Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use in the device description or performance studies.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" used for "visualization of structures, and dynamic processes...to provide image information for diagnosis," indicating it is for diagnosis rather than therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the systems "provide image information for diagnosis." Additionally, the "Device Description" categorizes them as "mobile diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile diagnostic ultrasound system" and mentions employing "a wide array of probes," which are hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device description: The provided text describes a "Diagnostic Ultrasound System." Ultrasound is an imaging modality that uses sound waves to create images of structures within the body. It does not involve testing samples taken from the body.
Intended Use: The intended use clearly states the device is for "visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis." This is consistent with an imaging device, not an IVD.

Therefore, based on the provided information, the Aplio a550 and Aplio a450 are diagnostic imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (conventional and superficial), laparoscopic.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173090

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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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3

Transducer:

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

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
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] | |
|------------------------------------------------|---|---|-----|-----|---------------|-----------------------------------------|-----------|------------|------|-------|-----|--------------|-----|------------|----------------------|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|--|
| 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)

4

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)

5

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 Imaging
Combined (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)

6

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 Imaging
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	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)

7

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 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	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)

8

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 Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Precision Imaging
Combined (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)

9

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 Imaging
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]
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)

10

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 Application
Specific
(Tracks 3) | Mode of Operation | 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
(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 (Conventiona
I) | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 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	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 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	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 Imaging
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]
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 Imaging
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]
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 Imaging
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	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
Specific (Tracks 3)	B	M	PWD	CWD	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
Ophthalmic
Fetal
Abdominal	P	P	P		P
2	P	P		P			P			P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P
2	P	P		P			P			P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P		P
2	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
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 Application
Specific
(Tracks 3) | Mode of Operation
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
(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 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	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 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	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
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
Specific
(Tracks 3)	B	M	PWD	CWD	Precision Imaging
Combined (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 Imaging
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]
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
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
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 Application
Specific

(Tracks 3)	Mode of Operation
	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
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
1. OFFICIAL CORRESPONDENT Naofumi Watanabe
1. ESTABLISHMENT REGISTRATION: 9614698

4. CONTACT PERSON:

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

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/i600
Diagnostic Ultrasound
System, V2.4 | Canon Medical
Systems 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/a450
V2.8 | Aplio i600
V2.4 | 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 (4
connections) and Pencil | A/B/C/D Channels (4
connections) and Pencil | Same |
| B-Mode Depth | 1cm (min.).
50cm (max.) | 1cm (min.).
50cm (max.) | Same |
| Focusing
Number of transmit focus
points:
Reception focus: | Maximum of 8
Continuous | Maximum of 8
Continuous | Same |
| Transmission Frequency | Multiple frequencies are
selectable | Multiple frequencies are
selectable | Same |
| Operation Panel Tilt | No | Yes | Change |
| Fly Thru | No | Yes | Change |

39

| | Aplio a550/a450
V2.8 | Aplio i600
V2.4 | Comment |
|---------------------------------------|---------------------------------------------------------------------------|-------------------------|--------------------------------------|
| 510(K) Control Number | This Submission
(Subject) | K173090 | |
| Observation Monitor | a550:
23-inch (LED backlight)
a450:
21.5-inch (LED
backlight) | 23-inch (LED backlight) | Different sizes
available |
| Multi Harmonic Control | No | Yes | Not available on
the new system |
| Shear Wave Elastography | Yes | Yes | Previously cleared
under K173090* |
| Elastography | Yes | Yes | Previously cleared
under K173090* |
| Superb Microvascular
Imaging (SMI) | Yes (cSMI only) | Yes (cSMI and mSMI) | Previously cleared
under K173090* |
| Smart Fusion | Yes | Yes | Previously cleared
under K173090* |
| Smart Navigation | Yes (a550)
No (a450) | Yes | Previously cleared
under K173090* |
| Auto-NT | Yes | Yes | Previously cleared
under K173090* |
| 2D Wall Motion Tracking | Yes | Yes | Previously cleared
under K173090* |
| Auto EF Measurement | Yes | Yes | Previously cleared
under K173090* |
| CHI
Contrast Harmonic Imaging | Yes | Yes | Previously cleared
under K173090* |
| CHI-Q | Yes (a550)
No (a450) | Yes | Previously cleared
under K173090* |
| Shadow Glass | Yes (a550)
No (a450) | Yes | Previously cleared
under 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)

40

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.