Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and processing techniques (like adaptive filters) but does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for such algorithms.

Therapeutic

No
The device is described as a "diagnostic ultrasound scanner" for "diagnostic ultrasound evaluation," and its modes of operation are for creating images (B mode, M mode, Doppler, 3D/4D imaging), not for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "The ARIETTA 750 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of..." a variety of clinical applications. Additionally, the "Device Description" introduces the ARIETTA 750 as a "multi-functional ultrasound diagnostic scanner."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-functional ultrasound diagnostic scanner" and mentions the use of "linear, convex, radial and phased array scan type probes," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the ARIETTA 750 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
ARIETTA 750 Function: The ARIETTA 750 is an ultrasound diagnostic scanner. It uses sound waves to create images of internal structures within the human body. This is an in vivo (within the living body) diagnostic method.
Intended Use: The intended use clearly states it's for "diagnostic ultrasound evaluation" of various anatomical sites and clinical applications, all of which involve imaging the patient directly.
Device Description: The description details how the device generates and receives ultrasound beams to form images, which is consistent with an in vivo imaging device.

Therefore, the ARIETTA 750 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ARIETTA 750 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel clinical applications.

The Modes of Operation are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

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

IYN, IYO, ITX

Device Description

The ARIETTA 750 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.

The ARIETTA 750 can be used for individual or combined display in the image display model listed below.

B mode is a display mode in which the tomographic imaqe is formed with plural ● ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
M mode is a display mode of ultrasound beams received sequentially and repeatedly on ● the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. ● PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.

The 5 methods of electronic scanning are as follows.

Linear Scanning Method: .
By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject.
. Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.
Sector Scanning Method:

By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.

. Radial Scanning Method:
By this method, the ultrasound probe emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject.
. Trapezoidal Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel

Indicated Patient Age Range

Adult, pediatric, neonatal, fetal

Intended User / Care Setting

trained personnel (doctor, Sonographer, etc.)

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)

Performance Testing - Bench, Clinical testing was not required

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.

K183456

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.

K134016, K181376, K142618

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

August 9, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Hitachi Healthcare Americas % Aaron Pierce Director, RA/QA 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K191233

Trade/Device Name: ARIETTA 750 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 11, 2019 Received: June 12, 2019

Dear Aaron Pierce:

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/cfpmp/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 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

1

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

For

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

Enclosure

2

Indications for Use

510(k) Number (if known) K191233

Device Name ARIETTA 750 Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

Indications for Use (Describe)

The ARIETTA 750 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel clinical applications.

The Modes of Operation are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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3

Device Name: ARIETTA 750

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

Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
Fetal Imaging
& Other	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)	P	P	P		P	P	P
	Laparoscopic	P	P	P		P	P	P
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd	Pd	Pd	Pd	Pd
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Musculo-skel. (Convent.)	P	P	P	P	P	P	P
	Musculo-skel. (Superfic.)	P	P	P	P	P	P	P
	Intra-luminal
	Other (Wound)	Ph	Ph	Ph	Ph	Ph	Ph	Ph
	Other (Gynecological)	P	P	P		P	P	P
	Cardiac Adult	P	P	P		P	P	P
Cardiac	Cardiac Pediatric	P	P	P		P		P
	Trans-esophageal (Adult/Pediatric)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P		P	P		P
	Other (spec.)

N = new indication; P = previously cleared in K173739, K160559

*Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

** Power Dopler (Color Flow Angiography), Free Angular M-mode, Tissue Dopler Imaging, Shear Wave Measurement, Real time 3D Imaging, 4D Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Includes imaging for guidance of trans-rectal biopsy Subscript "e":

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

4

Device Name: ARIETTA 750 Transducer: C252 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Clinical Mode of Operation | | | | | |---------------------------|-------------- | General
(Track I only) | Specific
(Tracks I & III) | B Doppler | Combined*
(Spe | Other**
(Spec.) |
| Ophthalmic | Ophthalmic | | Fetal | Fetal Imaging | Abdominal | & Other | | | Intra-operative (Neuro.) | | Laparoscopic | | Pediatric | | Small Organ (Spec.) | | Neonatal Cephalic | | Adult Cephalic | | Trans-rectal | | Trans-vaginal | | Trans-urethral | | Trans-esoph. (non-Card.) | | Musculo-skel. (Convent.) | | Musculo-skel. (Superfic.) | | Intra-luminal | | Other (Wound) | | Other (Gynecological) | | Cardiac Adult | Cardiac | Cardiac Pediatric | | Trans-esophageal | | Other (spec.) | Peripheral | Peripheral vessel | Vessel | Other (spec.) Application
| | |
-----------------------------|----|----|-----|-----|------------------|-------------------|--------------------|
| M | PWD | CWD | Color
| | | | | | | |
| P | P | P | P | P | P | P |
| Pa | Pa | Pa | Pa | Pa | Pa | Pa |
Intra-operative (Spec.) | | | | | | | |
| | | | | | | |
| | | | | | | |
| P | b | P | P | P | P | b |
| bd | Pd | Pd | bd | bd | bd | Pd |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
(Adult/Pediatric) | | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

** Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging, Shear Wave Measurement

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

5

Device Name: ARIETTA 750

Transducer: C253

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

| | Clinical Application
Mode of Operation | | | | | | | |
|---------------------------|-------------------------------------------|----|----|-----|-----|------------------|-------------------|--------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spe | Other**
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| Fetal Imaging
& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/W B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging, Shear Wave Measurement

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Includes imaging of organs and structures exposed during surgery Subscript "b":

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

6

Device Name: ARIETTA 750

Transducer: C35

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

	Clinical Application					Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	b	P	P	b	P
Fetal Imaging
& Other	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	bd	Pd	bd	bd	bd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging
Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Includes imaging for guidance of trans-rectal biopsy Subscript "e":

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

7

Device Name: ARIETTA 750 Transducer: C22P Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
Fetal Imaging
& Other	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery
- (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

8

Device Name: ARIETTA 750 Transducer: C25P Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
Fetal Imaging
& Other	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

For Adult and pediatric patients Subscript "g":

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

9

Device Name: ARIETTA 750 Transducer: C41V1 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)	P	P	P		P	P	P
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

10

Device Name: ARIETTA 750 Transducer: C41B Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)	P	P	P		P	P	P
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode,

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

For Adult and pediatric patients Subscript "g":

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

11

Device Name: ARIETTA 750

Transducer: C42

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

	Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)	Pb	Pb	Pb	Pb	Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd	Pd	Pd	Pd	Pd
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K134016

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

12

Device Name: ARIETTA 750 Transducer: L441 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd	Pd	Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P	P	P	P	P
	Musculo-skel. (Superfic.)	P	P	P	P	P	P	P
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

13

Device Name: ARIETTA 750 Transducer: L442 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Clinical Application
Mode of Operation | | | | | | | |
|---------------------------|-------------------------------------------|----|----|-----|-----|------------------|-------------------|--------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spe | Other**
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging
& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (spec.) | | | | | | | |

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

14

	Clinical Application					Mode of Operation
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
	Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	Fetal
		Abdominal
		Intra-operative (Spec.)	Pb	Pb	Pb	Pb	Pb	Pb
		Intra-operative (Neuro.)
		Laparoscopic
		Pediatric
		Small Organ (Spec.)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skel. (Convent.)
		Musculo-skel. (Superfic.)
		Intra-luminal
		Other (Wound)
		Other (Gynecological)
Cardiac	Cardiac Adult	Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (Adult/Pediatric)
		Other (spec.)
Peripheral
Vessel	Peripheral vessel	Peripheral vessel
		Other (spec.)

Device Name: ARIETTA 750 Transducer: L53K

Other (spec.) N = new indication; P = previously cleared in K173739

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "'d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

15

Device Name: ARIETTA 750 Transducer: L55

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Wound)	Ph	Ph	Ph		Ph	Ph	Ph
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging

Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

16

Device Name: ARIETTA 750 Transducer: L64 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd	Pd	Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P	P	P	P	P
	Musculo-skel. (Superfic.)	P	P	P	P	P	P	P
	Intra-luminal
	Other (Wound)	Ph	Ph	Ph	Ph	Ph	Ph	Ph
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/W B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Shear Wave Measurement

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

17

Device Name: ARIETTA 750 Transducer: R41R Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K134016

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography)

Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

For Adult and pediatric patients Subscript "g":

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

18

Device Name: ARIETTA 750 Transducer: R41RL Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K134016

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography)

Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

For Adult and pediatric patients Subscript "g":

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

19

Device Name: ARIETTA 750

Transducer: S11

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P	P	P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/W B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

20

Device Name: ARIETTA 750 Transducer: S121 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P	P	P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Includes imaging for guidance of trans-rectal biopsy Subscript "e":

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

21

Device Name: ARIETTA 750

Transducer: S31

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

	Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging
Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

22

Device Name: ARIETTA 750 Transducer: S42 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging

Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Includes imaging for guidance of trans-rectal biopsy Subscript "e":

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

23

Device Name: ARIETTA 750 Transducer: S3ESL1 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K173739, K160559

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging

Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":

24

Device Name: ARIETTA 750 Transducer: CC41R Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application		Mode of Operation
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
	Ophthalmic	Ophthalmic
	Fetal Imaging
& Other	Fetal	P	P	P		P	P	P
		Abdominal
		Intra-operative (Spec.)
		Intra-operative (Neuro.)
		Laparoscopic
		Pediatric
		Small Organ (Spec.)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
		Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skel. (Convent.)
		Musculo-skel. (Superfic.)
		Intra-luminal
		Other (Wound)
		Other (Gynecological)
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (Adult/Pediatric)
		Other (spec.)
	Peripheral
Vessel	Peripheral vessel
		Other (spec.)

N = new indication; P = previously cleared in K134016

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

25

Device Name: ARIETTA 750 Transducer: C41L47RP Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spe	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K173739, K160559

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

For Adult and pediatric patients Subscript "g":

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

26

Device Name: ARIETTA 750 Transducer: VC35 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
Fetal Imaging
& Other	Abdominal	P	P	P		P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc		Pc	Pc	Pc
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
		Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K134016

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging, 4D Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

For Adult and pediatric patients Subscript "g":

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

27

Device Name: ARIETTA 750 Transducer: VC41V Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)	P	P	P		P	P	P
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K134016

*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, 3D Imaging, 4D Imaging

Additional Comments:

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

For Adult and pediatric patients Subscript "g":

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

28

Device Name: ARIETTA 750 Transducer: UST-2265-2 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				P
	Other (spec.)

N = new indication; P = previously cleared in K173739, K181376

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery

(excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "'d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

Prescription Use Only (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K191233

29

K191233

Section 5 510(k) Summary

Submitter Information

| Submitter: | Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371 |
|-------------------|----------------------------------------------------------------------------------------|
| Contact: | Aaron Pierce |
| Telephone number: | 330-425-1313 |
| Telephone number: | 330-963-0749 |
| E-mail: | piercea@hitachihealthcare.com |
| Date: | January 18, 2019 |

Subject Device Name

Trade/Proprietary Name:	ARIETTA 750
Regulation Number:	21 CFR 892.1550
Regulation Name:	Diagnostic Ultrasound System and Accessories
Product Code	90-IYN, 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System
90-IYO, 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System
90-ITX, 21 CFR 892.1570 Diagnostic Ultrasonic Transducer
Class	II
Panel	Radiology

Predicate Device Name

Predicate Device(s):	ALOKA ARIETTA 850 (K183456)
Regulation Number:	21 CFR 892.1550
Regulation Name:	Diagnostic Ultrasound System and Accessories
Product Code	90-IYN, 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System
90-IYO, 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System
90-ITX, 21 CFR 892.1570 Diagnostic Ultrasonic Transducer
Class	II
Panel	Radiology
Reference Devices	• ARIETTA 70 Diagnostic Ultrasound Scanner (K134016)
• ARIETTA 65 Diagnostic Ultrasound Scanner (K181376)
• Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7
Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System (K142618)

Indications for Use

The ARIETTA 750 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel clinical applications.

The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

30

Device Description

Function

The ARIETTA 750 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.

The ARIETTA 750 can be used for individual or combined display in the image display model listed below.

B mode is a display mode in which the tomographic imaqe is formed with plural ● ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
M mode is a display mode of ultrasound beams received sequentially and repeatedly on ● the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. ● PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.

The 5 methods of electronic scanning are as follows.

Linear Scanning Method: .
By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject.
. Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.
Sector Scanning Method:

By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.

. Radial Scanning Method:
By this method, the ultrasound probe emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject.
. Trapezoidal Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.

31

Image /page/31/Picture/0 description: The image shows the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font, also in black.

Scientific Concepts

The principle of operation of ultrasound imaging involves a number of transducers of multiple available transducers form a block that almost simultaneously transmit and receive ultrasound waves. The ultrasound waves generated by each transducer combine to form one ultrasound wave with the same effect as a single ultrasound beam emitted from the center of these transducers. When the first beam has been sent and received, transducers adjacent to the transducers in the first block start sending and receiving ultrasound waves to form the second ultrasound beam. The center of the second ultrasound beam is shifted from the center of the first ultrasound by one transducer. In this manner, different blocks of transducers are used each time to create multiple ultrasound beams with a slightly different center and form a scan plane. Also, the beams can be focused together by adding a time difference to the transmission and reception that creates the beams, to join them in an acoustic focus. Continuously setting the focal time difference according to the ultrasonic wave arrival time can obtain a beam that is joined in overall focus.

This instrument can also revise the time difference between ultrasonic waves that arrive at different times due to different speeds within the patient or diagnostic region.

The ultrasound beams obtained as explained above are converted to video signals with the digital scanning converter, and are displayed on the viewing monitor.

Physical and Performance Characteristics

Analysis confirms the performance characteristics of the ARIETTA 750 are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent.

Performance Comparison

No new hazards were identified with the ARIETTA 750. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.

Testing Type	Rationale Analysis
Performance Testing - Bench	Hitachi judged that ARIETTA 750 is substantially equivalent to the predicate.
Performance Testing - Clinical	None required

The analysis confirms the performance characteristics of the ARIETTA 750 are comparable to the predicate device and support our conclusion that the subject device is substantially equivalent.

32

Image /page/32/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font, also in black. The logo is simple and modern, with a focus on the company name and its message.

Device Technological Characteristics

The technological characteristics differences between the ARIETTA 750 and the predicate device ALOKA ARIETTA 850 (K183456) are:

• Physical characteristics of the system	There are no significant differences in appearance, weight, size, hardware, transmit/receive parameters, modes of operation, and features from the predicate device.
	ARIETTA 750
Subject Device
Image: ARIETTA 750	ARIETTA 850
Predicate Device
Image: ARIETTA 850
• Probes	AVAILABLE PROBE	PREVIOUS CLEARANCE
	C22P	ALOKA ARIETTA 850 K173739
	C25P	ALOKA ARIETTA 850 K173739
	C252	ALOKA ARIETTA 850 K173739
	C253	ARIETTA 65 K181376
	C35	ALOKA ARIETTA 850 K173739
	C41V1	ALOKA ARIETTA 850 K173739
	C41B	ALOKA ARIETTA 850 K173739
	C42	NOBLUS K160559
	CC41R	NOBLUS K160559
	C41L47RP	NOBLUS K160559
	L441	ALOKA ARIETTA 850 K173739
	L442	ARIETTA 65 K181376
	L53K	ARIETTA Precision K163505
	L55	ALOKA ARIETTA 850 K173739
	L64	ALOKA ARIETTA 850 K173739
	R41R	ALOKA ARIETTA 850 K173739
	R41RL	ALOKA ARIETTA 850 K173739
	S11	ARIETTA 65 K181376
	S121	ALOKA ARIETTA 850 K173739
	S31	ALOKA ARIETTA 850 K173739
	S42	ALOKA ARIETTA 850 K173739
	S3ESL1	ALOKA ARIETTA 850 K173739
	VC35	ALOKA ARIETTA 850 K173739
	VC41V	ARIETTA 70 K134016

33

Image /page/33/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font, also in black. There is a small red accent mark above the letter 't' in the word 'Next'.

Substantial Equivalence

A summary decision was based on a thorough analysis and comparison of the functions. scientific concepts, physical and performance characteristics, performance comparison and technological characteristics.

System Configuration
01	Based on that there are no significant differences in size, weight, connections, and Track from the predicate device, Hitachi
judges that the ARIETTA 750 has no additional issues with safety and effectiveness.
Probes
02	The 25 probes for the system meet user requirements in regards to indications for use and have no effect on the safety and
effectiveness of the device. These probes have been cleared by previous 510(k) submissions. See Probe Comparison Chart
below.
Transmit/Receive Parameters
03	Based on that there are no significant differences from the predicate device, Hitachi judges that the ARIETTA 750 has no
additional issues with safety and effectiveness.
Modes of Operation
04	The ARIETTA 750 has no significant differences in the modes that are available on both systems. Therefore, Hitachi judges that
the ARIETTA 750 has no additional issues with safety and effectiveness.
Features
05	The ARIETTA 750 has no significant differences in the features that are available on both systems. Therefore, Hitachi judges that
the ARIETTA 750 has no additional issues with safety and effectiveness.

Based on analysis of the above-mentioned comparison, Hitachi has judged the subject device to have the equivalent safety and effectiveness of the predicate device.

Summary of Non-Clinical Testing

The ARIETTA 750 system is in conformance with the applicable parts of the following standards:

AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
. 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. (Radiology)
. IEC 60601-1-2 Edition 4.0 2014-02
Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromaqnetic compatibility - requirements and tests. (General II (ES/EMC))
AAMI I ANSI I ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - part I: evaluation and testing within a risk management process. (Biocompatibility)
AAMI I ANSI I ISO 10993-5:2009/(R)2014 ● Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity. (Biocompatibility)
AAMI I ANSI I ISO I 0993-10: 2002 + am1 2006 ● Biological evaluation of medical devices - part I 0: tests for irritation and skin sensitization. (Biocompatibility)

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Summary of Clinical Testing

Clinical testing was not required.

Conclusions

lt is the opinion of Hitachi, Ltd. that the ARIETTA 750 Ultrasound Diagnostic scanner and transducers is substantially equivalent to the predicate devices. The subject device software features, intended use, materials, and diagnostic capabilities have been taken from the predicate devices. In addition, we have concluded that the subject device and predicate devices are substantially equivalent with respect to safety, effectiveness, and functionality.