Predicate Devices

Reference Devices

ALOKA LISENDO 880 (K162583), Noblus (K160559), HI VISION Ascendus (K153421)

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging techniques and digital signal processing (adaptive filters) but does not mention AI or ML.

Therapeutic

No
The device is described as a "multi-functional ultrasound diagnostic scanner" intended for "diagnostic ultrasound evaluation," indicating its use for diagnosis rather than therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic ultrasound evaluation." Additionally, the "Device Description" refers to it as a "multi-functional ultrasound diagnostic scanner."

SaMD (Software as a Medical Device)

No

The device description clearly 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 essential for generating and receiving ultrasound waves.

IVD (In Vitro Diagnostic)

Based on the provided information, the ALOKA ARIETTA 850 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
ALOKA ARIETTA 850 Function: The description clearly states that the ALOKA ARIETTA 850 is an ultrasound diagnostic scanner. Ultrasound technology uses sound waves to create images of internal body structures. This is a form of in vivo (within the living body) diagnostic imaging.
Intended Use: The intended use lists various clinical applications for diagnostic ultrasound evaluation of different anatomical sites and patient populations. This aligns with the use of an ultrasound machine for imaging, not for testing samples.

Therefore, the ALOKA ARIETTA 850 is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), and Peripheral vessel clinical applications.

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

Product codes

IYN, IYO, ITX

Device Description

The ALOKA ARIETTA 850 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 ALOKA ARIETTA 850 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 image 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 beam 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

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral Vessel. Additional listed sites under "Additional Comments" for specific transducers include: Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). Includes thyroid, parathyroid, breast, scrotum, and penis. Includes imaging for guidance of trans-rectal biopsy. Includes imaging for guidance of trans-vaginal biopsy. Includes imaging for Cavernous/Non-Cavernous wounds.

Indicated Patient Age Range

Fetal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric. For adult and pediatric patients (Trans-esophageal (non-Card.), Trans-esophageal (Adult/Pediatric)).

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: Hitachi judged that ALOKA ARIETTA 850 is substantially equivalent to the predicate.
Performance Testing - Clinical: None required.
The analysis confirms the performance characteristics of the ALOKA ARIETTA 850 are comparable to the predicate device and support our conclusion that the subject device is substantially equivalent.

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

Not Found

Predicate Device(s)

ARIETTA 70 (K134016)

Reference Device(s)

ALOKA LISENDO 880 (K162583), Noblus (K160559), HI VISION Ascendus (K153421)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Hitachi Healthcare Americas Corporation % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087

October 31, 2017

Re: K171708

Trade/Device Name: ALOKA ARIETTA 850 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 24, 2017 Received: October 25, 2017

Dear Mr. Thistlethwaite:

This letter corrects our substantially equivalent letter of October 31, 2017.

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

Page 2 - Mr. Doug Thistlethwaite

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jeff Balygo

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

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171708

Device Name ALOKA ARIETTA 850

Indications for Use (Describe)

The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), and Peripheral vessel clinical applications.

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Pert 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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3

Device Name: ALOKA ARIETTA 850

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

	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	P
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	P	P	P	P	P	P	P
	Trans-rectal	Pe	Pe	Pe	Pe	Pe	Pe	Pe
	Trans-vaginal	Pf	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	P
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	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	P	P
	Other (spec.)

N = new indication; P = previously cleared in K134016, K160559 and K153421

*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). Tissue Dopler Imaging, Free Angular M-mode, 3D Imaging, Shear Wave Measurement

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.

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

4

Device Name: ALOKA ARIETTA 850 Transducer: C22K 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
	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in 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, 3D 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":

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: ALOKA ARIETTA 850
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*
(Spec.)	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
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K160559

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

Power Doppler (Color Flow Angiography), Free Angular M-mode, 3D image

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":
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: ALOKA ARIETTA 850 Transducer: C251 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	P
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K1162583

*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), Tissue Dopler Imaging, Free Angular M-mode, 3D imaging, Shear Wave Measurement

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":
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

7

Device Name: ALOKA ARIETTA 850
Transducer: C252
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD
	Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P	P	P	P	P
	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	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K162583

*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), Tissue Doppler Imaging, Free Angular M-mode, 3D imaging

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

8

Device Name: ALOKA ARIETTA 850 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*
(Spec.)	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
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

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":

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

9

Device Name: ALOKA ARIETTA 850 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*
(Spec.)	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 K162583

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, CMM-B/CW

**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, 3D 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.

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

10

Device Name: ALOKA ARIETTA 850 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*
(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)	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 K160559

*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 amnocentesis).

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.

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

11

Device Name: ALOKA ARIETTA 850 Transducer: C42K 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.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K162583

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

**Power Doppler (Color Flow Angiography), Free Angular M-mode, 3D 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.

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: ALOKA ARIETTA 850 Transducer: CC41R1 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
	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K160559

*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 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.

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: ALOKA ARIETTA 850 Transducer: CL4416R 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
	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	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K160559

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

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

Device Name: ALOKA ARIETTA 850 Transducer: L34 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.)
	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.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P
Vessel	Other (spec.)

N = new indication; P = previously cleared in K162583

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, 3D 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.

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: ALOKA ARIETTA 850 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*
(Spec.)	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	Cardiac Adult
		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 K162583

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, 3D 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.

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

16

Device Name: ALOKA ARIETTA 850 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*
(Spec.)	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		Cardiac Adult
		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 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, 3D 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.

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

17

Device Name: ALOKA ARIETTA 850 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*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	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	Cardiac Adult
	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 K162583

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, 3D 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.

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

18

Device Name: ALOKA ARIETTA 850 Transducer: MXS1 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	P
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
	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 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
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K162583

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), Tissue Doppler Imaging, Free Angular M-mode, 3D 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":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

19

Device Name: ALOKA ARIETTA 850 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 K160559

*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)

Additional Comments:

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

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.

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: ALOKA ARIETTA 850 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
Fetal Imaging
& Other	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in 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)

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":

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

21

Device Name: ALOKA ARIETTA 850 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*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
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
	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 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
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K162583

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), Tissue Doppler Imaging, 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.

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

22

Device Name: ALOKA ARIETTA 850 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*
(Spec.)	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	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
	Other (spec.)

N = new indication; P = previously cleared in K162583

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), Tissue Doppler Imaging, 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.

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

23

Device Name: ALOKA ARIETTA 850 Transducer: S3ESEL 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
	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 Adult
Cardiac	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 K162583

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), Tissue Doppler Imaging, Free Angular M-mode

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.

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

24

Device Name: ALOKA ARIETTA 850 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*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	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 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), Tissue Doppler Imaging, 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.

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

25

Device Name: ALOKA ARIETTA 850 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*
(Spec.)	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
Vessel	Peripheral vessel
Peripheral
Vessel	Other (spec.)

N = new indication; P = previously cleared in K162583

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), Tissue Doppler Imaging, Free Angular M-mode

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.

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

26

Device Name: ALOKA ARIETTA 850 Transducer: SML44 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	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.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	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
	Other (spec.)

N = new indication; P = previously cleared in 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, 3D 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.

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

27

Device Name: ALOKA ARIETTA 850 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
Fetal Imaging
& Other	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	Peripheral vessel			P
Vessel	Other (spec.)

N = new indication; P = previously cleared in K162583

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

28

Device Name: ALOKA ARIETTA 850 Transducer: UST-2266-5 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
	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
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel				P
Vessel	Other (spec.)

N = new indication; P = previously cleared in K162583

**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, 3D 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.

Subscript "g": For Adult and pediatric patients

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

29

Device Name: ALOKA ARIETTA 850 Transducer: VC34 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	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 Adult
Cardiac	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 "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)

30

Submitter Information

| Submitter: | Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371 |
|-------------------|----------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Telephone number: | 330-425-1313 |
| Telephone number: | 330-963-0749 |
| E-mail: | thistlethwaited@hitachihealthcare.com |
| Date: | April 18, 2017 |

Subject Device Name

Trade/Proprietary Name:	ALOKA ARIETTA 850
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

Main Predicate Device:	ARIETTA 70 (K134016)
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	ALOKA LISENDO 880 (K162583) Noblus (K160559) HI VISION Ascendus (K153421)

Device Intended Use

The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), and 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, and 4D Imaging.

31

Device Description

Function

The ALOKA ARIETTA 850 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 ALOKA ARIETTA 850 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 image 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 beam 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.

32

Scientific Concepts

The principle of operation of ultrasound imaging involves generation of an ultrasound wave pulses with an electric signal applied to a transducer, direction of the resulting ultrasound wave into the tissue of the body, and reception and analysis of the echoes reflected back to the same or an adjacent transducer from the various tissues along the path of the ultrasound wave. The ultrasound waves comprising a beam travel in as straight line in homogeneous media. When an ultrasound wave reaches an interface between two media of different impedances, a portion of the beam energy may pass through the boundary (transmission), and a portion may be reflected. The direction of propagation of the transmitted beam is determined by the angle of incidence of the incident beam upon the boundary, and differences (if any) in the speed of sound in the two media. The direction of reflection is determined solely by the angle of incidence upon the boundary. The relative strength of the reflected wave depends upon the differences in the impedances between the two media. Reflection at a boundary between soft tissue and bone, as an example, involves a large impedance difference, and results in a relatively strong reflected echo. Reflection at a boundary between two soft tissue-types with a relatively small impedance difference, on the other hand, results in a relatively weak reflected echoed. The workstation is based on current PC technology using the Windows™ operating system.

Physical and Performance Characteristics

Analysis confirms the performance characteristics of the ALOKA ARIETTA 850 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 ALOKA ARIETTA 850. 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 ALOKA ARIETTA 850 is substantially equivalent to the predicate.
Performance Testing - Clinical	None required

The analysis confirms the performance characteristics of the ALOKA ARIETTA 850 are comparable to the predicate device and support our conclusion that the subject device is substantially equivalent

33

Device Technological Characteristics

The technological characteristics differences between the ALOKA ARIETTA 850 and the predicate device ARIETTA 70 (K134016) are:

Physical characteristics of the system ●	There are differences in appearance, weight, size, and hardware from the predicate device.
	ALOKA ARIETTA 850
Image: ALOKA ARIETTA 850
Predicate Device
Image: Predicate Device
●	Body Motion Tracking Feature	The Body Motion Tracking is an additional function to Real-time Virtual
Sonography (RVS) software. It consists of a magnetic sensor manufactured by
Hitachi and a omniTrax bracket manufactured by CIVCO (K143396).
The Body Motion Tracking facilitates automatic registration of fused images
when used at the time of CT/MR image acquisition; with the synchronized
status being updated when small movements in the patient position are
detected during the RVS examination.
●	Needle Tracking Feature	The Needle Tracking is an additional function to Real-time Virtual Sonography
(RVS) software. It consists of a magnetic sensor manufactured by Hitachi and a
VirtuTrax bracket manufactured by CIVCO (092619).
The Needle Tracking function can track and display the needle tip location on
an ultrasound image.
●	Volume Data Extension Feature	The Volume Data Extension is a function which imports and displays parts
regions (ex. liver, blood vessel and tumor). The regions are extracted from CT
images in advance and displayed on the images as easily viewable color
regions. A data format of the parts regions includes pairs of part index and pixel
positions.
●	3D Sim-Navigator Feature	3D Sim-Navigator is an additional function to Real-time Virtual Sonography
(RVS) software which helps to simulate puncture and plan the layout of multiple
needles three dimensionally.
●	E-field Simulator Feature	The E-field Simulator is an additional function to 3D Sim-Navigator function.
The E-field Simulator calculates the electric field (based on the position of the
electrodes of the RFA treatment device being used in combination with RVS),
and displays it on the virtual sonography image (CT/MR image) as an E-Field
image

34

| • | Automated FHR Measurement Feature | In B mode, specifies a measurement ROI on the tomographic image of the fetal
heart to measure heart rate automatically from continuous frames | | | | | | | | | | | | |
|---|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| • | Additional new probes (CC41R1, CL4416R, SML44) | New Probe Predicate Probe Predicate/Reference System CC41R1 CC41R K160559 (Noblus) CL4416R C41L47RP K160559 (Noblus) SML44 L64 K160559 (Noblus) | | | | | | | | | | | | |

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.

Item	Overall Rationale Analysis
System Configuration	Based on that there are no significant differences in size, weight, connections, and
Track from the predicate device, Hitachi judges that the ALOKA ARIETTA 850 has no
additional issues with safety and effectiveness.
Probes	Based on that there are no significant differences from the predicate device and all
probes have been cleared 510(k) in the previous submissions, Hitachi judges that the
ALOKA ARIETTA 850 has no additional issues with safety and effectiveness.
Transmit/Receive
Parameters	Based on that there are no significant differences from the predicate device, Hitachi
judges that the ALOKA ARIETTA 850 has no additional issues with safety and
effectiveness.
Modes of Operation	Based on that there are no significant differences from the predicate device, Hitachi
judges that the ALOKA ARIETTA 850 has no additional issues with safety and
effectiveness.
Features (All)	Based on that there are no significant differences from the predicate device, Hitachi
judges that the ALOKA ARIETTA 850 has no additional issues with safety and
effectiveness.

Based on analysis of the above-mentioned comparison, Hitachi has judged this device to have the equivalent safety and effectiveness of the predicate device, ARIETTA 70 (K134016).

35

Summary of Non-Clinical Testing

The ALOKA ARIETTA 850 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 o 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 2.0 2007 .
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 3: 2007-03
Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic 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 | ANSI | ISO | 0993-10:20IO/(R)2014 ●

Biological evaluation of medical devices - part I 0: tests for irritation and skin sensitization. (Biocompatibility)

NEMA UD 2-2004 (R2009)
Acoustic output measurement standard for diagnostic ultrasound equipment - revision 3. Radiology)
NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2

Summary of Clinical Testing

Clinical testing was not required.

Conclusions

It is the opinion of Hitachi, Ltd. that the ALOKA ARIETTA 850 ultrasound diagnostic scanner and transducers are substantially equivalent to the predicate device. The subject device software features, intended use, materials, and diagnostic capabilities have been taken from the predicate device. In addition, we have concluded that the subject device and predicate device is substantially equivalent with respect to safety, effectiveness, and functionality