Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

• K Number: K182427
• Device Name: Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
• Manufacturer: Canon Medical Systems Corporation
• Date Cleared: 2018-11-02 ( 57 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K173090
• Predicate For: K191663

Intended Use

The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 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), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

Device Description

The Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 are mobile diagnostic ultrasound systems. 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 20 MHz.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Aplio a550 and a450 Diagnostic Ultrasound Systems:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provided does not contain a specific table outlining acceptance criteria and reported device performance metrics in the format typically associated with diagnostic performance studies (e.g., sensitivity, specificity, AUC). Instead, the document focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and functionalities.

The acceptance criteria are implicitly met by the device's adherence to relevant international and national standards for medical devices and its functional equivalence to the cleared predicate device. The "reported device performance" in this context refers to the device's ability to perform its intended diagnostic ultrasound imaging functions, which is asserted through compliance with these standards and comparison to a predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with relevant industry standards (e.g., safety, EMC).	The Aplio a550 and a450 comply with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993-1, ISO 10993-10, and ISO 10993-5.
Functional equivalence to predicate device.	The Aplio a550/a450 systems function in a similar manner and are intended for the same use as the predicate device (Aplio i600 V2.4, K173090). Key features like scanning methods, B-mode depth, focusing, Shear Wave Elastography, Elastography, Superb Microvascular Imaging (SMI), Smart Fusion, Smart Navigation, Auto-NT, 2D Wall Motion Tracking, Auto EF Measurement, CHI, and CHI-Q are largely the same or have minor, non-critical differences compared to the predicate.
Safety and Efficacy for intended use.	Assessed through compliance with Quality System Regulations (21 CFR § 820) and ISO 13485 Standards, Risk Analysis, and Verification/Validation testing. No clinical studies were required to demonstrate safety and efficacy.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical studies were required to demonstrate safety and efficacy of the Aplio a550/a450 systems."

Therefore, there is:

• No specific sample size for a test set related to diagnostic performance.
• No data provenance (country of origin, retrospective/prospective) for a clinical test set because no clinical studies were performed for the 510(k) clearance of this specific device. The clearance relies on substantial equivalence to a previously cleared predicate device and engineering testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical studies were conducted for this 510(k) clearance, no experts were used to establish ground truth for a clinical test set for this specific submission.

4. Adjudication Method for the Test Set

As no clinical studies were conducted for this submission, no adjudication method was applied for a clinical test set.

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

No MRMC comparative effectiveness study was done for this 510(k) submission. The clearance is based on substantial equivalence to the predicate device, not on demonstrating improved human reader performance with AI assistance.

6. Standalone Performance Study (Algorithm Only)

The document primarily describes a diagnostic ultrasound system, not an AI algorithm as a standalone device. The functionalities mentioned (e.g., Shear Wave Elastography, SMI, Smart Fusion, Smart Navigation, Auto-NT, 2D Wall Motion Tracking, Auto EF Measurement, CHI, CHI-Q, Shadow Glass) are features of the ultrasound system itself. While some of these might involve advanced image processing or "smart" features that could be considered algorithmic, the submission does not present them as standalone AI algorithms with separate performance studies. The overall device's performance is demonstrated through compliance with standards and equivalence to its predicate.

Therefore, no standalone (algorithm only) performance study was reported in this 510(k) summary in the context of an AI algorithm.

7. Type of Ground Truth Used

Given that no clinical studies were required for this submission, no clinical ground truth data (like expert consensus, pathology, or outcomes data) was used to demonstrate the safety and efficacy of this specific device in this 510(k) submission. The regulatory pathway relied on non-clinical testing and comparison to a predicate device.

8. Sample Size for the Training Set

Since no clinical studies were required and the clearance is based on substantial equivalence and engineering testing, no training set for an AI model or similar clinical data set is described in this document. The "training" would implicitly refer to the development and internal validation processes of the system's software and hardware, which are part of the manufacturer's quality system.

9. How the Ground Truth for the Training Set Was Established

As no specific training set for an AI model or clinical data set is detailed, this information is not applicable and not provided in the document. The general "ground truth" for the device's functionality would stem from engineering specifications, phantom testing, and comparisons to established performance benchmarks of the predicate device, all verified through internal testing and adherence to stated standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

November 2, 2018

Re: K182427

Trade/Device Name: Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 4, 2018 Received: September 6, 2018

Dear Orlando Tadeo Jr.:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182427

Device Name

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

Indications for Use (Describe)

The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 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), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

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

N = new indication; P = previously cleared by FDA; E = added under this appendix 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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510(k) Premarket Notification Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

Clinical Application Mode of Operation Specific CMD ama ടിമ്പിച്ചു. അമ്രാ Other [Note] IN B OLL LINM d (Tracks 3) IƏMO, АЕМ ЛЕӘЧ TIC Colo FAM រជាមួយនឹងស្រីននា mart 3D ğısədç) pəuiquq əhəli dəyə qalınmışdır. Bu mərkəzi və bir mənasının qalınmışdır. Bu mərkəzi və bir mənistəsini mərkəzi və bir mənistəsini mərkəzi və bir mənistəsinə mərkəzi və bir mənistəsi icro Pur ງ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ ശ്രാ വ uoisn DITERIARN TIEW suiseur I uoisipa. Ophthalmic Fetal P Abdominal P P P P 3 P P b 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 P P P Adult Cephalic 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 P P P 3 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)

System: Aplio a550 and a450, Software V2.8 Transducer: PST-25BT

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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System: Aplio a550, Aplio a450 system ver.1.3

Transducer:_ PST-30BT

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) *	Color Doppler	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	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									5
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	5
Cardiac Pediatric	P	P	P	P	P	3					P	P										P	5
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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Transducer:_ PST-50BT

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) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	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
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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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	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	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
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3 P	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
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		5
Cardiac Pediatric	P	P	P	P	P	3 P	P			P	P										P 5
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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System: Aplio a550 and a450, Software V2.8 Transducer:__ PVT-375BT

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation	B	M	PWD	CWD	Precision ImagingCombined (Specify) *Color Doppler	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	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
Abdominal		P	P	P	P	2	P	P		P	P	P	P	P				P	P	P		4, 5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric		P	P	P	P	2	P	P		P			P					P	P	P		4
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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Transducer:_ PVT-375SC

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	Shear wave	4D(Volume color)	3D Color(Volume 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					4
Abdominal	P	P	P		P	2	P	P		P	P	P	P	P				P	P	P	P		4,5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P		P			P					P	P	P	P		4
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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Transducer:_ PVT-382BT

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

Clinical Application	Mode of Operation																			[Note]
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P		P				P			P	P	P		P	P		4
Abdominal	P	P	P	P	P	2	P	P	P		P				P			P	P	P	P	P	P		4,5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P		P				P			P	P	P		P	P		4
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer: PVT-475BT

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 DopplerCombined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal		E	E	E	E	2	E	E	E		E		E						E
Abdominal		E	E	E	E	2	E	E	E		E	E	E	E					E	E	E	E		4, 5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric		E	E	E	E	2	E	E	E		E		E						E	E	E	E		4
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (ConventionaI)
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 transducer: K151451 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

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	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D 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						P					4
Abdominal	P	P	P		P	2	P	P		P		P						P	P	P	P		4,5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P		P		P						P	P	P			4
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PVT-674BT

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	SMI	Shear wave	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
Abdominal	P	P	P	P	2	P	P		P			P					P					5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:___PVT-675MVL

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) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color(Volume 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	P					6
Abdominal	P	P	P	P	2	P	P	P	P		P		P	P	P	P	P					6
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PVT-675MVS

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) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color(Volume 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				6
Abdominal	P	P	P	P	2	P	P		P		P			P	P	P	P				6
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

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	CWD	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P											5
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					6
Trans-vaginal	P	P	P		P	2	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PVT-712BT

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	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P		P2	P	P		P			P					P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P2	P	P		P			P					P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P		P2	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PVT-745BTF

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	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P			P			P						P				5
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
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

PVT-745BTH 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	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P			P			P						P				5
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
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PVT-745BTV

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Specific(Tracks 3)
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P				P					P
Intra-operative (Abdominal)	P	P	P		P	2	P	P		P									P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:____PVT-781VT

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	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P			P										5
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		4
Trans-vaginal	P	P	P		P	2	P	P		P		P	P	P						P	P		4
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PVT-781VTE

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) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P				P										5
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		4
Trans-vaginal	P	P	P		P	2	P	P		P		P	P	P						P	P		4
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PVL-715RST

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 Imaging	Combined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	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	P	2	P	P	P		P													5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	P	2	P	P	P		P		P	P							P	P		4
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PLT-704SBT

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 Imaging	Combined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P			P													5
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

System: Aplio a550 and a450, Software V2.8 PLT-705BT Transducer:

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

Clinical ApplicationSpecific(Tracks 3)	Mode of OperationB	M	PWD	CWD	ColorDoppler	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P			P						P				5
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 transducer: K173090

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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PLT-705BTF

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	Shear wave	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			P						P
Intra-operative (Abdominal)	P	P	P	P	P	2	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PLT-705BTH

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	Shear wave	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			P						P
Intra-operative (Abdominal)	P	P	P	P	P	2	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PLT-1005BT

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	Combined (Specify) *	Precision Imaging	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P													5
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	P		4
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		4
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P	P	P		P	P					P	P	P		4
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		4
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PLT-1202BT

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) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	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	2	P	P	P	P	P			P						P	P			4
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	2	P	P	P	P	P			P						P	P			4
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			4
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	P	P			P						P	P			4
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
Other (Specify)								P

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PLT-1204BT

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	Precision ImagingCombined (Specify) *	Color Doppler	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P			P						P				5
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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer:_ PET-508MA

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	Shear wave	4D(Volume color)	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer: PET-512MC

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 Imaging	Micro Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer: PET-512MD

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) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	FusionSmart Navigation	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

Transducer: LA

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	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P		P												5
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic	P	P	P		P	2	P	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

System: Aplio a550 and a450, Software V2.8 Transducer:_ PC-20M

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	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	4D	3D Color(Volume 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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

510(k) Premarket Notification Aplio a550, Aplio a450 V1.3 Diagnostic Ultrasound System

System: Aplio a550 and a450, Software V2.8 Transducer: PC-50M

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation													Other	[Note]
	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Micro PureApli Pure	BEAM	Power	TDI	Elastography	SMI	Shear wave	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 transducer: K173090 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 Smart Sensor 3D

Note 5 CHI (Per FDA approved contrast agent prescribing information)

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

K182427

510(k) SUMMARY

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

4. CONTACT PERSON:

Orlando Tadeo, Jr. Sr. Manager, Requlatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 [phone]

5. DATE PREPARED: October 31, 2018

6. DEVICE NAME:

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

TRADE NAME(S): 7.

Diagnostic Ultrasound System Aplio a550 Model CUS-AA550 Diagnostic Ultrasound System Aplio a450 Model CUS-AA450

COMMON NAME: 8.

System, Diagnostic Ultrasound

9. 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]

10. PREDICATE DEVICE:

Product	Marketed by	510(k)Number	Clearance Date
Aplio i900/i800/i700/i600Diagnostic UltrasoundSystem, V2.4	Canon MedicalSystems USA, Inc	K173090	January 11, 2018

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

11. REASON FOR SUBMISSION:

New device

12. DEVICE DESCRIPTION:

The Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 are mobile diagnostic ultrasound systems. 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 20 MHz.

13. INDICATIONS FOR USE:

The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 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.

14. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aplio i600 V2.4 Diagnostic Ultrasound System, 510(k) cleared under K173090, marketed by Canon Medical Systems USA, Inc. The Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 function in a manner similar to and is intended for the same use as the predicate device referenced within this submission. The subject device includes modifications to the cleared device. The subject device is a compact diagnostic ultrasound system by implementing latest technologies.

	Aplio a550/a450V2.8	Aplio i600V2.4	Comment
510(K) Control Number	This Submission(Subject)	K173090
Scanning Method	Electronic Convex,Electronic Sector,Electronic Linear,Pencil	Electronic Convex,Electronic Sector,Electronic Linear,Pencil	Same
Probe Selector	A/B/C/D Channels (4connections) and Pencil	A/B/C/D Channels (4connections) and Pencil	Same
B-Mode Depth	1cm (min.).50cm (max.)	1cm (min.).50cm (max.)	Same
FocusingNumber of transmit focuspoints:Reception focus:	Maximum of 8Continuous	Maximum of 8Continuous	Same
Transmission Frequency	Multiple frequencies areselectable	Multiple frequencies areselectable	Same
Operation Panel Tilt	No	Yes	Change
Fly Thru	No	Yes	Change

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	Aplio a550/a450V2.8	Aplio i600V2.4	Comment
510(K) Control Number	This Submission(Subject)	K173090
Observation Monitor	a550:23-inch (LED backlight)a450:21.5-inch (LEDbacklight)	23-inch (LED backlight)	Different sizesavailable
Multi Harmonic Control	No	Yes	Not available onthe new system
Shear Wave Elastography	Yes	Yes	Previously clearedunder K173090*
Elastography	Yes	Yes	Previously clearedunder K173090*
Superb MicrovascularImaging (SMI)	Yes (cSMI only)	Yes (cSMI and mSMI)	Previously clearedunder K173090*
Smart Fusion	Yes	Yes	Previously clearedunder K173090*
Smart Navigation	Yes (a550)No (a450)	Yes	Previously clearedunder K173090*
Auto-NT	Yes	Yes	Previously clearedunder K173090*
2D Wall Motion Tracking	Yes	Yes	Previously clearedunder K173090*
Auto EF Measurement	Yes	Yes	Previously clearedunder K173090*
CHIContrast Harmonic Imaging	Yes	Yes	Previously clearedunder K173090*
CHI-Q	Yes (a550)No (a450)	Yes	Previously clearedunder K173090*
Shadow Glass	Yes (a550)No (a450)	Yes	Previously clearedunder K173090*

• No change to basic function

15. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.

16. TESTING

Risk Analysis, Verification/Validation testing conducted, which are included, demonstrates that the requirements for the features have been met.

The Aplio a550 and Aplio a450 comply with voluntary standards:

• . ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)

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• IEC 60601-1-2 Edition 3: 2007-03 ● Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
• . IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• IEC 62304:2006+A1:2015 Medical device software Software life cycle processes ●
• ISO 10993-1 Fourth edition 2009-10-15 . Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]
• ISO 10993-10 Third Edition 2010-08-01 . Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• . ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

This submission was prepared in conformance with FDA Guidance Document: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Issued September 2008,

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.

No clinical studies were required to demonstrate safety and efficacy of the Aplio a550/a450 systems.

17. CONCLUSION

The Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 are substantially equivalent to the predicate device. The subject devices function in a manner similar to and is intended for the same use as the predicate device, as described in the labeling. Based upon the successful completion of software validation, application 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.