The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G 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), laparoscopic, pediatric, small organs, neonalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Device Description

The Xario200G Model CUS-X200G and Xario100G Model CUS-X100G 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 12 MHz.

AI/ML Overview

This FDA 510(k) summary document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study for the device's performance in a clinical context (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC).

Instead, the document highlights that the new device, Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System, functions similarly and is intended for the same use as its predicate (Xario 200 Diagnostic Ultrasound System V6.0, K172276).

Therefore, specific acceptance criteria related to diagnostic performance (like those for AI/ML devices) and a study proving the device meets those criteria in terms of clinical accuracy are not present in this document. The "testing" mentioned refers to engineering and software validation tests.

Here's a breakdown of the information that can be extracted and what is not available in the provided text:

1. A table of acceptance criteria and the reported device performance

Not Available directly in terms of clinical performance metrics. The document states "Risk Analysis, Verification/Validation testing conducted which are included in this submission demonstrates that the requirements for the features have been met." This implies internal engineering and functional acceptance criteria were met, but specific quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) deemed as acceptance criteria are not provided. The comparison table (page 32) focuses on technical specifications to demonstrate equivalence, not performance against specific clinical acceptance thresholds.

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

Not Available for clinical performance testing. The document explicitly states: "No clinical studies were required to demonstrate safety and efficacy of the Xario200G/Xario100G systems." This indicates that there was no test set of patient data used for clinical performance evaluation as part of this submission. The testing revolved around non-clinical aspects.

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

Not Applicable. Since no clinical studies or test sets with patient data were conducted for clinical performance, there was no need for experts to establish ground truth for such a test set.

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

Not Applicable. As no clinical performance study was conducted.

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

Not Applicable. This device is a diagnostic ultrasound system, not an AI-assisted device for interpretation. Furthermore, no clinical studies were performed.

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

Not Applicable. This is a hardware/software system, not an algorithm in the sense of a standalone AI model. No clinical performance testing (standalone or otherwise) was reported as being done.

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

Not Applicable for clinical performance. For the non-clinical testing conducted, the ground truth would be established by engineering specifications, regulatory standards, and internal quality control measures.

8. The sample size for the training set

Not Applicable. No AI/ML model training data is discussed for this device.

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

Not Applicable. No AI/ML model training data is discussed for this device.

Summary from the document:

This 510(k) submission for the Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System is based on demonstrating substantial equivalence to a previously cleared predicate device (Xario 200 Diagnostic Ultrasound System V6.0, K172276). The "testing" mentioned in the document refers to Risk Analysis, Verification/Validation testing, and adherence to applicable standards (e.g., IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004 Output Display and ISO 10993-1). The document explicitly states: "No clinical studies were required to demonstrate safety and efficacy of the Xario200G/Xario100G systems." Therefore, information regarding clinical acceptance criteria, sample sizes for clinical test sets, ground truth establishment by experts, adjudication methods, or comparative effectiveness studies is not provided in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

November 2, 2018

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

Re: K182596

Trade/Device Name: Xario200G and Xario100G, Software V1.1 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 18, 2018 Received: September 20, 2018

Dear Orlando Tadeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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Indications for Use

510(k) Number (if known)

K182596

Device Name

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

Indications for Use (Describe)

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

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Transducer:

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal	N	N	N		N	2	N	N	N		N	4,5,6,7,8,9,11,12
Abdominal	N	N	N	N	N	2,3	N	N	N		N	4,5,6,7,8,9,11,12,14
Intra-operative (Abdominal)	N	N	N		N	2	N	N	N			5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic	N	N	N		N	2	N	N	N			5,7
Pediatric	N	N	N	N	N	2,3	N	N	N		N	4,5,6,7,8,9,11,12
Small Organ (Note 1)	N	N	N		N	2	N	N	N			4,5,6,7,8,9,10,11,12
Neonatal Cephalic	N	N	N	N	N	2,3	N	N	N			5,6,7,8,11
Adult Cephalic	N	N	N	N	N	3	N	N	N			7
Trans-rectal	N	N	N		N	2	N	N	N		N	4,5,6,7,8,9,12
Trans-vaginal	N	N	N		N	2	N	N	N		N	4,5,6,7,8,9,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	N	N	N		N	2	N	N	N			4,5,6,7,8,9,10,11,12
Musculo-skeletal (Superficial)	N	N	N		N	2	N	N	N			4,5,6,7,8,9,10,11,12
Intravascular
Other (Specify)
Cardiac Adult	N	N	N	N	N	3	N	N	N			4, 7, 13
Cardiac Pediatric	N	N	N	N	N	3	N	N	N			4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	N	N	N	N	N	3	N					4, 7, 13
Intra-cardiac
Other (Specify)
Peripheral vessel	N	N	N	N	N	2	N	N	N			4,5,6,7,8,9,10,11,12
Other (Specify)

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

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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Transducer: __ PSU-25BT

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P	7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P	7
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P	7
Adult Cephalic	P	P	P	P	P	3	P	P	P	7
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	4, 7, 13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking Note 14 Shear Wave

{5}------------------------------------------------

Transducer: __ PSU-30BT

		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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P			7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P			7
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P			7
Adult Cephalic	P	P	P	P	P	3	P	P	P			7
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			4, 7, 13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking Note 14 Shear Wave

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Transducer: PSU-50BT

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P	7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P	7
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P	7
Adult Cephalic	P	P	P	P	P	3	P	P	P	7
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	4, 7, 13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking Note 14 Shear Wave

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

Transducer: __ PSU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P			7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P			7
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P			7
Adult Cephalic	P	P	P	P	P	3	P	P	P			7
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			4, 7, 13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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System: __Xario200G and Xario100G, Software V1.1 Transducer: _ PVU-375BT

			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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P			4,5,6,7,8,9,11,12
Abdominal	P	P	P		P	2	P	P	P			4,5,6,7,8,9,11,12,1-
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P			4,5,6,7,8,9,11,12
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI

Note 5 ApliPure

Note 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI Note 9 Elastography

Note 9 Elastograp
No. 10 BEAM

Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

Note 13 2D Wall Motion Tracking

Note 14 Shear Wave

{9}------------------------------------------------

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-382BT

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Abdominal	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P			5,6,7,8,11,12
Abdominal	P	P	P		P	2	P	P	P			5,6,7,8,11,12
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,11,12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: PVU-674MV

Transducer. F V U-074MV

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P	P	5,6,7,8
Abdominal	P	P	P	P	2	P	P	P	P	5,6,7,8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	P	5,6,7,8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

Transducer: PVU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTF

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTH

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,6,7,8,11
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTV

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: PVU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	2	P	P	P	P	P	5,6,7,8,12
Trans-vaginal	P	P	P		P	2	P	P	P	P	P	5,6,7,8,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-770ST

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	2	P	P	P			4,5,6,7,8,9
Trans-vaginal	P	P	P		P	2	P	P	P			4,5,6,7,8,9
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,12
Trans-vaginal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	2	P	P	P			4,5,6,7,8,9,12
Trans-vaginal	P	P	P		P	2	P	P	P			4,5,6,7,8,9,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer: PVL-715RS

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P				5,6,7,8,12
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer:_ PLU-704BT

Transducer. FLU-704D1

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			5,6,7,8,10,11,12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	P	2	P	P	P			5,6,7,8,10,11,12
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P			5,6,7,8,10,11,12
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P			5,6,7,8,10,11,12
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure

Note 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

Note 13 2D Wall Motion Tracking

Note 14 Shear Wave

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

Transducer:_ PLU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11,1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11,1
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11,1
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			4,5,6,7,8,9,10,11,1
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

Transducer: PLU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,11,12
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			4,5,6,7,8,9,11,12
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,11,12
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			4,5,6,7,8,9,11,12
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

Transducer: PLU-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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,12
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,1
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,12
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking

Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 Transducer:

PET-512MC

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	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					4, 7, 13
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario200G and Xario100G, Software V1.1 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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	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					4, 7, 13
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

Transducer:_ PET-805LA

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	ColorDoppler	Combined(Specify) *	THI	DynamicFlow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic	P	P	P		P	2	P	P	P			5,7
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

Transducer: PC-20M

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	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				P
Cardiac Pediatric				P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel				P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

Transducer: PC-50M

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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	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												P
Cardiac Pediatric												P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel												P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276

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 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking Note 14 Shear Wave

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

MEDICAL SYSTEMS USA, INC.

K182596

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, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

5. DATE PREPARED:

September 7, 2018

6. DEVICE NAME:

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

7. TRADE NAME(S):

Diagnostic Ultrasound System Xario200G Model CUS-X200G Diagnostic Ultrasound System Xario100G Model CUS-X100G

8. COMMON NAME:

System, Diagnostic Ultrasound

PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780

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

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
Xario 200 DiagnosticUltrasound System V6.0	Canon MedicalSystems USA, Inc	K172276	December 12, 2017

11. REASON FOR SUBMISSION:

New device

12. DEVICE DESCRIPTION:

13. INDICATIONS FOR USE:

The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G 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), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

14. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Xario200 V6.0 Diagnostic Ultrasound System, 510(k) cleared under K172276, marketed by Canon Medical Systems USA, Inc. The Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System functions in a manner similar to and is intended for the same use as the predicate devices referenced within this submission. The subject device is a compact diagnostic ultrasound system that implements the latest technologies.

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

	Xario200G/Xario100GModel CUS-X200GModel CUS-X100G, v1.1	Xario200Model TUS-X200 v6.0	Comments
510(K) Control Number	This Submission (Subject)	K172276
Scanning Method	Electronic Convex,Electronic Sector,ElectronicLinear/Trapezoid, Pencil	Electronic Convex,Electronic Sector,ElectronicLinear/Trapezoid, Pencil	Same
Probe Selector	A/B/C Channels3 connections and Pencil	A/B/C Channels3 connections and Pencil	Same
	Xario200G/Xario100GModel CUS-X200GModel CUS-X100G, v1.1	Xario200Model TUS-X200 v6.0	Comments
B-Mode Depth	1cm (min.), 40 cm (max.)	1cm (min.), 40 cm (max.)	Same
Transmission/ReceptionCircuitry
Beam Formation ControlProcessing	DigitalParallel processing	DigitalParallel processing	Same
Summation	Quad Processing	Quad Processing	Same
Maximum TransmissionChannels	128 Channels (Xario200G)64 Channels (Xario100G)	128 Channels	Same forXario200G
Transmission Frequency	Multiple frequencies areselectable	Multiple frequencies areselectable	Same
Observation Monitor	21.5-inch LCD(LED backlight)	19-inch LCD(LED backlight)	Change
Reference signal: ECGWired	Yes	Yes	Same
Wireless	Yes (Xario200G) / No(Xario100G)	No	Change
Foot switchWired	Yes	Yes	Same
Wireless	Yes (Xario200G) / No(Xario100G)	No	Change
Battery pack	Yes	No	Change
Mounting kit for Batterypack	Yes (Xario200G) / No(Xario100G)	No	Change

15. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004 Output Display and ISO 10993-1 standards.

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

16. TESTING

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

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 Xario200G/Xario100G systems.

17. CONCLUSION

The Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System 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.

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

System: __Xario200G and Xario100G, Software V1.1 Transducer: _ PVU-375BT

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-382BT

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-674BT

System: __Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-674MV

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTF

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTH

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTV

System: Xario200G and Xario100G, Software V1.1 Transducer: PVU-681MVL

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-770ST

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-781VT

System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-781VTE

System: Xario200G and Xario100G, Software V1.1 Transducer: PVL-715RS

System: Xario200G and Xario100G, Software V1.1 Transducer:_ PLU-704BT

System: Xario200G and Xario100G, Software V1.1 Transducer:

System: Xario200G and Xario100G, Software V1.1 Transducer: PET-512MD

MEDICAL SYSTEMS USA, INC.

510(k) SUMMARY

4. CONTACT PERSON:

5. DATE PREPARED:

6. DEVICE NAME:

7. TRADE NAME(S):

8. COMMON NAME:

9. DEVICE CLASSIFICATION:

Class II

10. PREDICATE DEVICE:

11. REASON FOR SUBMISSION:

12. DEVICE DESCRIPTION:

13. INDICATIONS FOR USE:

14. SUBSTANTIAL EQUIVALENCE:

15. SAFETY:

16. TESTING

17. CONCLUSION

§ 892.1550 Ultrasonic pulsed doppler imaging system.

System: Xario200G and Xario100G, Software V1.1 Transducer: PVU-674MV