI800 Software Version V4.0 Aplio i700 Model TUS-AI700 Software Version V4.0 Aplio i600 Model TUS-AI600 Software Version V4.0

7. COMMON NAME:

System, Diagnostic Ultrasound

8. DEVICE CLASSIFICATION:

Class II

Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer – Product Code: 90-ITX [per 21 CFR 892.1570]

{55}------------------------------------------------

9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Aplio i900/i800/i700 DiagnosticUltrasound System, V3.1(Primary Predicate Device)	Canon MedicalSystems USA	K182679	October 31, 2018
ACUSON SC2000 DiagnosticUltrasound System	Siemens MedicalSolutions USA, Inc	K181098	May 31, 2018
AIXPLORER® MACH UltrasoundDiagnostic Systems	SupersonicImagine	K180572	May 29, 2018

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aplio i900/i800/i700/i600, Diagnostic Ultrasound System, V3.1, K182679, marketed by Canon Medical Systems USA. The Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-Al800, Aplio i700 Model TUS-A1700 and Aplio i600 Model TUS-A1600, V4.0 function in a manner similar to and is intended for the same use as the predicate devices. The subject device includes modifications to the cleared device which improves upon existing features. This submission also includes details regarding new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission.

{56}------------------------------------------------

New features and Improvements to previously cleared functions:

Device	Aplioi900/i800/i700/i600V4.0	ACUSONSC2000DiagnosticUltrasoundSystem	AIXPLORER®MACHUltrasoundDiagnosticSystems	Comment
510(k) ClearanceNumber	SubjectDevice	K181098	K180572
Aortic ValveAnalysis(AV Analysis)	Yes (i900)	Yes		New Feature
BI-RADS Checklist	Yes		Yes	New Feature
TI-RADS Checklist	Yes		Yes	New Feature

	Aplio i900/i800/i700V4.0	Aplio i600V4.0	Comment
PST-65BT	Yes	Yes	New transducer
PVI-482BX	Yes	No	New transducer

Device	Aplio i900/i800/i700/i600(V3.1)	Aplio i900/i800/i700(V4.0)	Aplio i600(v4.0)	Comment
510(k) ClearanceNumber	K182679	Subject Device	Subject Device
DopplerLuminance	No	Yes	Yes	Improved visibility ofblood flow, ColorDoppler imaging-Improvement
Volumerendering view(Mecha4D)	No	Yes	Yes	Previously onlyavailable in MPRview-Improvement
2D WMT FetalHeart-FetalOne cycledetection	No	Yes	Yes	Automatedcandidate heart cycledetection-Improvement
MVA (MitralValve Analysis)-A2/P2 length	No	Yes	No	Addition ofparameters-Improvement
Auto E/A	No	Yes	Yes	Automation ofpreviously manualmeasurements-Improvement

{57}------------------------------------------------

14. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the AAMI/ANSI ES60601-1:2012, IEC 60601-1-2 (2014), IEC 60601-2-37 (2015), IEC 62304 (2015), AIUM RTD2-2004 Output Display and ISO 10993-1(2009) standards.

15. TESTING

Risk Analysis, Verification/Validation testing conducted through bench testing and clinical evaluation which are included in this submission demonstrates that the requirements for the new and improved features have been met.

15.1 Performance Testing – Assessment of New Feature, Aortic Valve Analysis (AV Analysis) Bench Assessment of AV Analysis

This study confirmed that AV Analysis provides measurement values of the aortic valve complex that are substantially equivalent to those by the predicate function.

Clinical Evaluation of AV Analysis

This study confirmed that this function provides a faster and easier workflow in comparison to the predicate function.

15.2 Performance Testing - Assessment of New Feature, BI-RADS Checklist

This study confirmed the following: I) that this function provides a check list with options standardized according to ACR BI-RADS and that (II) this function establishes a worksheet displaying check items in the specified layout.

15.3 Performance Testing - Assessment of New Feature, TI-RADS Checklist

This study confirmed the following: I) that this subject function provides a check list with options standardized according to ACR TI-RADS and automatically provides clinical assessments (risk classification in terms of Thyroid cancer) standardized according to ACR TI-RADS and that (II) this function establishes a worksheet displaying check items in the specified layout.

15.4 Performance Testing - Assessment of Improved Feature, 2D Wall Motion Tracking for Fetal Heart one cycle detection

Bench Assessment of 2D Wall Motion Tracking for Fetal Heart one cycle detection

This study confirmed the following: that I) the measurement values by the subject function are substantially equivalent to the predicate function and (II) that the operation time is reduced as compared to the predicate function.

Clinical Evaluation of 2D Wall Motion Tracking for Fetal Heart one cycle detection

This study confirmed the following: I) that the subject function automatically provides a clinically appropriate candidate one heart cycle period and (II) that workflow is improved by comparison of the subject function to the predicate.

{58}------------------------------------------------

Additional performance testing, using test data and volunteer studies, was conducted to assess improvements to existing features including Color Doppler image processing, 4D measurements, Mitral Valve Analysis, and E/A measurements. Results of all these studies demonstrated that the improvements met specifications are performed as intended.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Additionally, testing of this device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.

16. CONCLUSION

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-Al600, V4.0 is substantially equivalent to the predicate devices. The subject devices function in a manner similar to and is intended for the same use as the predicate devices, as described in the labeling. Based upon the bench testing, clinical evaluation, successful completion of software validation of risk management and design controls, it is concluded that this device is safe and effective for its intended use.

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.