Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and technology mentions do not include any terms or concepts related to AI or ML.

Therapeutic

No
The device is described as an "ultrasound diagnostic system" intended for "diagnostic ultrasound" applications, not for therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound" of various clinical applications. Additionally, the "Device Description" section refers to it as an "ultrasound diagnostic system," and the "Predicate Device(s)" are identified as "Diagnostic Ultrasound Scanner" devices.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as ultrasound transducers, a computer system, and a video monitor, indicating it is a hardware-based medical device with integrated software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "diagnostic ultrasound" for various clinical applications and anatomical sites. This describes a device used to image the body from the outside or internally, not to analyze samples taken from the body.
Device Description: The description focuses on components related to generating and receiving ultrasound waves and processing the resulting signals to create images. This is characteristic of an ultrasound imaging system.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This ultrasound system does not perform that function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Hitachi Aloka Medical. Ltd. AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultration of Abdominal. Cardiac. Intra-operative. I ctal. Pediative. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal. Musculoskeletal. Neonatal Cephalic. Adult Cephalie, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The Modes of Operation are B mode. PW mode (Pulsed Wave Doppler). CW mode (Continuous Wave Doppler). Color Doppler. Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.

Product codes

90-IYN, 90-IYQ, 90-ITX

Device Description

An ultrasound diagnostic system with the following features:

Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes ṃ
Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation
o A computer system - to control the transducer and analyze the signals resulting from the reflected echocs
O A video monitor with optional image recorder - to display the computed image or derived Doppler data

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal. Cardiac. Intra-operative. I ctal. Pediative. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal. Musculoskeletal. Neonatal Cephalic. Adult Cephalie, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

Indicated Patient Age Range

Adult, Pediatric, Neonatal

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)

Non-clinical Testing: No new hazards were identified with the subject device and its transducers have been evaluated for acoustic output, biocompaibility, cleaning & disinfection effectiveness, clectromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
Clinical testing: None required

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

Not Found

Predicate Device(s)

K110673, K123828

Reference Device(s)

Not Found

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

Hitachi Aloka Medical, Ltd.

K134016
Page 1 of 3

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.

21 CFR 807.92. Subsection a

Submitter's Information

Hitachi Aloka Medical, Ltd. 10 Fairfield Boulevard Wallingford, CT 06492-5903

Contact: Angela Van Arsdale RA/QA Manager

Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075

Date Prepared: December 18, 2013

Device / Common / Classification Name / Classification / Product Code:

Device Proprietary Name - Arietta70 / AriettaV70 Diagnostic Ultrasound System Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic Classification: Class II Product Code: 90-IYN 892.1550 Ultrasonic Pulsed Imaging System 90-IYQ 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer

Legally Marketed Predicate Device(s):

Hitachi HI VISION Ascendus Diagnostic Ultrasound Scanner [K110673] Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]

4. Device Description:

An ultrasound diagnostic system with the following features:

Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes ಂ
Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation
o A computer system - to control the transducer and analyze the signals resulting from the reflected echocs
O A video monitor with optional image recorder - to display the computed image or derived Doppler data
1. Indication for Use:

The Hitachi Aloka Medical. Ltd. AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultration of Abdominal. Cardiac. Intra-operative. I ctal. Pediative. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal. Musculoskeletal. Neonatal Cephalic. Adult Cephalie, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The Modes of Operation are B mode. PW mode (Pulsed Wave Doppler). CW mode (Continuous Wave Doppler). Color Doppler. Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.

510(K) Premarket Notification - Arietta 70 / Arietta S70 / Arietta V70 Ultrasound Diagnostic System and Probes

1

Hitachi Aloka Medical, Ltd.

Comparison to predicate device:

The Hitachi Aloka Medical. Ltd. AriettaS70 / AriettaV70 Diagnostic Ultrasound device is technically comparable. and substantially equivalent to the HI VISION Ascendus Diagnostic Ultrasound Scanner [K 110673] and Hitachi Prosound F75 Diagnostic Ultrasound Scanner |K123828|. The subject and predicate systems that incorporate the same fundamental and scientific technologies. Both the subject and predicate device systems have the same intended use/ indications for use.

	Subject	Predicates
Function	Hitachi Aloka
Medical, Ltd.
Arietta 70*/
Arietta S70*/
Arietta V70*	Hi Vision
Ascendus
K110673	Prosound F75
K123828
Color Flow	X	X	X
TDI (Tissue Doppler Imaging)	X	X	X
Trapezoid	X	X	X
Measurement function	X	X	X
Dual Doppler	X	X	X
Marking assist display	X	X	NA
Real-time Doppler Auto Trace	X	X	X
Spatial Compound	X	X	X
FAM (Free Angular M-mode)	X	X	X
HI REZ/ AIP	X	X	X
EyeballEF	X	X	NA
DSD (Dynamic Slow motion Display)	X	NA	X
CHI/ CHE	X	X	X
EFV (Extended Field of View)	X	X	X
Stress Echo	X	X	X
DICOM	X	X	X
DICOM SR	X	X	X
DICOM QR	X	X	X
Real-time Tissue Elastography	X	X	X
RVS (Real-time Virtual Sonography)	X	X	NA
Picture in Picture	X	X	NA
Freehand 3D	X	X	X
Real-time 3D	X	X	X
3D STIC	X	X	X
Automated IMT measurement	X	X	X
Automated NT measurement	X	NA	X
ET (eTracking/ echo Tracking)	X	NA	X
FMD (Flow Mediated Dilatation)	X	NA	X

*The Hitachi Arietta 70 / Arietta S70 / Arietta V70 are cxactly the exception of different color outer shell.

510(K) Premarket Notification - Arietta 70 / Arietta S70 / Arietta V70 Ultrasound Diagnostic System and Probes

2

K134016
Page 3 of 3

21 CFR Part 807.92. Section b

1. Non-clinical Testing
  No new hazards were identified with the subject device and its transducers have been evaluated for acoustic output, biocompaibility, cleaning & disinfection effectiveness, clectromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
1. Clinical testing:
  None required

3. Conclusions:

The Hitachi Aloka Medical, Ltd. AriettaS70/ AriettaV70 Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate device;

1 The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
해 The subject and predicate device(s) have the same gray scale and Doppler capabilities.
피 The subject and predicate device(s) have the same essential technology for imaging. Doppler functions, and sienal processing.
. The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
l The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
. The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
l The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1: all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
. The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning. disinfection, and sterilization in the Ultrasound system and transducer manuals.

END OF SUMMARY

3

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of a stylized caduceus, which is a symbol of medicine and health. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28, 2014 Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical America) % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492-7502

Re: K134016

Trade/Device Name: Arietta70 / AriettaV70 Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 24, 2014 Received: January 29, 2014

Dear Ms. Van Arsdale:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Arietta 70/Arietta V70 Diagnostic Ultrasound Scanner, as described in your premarket notification:

	Transducer Model Number
C251	C41V1	C41V
CC41R	R41R	C42T
L64	S12	VC34
VC41V	C41L47RP	UST-2265-2
UST-5293-5	UST-52126	C41
C42	C35	C22P
C25P	C41RP	C42K
L34	L441	L55
L46K	S31	S31KP
VL54	UST-2266-5	UST-5418

4

Page 2-Ms. Van Arsdale

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance 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 yours.

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

5

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) KI34016

Device Name

Hitachi Arietta70/AriettaS70/AriettaV70 Ultrasound Diagnostic System

Indications for Use (Describe)

The Hitachi Aloka Medical, Ltd. ArietaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiatic, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Dopler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

TTTT FOR FDA USE ONLY .............................................................................................................................................................................. : ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.7)

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 413-6740

6

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of Information unless it displays a currently valid OMB number."

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

Laparoscopic Pedialric

Small Organ (Spec )

Trans-esoph. (non-Card.)

Musculo-skel. (Convent.)

Musculo-skel. (Superlic.)

Trans-esophageal (card )

Nennata) Cephalic

Adult Cephalic

lirans-recial

Trans-vaginal Trans-urchral

Intra-luminal Other (spec.) Cardiac Adult

Cardiac Pediutric

Other (spec.) Peripheral vessel

Other (spec.)

DIAGNOSTICULTRASOUNDINDICATIONSFORUSEFORM

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	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.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro)	P	P	P		P	P	P
	Laparoscopic	P	P	P		P	P	P

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Device Name: Hitachi Arietta 70 / Ariella S70 / Arietta V70

N = new indication. P = previously cleared in K123828 and K130308

· Combination of each operating mode, B, M, PWD, CWD and Color Doppler.

· Committer of techning move by Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Real Time Tissue Elassognphy, Real Time Virtual Sonography

Additional Comments:

Cardiac

Peripheral

Vessel

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 pediatric patients
Subscript "h":	Includes imaging for guidance of trans-rectal biopsy.
	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 I lealth Office of In Viro Diagnostics and Radiological Health 210(k)

Page 2 of 32

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510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

8

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: (.35)

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

Clinical Application		Mode of Operation
General
(Track 1 only)	Specific
(Tracks I & II)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	P	P
	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.)
	Musculo-skel (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication P = previously cleared in KH10673

*Combination of each operating mode, B, M, PWD, and Color Doppler

• Comminded of cach of claim Flow Anglogaphy ), Tissite Duppler Imaging, 3D Imaging, Real Time Virtual Sonography

Additional Comments

theludes imaging for guidance of percutanents bropsy of abdumnal organs and stractures (ancluding anniocentess) Subscript "u"

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

(excluding neurosurgery and laparoscopic procedures).

Subscript "€"* Includes thyroid, parathyroid, breast, scrotum, and penis.

Includes thyroid, parathytoid, breast, scrotum, pens, and imaging for guidance of biopsy, Subscript "d":

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

Includes imaging for guidance of trans-vagmal bropsy Subscript "T"

For pediatric patients Subscript ¨g `:

Includes imaging for guidance of trans-rectal biopsy Subscript "h"

Prescription Use Only (Per 21 CFR 501,109)

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

(Division Sign-Off) Division of Radiological Health Office of In Fitro Diagnostics and Radiological Health う (()(k)______________________________________________________________________________________________________________________________________________________________________

Page 3 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

9

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transduccr: C41V1

Intended use: Diagnostic ultrasound imaging or Nuid Now 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	Abdominal
& Other	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 (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.) Gynecological	P	P	P		P	P	P

N = new indication P = previously cleared in K 1 3030X

· Combination of each operating mode, B. M. PWD, and Color Doppler

• Ampiltude Doppier (Color Flow Angiography). 3D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography

Addinonal Comments

Includes imaging for guidance of perculancous hiopsy of abduminal organs and structures (including amniocentesis). Subscript "อ":

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

(excluding neurosurgery and laparoscopic procedures)

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

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

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

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

Subscript "g": For pediauric patients

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

Prescription Use Only (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BEI.OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Fleath (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(k)

Page 4 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

10

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: C4 I V

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 (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) Gynecological	P	P	P		P	P	P

N = new indication. P = previously cleared in K130308

· Combination of each operating mode, B. M. PWD, and Color Doppler.

** Amplitude Doppler (Color Flow Angiography). 3D Imaging. Real Time Tissue Elastography. Real Time Virtual Sonography

Additional Commons:

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).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":
Includes thyroid, parathyroid, breast, scrowm, penis, and imaging for guidance of biopsy. Subscript *di":
Includes imaging for guidance of trans-rectal biopsy Subscript "c".

Includes maging for guidance of trans-vaginal bropsy Subscript "1"

For nediatric patients Subscript "g".

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

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 Fitro Diagnostics and Radiological Health (OIR)

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

Page 5 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

11

Device Name:	Hitachi Arietta 70 / Arietta S70 / Arietta V70
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	CWI	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	Pc	Pc	Pc		Pc	Pc	Pc
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K110673

· Combination of each operating mode, B. M. PWD, and Color Duppler.

· Ampliade Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Nastography, Real Time Virtual Sonography

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 pediatric patients
Subscript "h":	Includes imaging for guidance of trans-rectal biopsy.
	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 Viro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In I itro Diagnostics and Radiological Health 510(k)________________________________________________________________________________________________________________________________________________________________________

Page 6 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

12

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 R41R Transducer:

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 1 & 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 (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K130308

· Combination of each operating mode, B. M. PWD, and Color Doppler.

· Ampliude Doppler (Color Flow Anglography), 3D Imaging, Real Turne Tissue Elastography

Additional Comments

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

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

(excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c".
Includes thyroid, parathyroid, breast, scrotum, penis, and maging for guidance of biopsy. Subscript "d":
Includes maging for guidance of trans-rectal biopsy Subscript "c"
Subscript "I" Includes imaging for guidance of trans-vaginal hiopsy
Subscript "'g": For pediatric patients
Subscript "h" Includes maging for guidance of trans-rectal bropsy.

Prescription Use Only (Per 21 CFR 801,109)

(PLEASE DO NOT WRITE BEI.OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CI)RH, Office of In I'iro Diagnostics and Radiological Health (OIR)

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

Page 7 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

13

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: C42T

Intended use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks 1 & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)	P	P	P		P	P	P
	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 (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in KI 10673

Combination of each operating mode, B. M. PWD, and Colur Doppler
Amplitude Dopper (Color Flow Angiography), 3D Inaging, Real Time Tissue Filastography, Real Time Virtual Sonveraphy

Additional Comments:

Subscript "a": Includes imaging for guidance of perculunenas bionsy 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, scrorum, 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 "c":

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

For pediatric patients Subscript "g":

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

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 Firm Diagnostics and Radiological Health (OIR)

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

Page 8 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

14

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: 1.64

Intended use: Diagnostic ultrasound imaging or Nuid Now 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. (Supertic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in KI30308

· Combination of each operating mode, B. M. PWD, and Color Doppler.

· Amplitude Doppler (Color Flow Angiography). Real Time Tissue Elastography

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, scrown, and penns Subscript "c"

Includes thyroid, parathyroid, breast, servitum, penis, and maging for guidance of bropsy Suhscript "d"

Includes imaging for guidance of trans-rectal biopsy Subscript "c"

Includes imaging for guidance of trans-vagunal bropsy Subscript "f"

For pediatric patients Subscript "g"

Includes imaging for guidance of trans-rectal bropsy. Subscript "h":

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 Viro Diagnostics and Radiological Health (OIR)

(Division Sign-Ofl) Division of Radiological Health Office of In Firo Diagnostics and Radiological Health 510(k)

Page 9 of 32

510[K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

15

Device Name: Hilachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: SI2

Intended use: Diagnostic ultrasound imaging or thuid thow 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	Abdominal	P	P	P	P	P	P	P
& Other	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. (Supertic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card )
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P
Vessel	Other (spec.)

N = new indication. P = previously cleared in K110673

· Combination of each operating mode, B. M. PWD, CWD and Color Doppler.

• Ampliude Doppler (Color Flow Angiography). Tissue Donnier Imaging, 3D Imaging, AD Imaging, Real Time Tissue Elastography

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

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

For pediatric patients Subscript "g":

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

Prescription Use Only (Per 2) CFR 801.109)

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

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

Page 10 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

16

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: VC34

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

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.)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.) Gynecological	P	P	P

N = new indication. P = previously cleared in KI 110673

Combination of each operating mode. B. M. PWD, and Color Doppler.

· Amplitude Doppler (Color Flow Angiography). Tissue Doppler Imaging, 3D Imaging

Additional Comments:

Includes imaging for guidance of perculaneous hiopsy of abdominal organs and structures (including amniocentusis) Subscript "a":

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

(excluding neurosurgery and laparoscopic procedures).

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

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

Includes imaging for guidance of trans-rectal hiopsy Subscript "c":

Subscript "1": Includes imaging for guidance of trans-vaginal hiopsy.

For pediatric patients Subscript "g"-

Includes imaging for guidance of trans-rectal biopsy. Subscript "h".

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-Ofl) Division of Radiological Health Office of In I'm Diagnostics and Radiological Health 510(k)

Page 11 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

17

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: VC4IV

Intended use: Diagnostic ultrasound imaging or Nuid How 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
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) Gynecological	P	P	P		P	P	P

N = new indication. P = previously cleared in K123828

*Combination of each operating mode, B. M. PWD. and Color Doppler. · * Amplitude Doppler (Color Flow Angiography), 41) Imaging

Additional C `omment

Subscript "a"								Includes muging for guidance of perculanents bropsy of abdominal organs and structures (including ammocentents).
---------------	--	--	--	--	--	--	--	------------------------------------------------------------------------------------------------------------------	--	--	--	--	--	--	--	--

Includes maging of organs and structures exposed during surgery Subscript "b"

(excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyrnid, breast, scrotum, and penis Subscript "c"
Includes thyrold, parathyrond, breast, scrowin, penis, and imaging for guidance of biopsy. Subscript "d"

Subscript "c". Includes imaging for guidance of trans-rectal hiopsy

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

Subscript "g": For pediatric patients

Includes imaging for guidance of trans-rectal biopsy. Subscript "'h":

Prescription Use Only (Per 21 CFR 801.109)

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(k)

Page 12 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

18

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: C4 !L4 7RP

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

Clinical Application		Mode of Operation
General
(Track 1 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	Ph	Ph	Ph		Ph	Ph	Ph
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in KI 10673

Combination of each operating mode. B. M. PWD. and Color Doppler.

· Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography

Additional Comments;

Includes imaging for guidance of perculaneous 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).

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

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

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

Includes imaging for guidance of trans-vaginal bropsy Subscript "I"

For pediatric patients Subscript "g"

Includes maging for guidance of trans-rectal bropsy. Subscript "h"

Prescription Cise 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 Titro Diagnostics and Radiological Health (OIR)

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

Page 13 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

19

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: 05.1.-3565-2 Intended use: Diagnostic ultrasound imaging or thuid flow analysis of the human body as follows:

Mode of Operation Clinical Application () M PWD ("WD Color Combined® Other ** General Specific (Tracks 1 & III) Doppler (Spec.) (Spec.) (Track I only) Ophthalmic Ophthalmic Fetal Fetal Imaging Abdominal & Other Intra-operative (Spec.) Intra-operative (Neuro.) l aparoscopic Pedigiric 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 (spec.) P Cardiac Adult Cardiac Pediatric Cardiac Trans-esophageal (card ) Other (spec.) Peripheral vessel Peripheral Vessel Other (spec.)

N = new indication P = previously cleared in K123828

· Combination of each operating mode, B. M. PWD, CWD and Color Doppler

Committed: Doptior (Color Play, C + + D Dand Contr Priped
** Amplatude Dopter (Color Flow Anglogaphy). Tissue Dupply 1 Imaging. 41) Imaging. Real Time Tissue Elustography

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 "c":	Includes imaging for guidance of trans-rectal biopsy
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For pediatric patients
Subscript "h":	Includes imaging for guidance of trans-rectal biopsy.
	Prescription Use Only (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQUITIER PAGE IF MEEDED)

Concurrence of CDRH. Office of In Titro Diagnostics and Radiological Health (OR)

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

Page 14 of 32

510{K} Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

20

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: US1.-5293-5 Intended use: Diagnostic ultrasound imaging or thuid tlow analysis of the human body as follows:

Mode of Operation Clinical Application Specific 13 M ו"WD (WD Color Combined Other * * General 1)oppler (Track I only) (Tracks I & III) (Spec.) (Spec ) Ophthalmic Ophthulmic Feal Fetal Imaging Abdominal & Other Intra-operative (Spec.) Intra-operative (Neuro ) I .aparoscopic Pedialtri Small Organ (Spec.) Neonatal Cephalic Adult Cephalic Trans-reclai Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) p P p p P Cardiac Adult p P Cardiac Pediatric Cardiac P ూ P レ p P P Trans-esophageal (card.) Other (spec. ) Peripheral Peripheral vessel Other (spec.) Vessel

N = new indication, P = previously cleared in K123828

*Combination of each operating mode, B. M. PWD. CWD and Color Doppler.

· Amplitude Doppler (Color Flow Angiography). 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)
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 "I":	Includes imaging for guidance of trans-vaginal biopsy
Subscript "g":	For pediatric patients
Subscript "h":	Includes imaging for guidance of trans-rectal biopsy

Prescription Use Only (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHIER PAGE IF NEFDEID) 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

રાભા)

Page 15 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

21

Device Name: Hitachi Ariella 70 / Arietta S70 / Arietta V70 Transducer: UST-52126

Intended use: Diagnostic ultrasound imaging or iluid 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 (spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric
	Trans-esophageal (card.)	P	P	P	P	P	P	P
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in KI23828

· Combination of cach operating mode, B. M. PWD, CWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography). Tissue Doppler Imaging

Additional Comments

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

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

(excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c"
Includes thyroid, parathyroid, breast, scrotum, penis, and maging for guidance of biopsy Subscript "d":
Includes imaging for guidance of trans-rectal hiopsy Subscript "c":
Includes imaging for guidance of truns-vaginal biopsy. Subscript "L":
For pediatric patients Subscript "g":
Subscript "h": Includes imaging for guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

Page 16 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

22

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 17 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

23

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 l'ransducer: ('42

Intended use: Diagnostic utrasound imaging or thuid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only )	Specific
(Tracks I & III)	B	M	MVD	CWD	Color
Doppler	Combined®
(Spec )	Other **
(Spec)
( )phthalmic	Ophilialmic
	Felal
Fetal Imaging	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
& Other	Intra-operative (Spec.)	Pb	Pb	PP		Ph	Ph	Po
	Intra-operative (Neuro.)
	Laparoscopic
	Pedialric	P	P	p		p	p	P
	Small Organ (Spec )	Pd	જ્વ	Pd		ba	Pd	ba
	Neonatal Cephalic	P	P	ு		p	p	P
	Adult Cephalic
	Trans-recol
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card )
	Musculo-skel. (Convent.)
	Musculo-skel. (Supertic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pedialric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (spec.)

N = new indication. P = previously cleared in KI 30308

· Combination of each operating mode. B. M. I'WD and Color Doppler

Commandin of cach openang mose D. W. I W I W I and Collection of the Time Virus! Songraphy

Additional Comments

Includes maging for guidance of perculancous bionsy of abdominal organs and structures ( including ammocentesis). Subscript "a" Includes imaging of organs and structures exposed during surgery Subscript "b" (excluding neurosurgery and laparoscopic procedures) Includes thyroid, parathyroid, breast, scrowm, 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": Includes imaging for guidance of trans-vaginal biopsy. Subscript *f":

Subscript "g": For pediatric patients

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

Prescription Use Only (Per 21 CFR 801.109)

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

(Division Sign-Off) . Division of Radiological Health Office of In I'itro Diagnostics and Radiological Health 510(k)

Page 18 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

24

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: ૮૩૬

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

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.)	Pc	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 (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication. P = previously cleared in K110673

· Combination of each operating mode, B. M. PWD, CWD and Color Doppler

Continution of cath operating move, 2, w. I WD, CV D and Golder 170pppe, AD Imaging, Real Time Tissue Elastography

Additional Comments:

Subscript "a":	Includes imaging for guidance of perculancous 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 theroid, parathyroid, breast, scrotum, penis, and maging for guidance of bropsy.
Subscript "c"	Includes imaging for guidance of trans-rectal bionsy
Subscript "I"	Includes imaging for guidance of trans-vagmal bropss
Subscript "g"	lior pediatric patients
Subscript "Th"	Includes imaging for guidance of trans-rectal bropsy.
	.

Prescription Use Only (Per 21 CFR 801.109)

(PL)EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFDED) Concurrence of CDRIT. Office of In Titro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of in Vitro Diagnostics and Radiological Health 510(k)_

Page 19 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

25

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: (:221)

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWID	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 (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication. P = previously cleared in KII0673

Combination of each operating mode, B. M. PWD, and Color Doppler.

· * Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Virtual Sonography

Additional Comments:

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

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

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathyroid, breast, scrolum, and penis. Subscript "c"

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

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

Includes imaging for guidance of trans-vaginal hiopsy. Subscript "I":

For podiatric patients Subscript "g":

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

Prescription Use Only (Per 2) CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDE!)) Concurrence of CDRM. Office of In Titro Diagnostics and Radiological Mealth (OIR)

(Division Sign-Ofl) Division of Radiological Health Office of In Fitro Diagnostics and Radiological Health 510(k)

Page 20 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

26

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: C25P

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

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 (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. I? = previously cleared in K110673

· Combination of each operating mode, B. M. PWD, CWI) and Color Doppler.

· Amplitude Doppler (Color Flow Angiography), JD Imaging, Real Time Virtual Sonography

Additional Comments:

Includes imaging for guidance of perculanenus hiopsy of abdominal organs and structures (including amniocentesis) Subscript "a":

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, scrown, penis, and imaging for guidance of biopsy. Subscript "d":

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

Subscript "1". Includes imaging for guidance of trans-vaginal biopsy

Subscript "g": For pediatric patients

Includes imaging for guidance of trans-rectal biopsy Subscript "h"

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 Nealth (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Fitro Diagnostics and Radiological Health 210(k)_

Page 21 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

27

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: C41RP Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

1 Clinical Application Mode of Operation

| General
(Track I only) | Specific
(Tracks 1 & III) | B | M | PWD 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 (spec.) | | Cardiac Adult | Cardiac | Cardiac Pediatric | | Trans-esophageal (card.) | | Other (spec.) | Peripheral | Peripheral vessel | Vessel | Other (spec.) | CWD | Color
---------------|----|----|-----|-----|------------------|----------------------|--------------------|
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| Pe | Pe | Pe | | Pe | Pe | Pe |
| Pf | Pf | Pf | | Pf | Pf | Pf |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |

N = new indication. P = previously cleared in K123828

· Combination of each operating mode, B, M, PWD. CWD and Color Doppler.

· Ampination Doppler (Color Flow Angiography). Tissue Doppler Imaging, 31) Imaging, Reel Time Tissue Hastography

Additional Comments

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

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

(excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scronum, and penis Subscript "t":
Includes thyrold, parathyroid, breast, scritum, penis, and imaging for guidance of biopsy Subscript "d"
Includes imaging for guidance of trans-rectal hiopsy Subscript "c"
Includes imaging for guidance of trans-vaginal bropsy. Subscript "I":

Subscript "g": For pediatric patients

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

Prescription Use Only (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHIER 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)

Page 22 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

28

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 I ransducer: ('42K

Intended use: Diagnostic ultrasound imaging or thiid How 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.)	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 (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication. P = previously cleared in K130308

*Combination of each operating mode, B. M. PWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography)

Additional Comments

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

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

(excluding neurosurgery and laparoscopic procedures).

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

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

Includes unaging for guidance of trans-recual hiopsy Subscript "e":

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

For pediatric patients Subscript "g":

Includes imaging for guidance of trans-rectal hiopsy. Subscript "h"

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 Tiealin (OIR)

(Division Sign-Off) Division of Radiological Health Office of In I itro Diagnostics and Radiological I Icalth 510(k)________________________________________________________________________________________________________________________________________________________________________

Page 23 of 32

510(K) Premarket Notification ~ Arietta 70 Ultrasound Diagnostic System and Probes

29

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 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	Pd
	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 (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P
Vessel	Other (spec.)

N = new indication. P = previously cleared in K130308

*Combination of cach operating mode, B, M, PWD, CWD and Color Doppler.

** Amplitude Doppler (Color Flow Anging Real Time Tissue Elastography, Real Time Virtual Sonography

Additional Comments:

Includes imaging for guidance of perculances buyes) of abdominal organs and structures (metwaing amonocentesis) Subscript "a":

Includes imaging of organs and structures exposed during surgery Subscript "h"

(excluding neurosurgery and laparoscopic procedures)

Includes thyroid, parathyroid, breast, scrolum, and penis Subscript "c"

Includes thyroid, parathyroid, breast, scrown, penis, and maging for guidance of biopsy. Subscript "d"

Subscript "c" Includes maging for guidance of trans-rectal biopsy

Includes imaging for guidance of trans-vaginal biopsy Subscript "T`.

Subscript "g": For pediatric patients

Includes imaging for guidance of trans-recult biopsy. Subscript "h":

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 Fifro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(K)

Page 24 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

30

Device Name: Ilitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: L44 ! Diagnostic ultrasound imaging or tluid flow analysis of the human body as follows: Intended use:

Clinical Annlication Mode of Oneration

Clinical Application		Mode of Operation
General
(Track 1 only)	Specific
(Tracks I & III)	B	M	PWI	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.)	Pd	Pd	Pd	Pd	Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	Pd	Pd	Pd	Pd	Pd	Pd	Pd
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	Pd	Pd	Pd	Pd	Pd	Pd	Pd
	Other (spec.)

N = new indication, P = previously cleared in K123828

· Combination of each operating mode. B. M. PWD. CWD and Color Doppler

Combination of cach of en 1 m 2 , C W 2 and Color Dopper
Ampiliude Dopper (Color Flow Anging, 3D Imaging, 3D Imuging, 3D Imuging, Real Time Tissue Elastography,

Additional Comments

Includes imaging for guidunce of perculanevus biopsy of abdominal orguns and structures (including amniocenters). Subscript "a":

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 maging for guidance of biopsy Subscript "di":

Includes imaging for guidance of trans-rectal hiopsy Subscript "c".

Includes imaging for guidance of trans-vagmal bronsy Subscript "f":

For pediatric patients Subscript "g"

Includes maging for guidance of trans-rectal hiopsy. Subscript "h"

Prescription Use Only (Per 21 CFR 801, 109)

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

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

Page 25 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

31

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: 1.55

Intended use: Diagnostic ultrasound imaging or thid 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 (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K130308

· Combination of each operating mode, 13, M. PWI), CWI), and Color Doppler.

Amplitude Doppler (Color Flow Angiography),31) Imaging. Real Time Tissue Hastography. Real Time Virtual Sonography,

Additional Comments

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

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

(excluding neurosurgery and laparoscopic procedures).

includes theroid, parathyroid, breast, scrotum, and penis. Subscript "c"

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

Includes imaging for guidance of trans-rectal biopsy Subscript "c"

Includes imaging for guidance of trans-vaginal biopsy Subscript "I`

Subscript "g": For pediatric patients

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

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 Mealth (OR)

(Division Sign-Off) Division of Radiological Health Office of In Fitro Diagnostics and Radiological Health 510(k)________________________________________________________________________________________________________________________________________________________________________

Page 26 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

32

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: L46K

Intended use: Diagnostic ultrasound imaging or Huid How analysis of the human body as lollows:

| | 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 | Pb | Pb | Pb | | Pb | Pb | Pb | |
| | 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 (spec.) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | . | | | | | | | | |

N = new indication. P = previously cleared in K123828

· Combination of each operating mode, B. M. PWD. CWD and Color Doppler

· Ampluade Doppler (Color Flow Anglography), 31) Imaging, Real Time Virtual Sonography

Additional Comments:

Includes imaging for guidance of perculancous hiopsy of abdoninal organs and structures (including amniocentess) Subscript "a"

Includes imaging of organs and structures exposed during surgers Subscript "b"

(excluding neurosurgery and laparoscopic procedures).

Includes thyroid, parathytoid, 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 hiopsy Subscript "te"

Includes imaging for guidance of trans-voginal hiopsy. Subscript "Г"

Subscript "g": For pediatric patients

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

Prescription Lise Only (Per 21 CFR 801.109)

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

(Division Sign-Oli) Division of Radiological Health Office of In Fitro Diagnostics and Radiological Health 510(k)_

Page 27 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

33

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: 231

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks 1 & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	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 (spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K130308

· Combination of each operating mode, B. M. PWD, CWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography). Tissue Doppler Imaging

Additional Comments

Includes imaging for guidance of perculaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a": Subscript "h" Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures) Includes thyroid, parathyroid, breast, scrotum, and pens Subscript "c" Includes thymid, parathyroid, breast, scronum, penis, and imaging for guidance of biopsy Subscript "d" Includes imaging for guidance of trans-recial bropsy Subscript ''c Subscript "T Includes maging for guidance of trans-vaginal biopsy Subscript "g": For pediatric patients

Includes imaging for guidance of trans-rectal bropsy. Subscript "h":

Prescription Use Only (Per 21 CFR 801, 109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ()N ANOTHER PAGE IF NEEDED) . Concurrence of CDRT, Office of In Titro Diagnostics and Radiological Ticalth (OIR)

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

Page 28 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

34

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: 231KP

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

| 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.) | Pb | Pb | Pb | Pb | Pb | Pb | Pb |
| | 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 (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication, P = previously cleared in K123828 *Combination of each operating mode. B. M. PWD. CWD and Color Doppler

Combination on each operating mode, B, M, PW, S

Amplitude Doppler (Color Flow Angiography)

- Amplitude Doppler (Color Flow Angiography)

Additional Comments:

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

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

(excluding neurosurgery and laparoscopic procedures).

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

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

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

Includes imaging for guidance of trans-vaginal biopsy. Subscript "1":

Subscript "g": For pediatric patients

Includes imaging for guidance of trans-rectal biopsy Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFDED) Concurrence of CDRH. Office of In Titro Diagnostics and Radiological Ticality (OIR)

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

Page 24 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

35

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: VL54

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

Clinical Application Mode of Operation Other ** B M PW13 CWD General Specific Color Comhined (Tracks | & III) (Track I only) Doppler (Spec.) ו Spec ו Ophthalmic Ophthalmış Fetal Fetal Imaging 12 P p P Abdominal P P & ()ther Intra-operative (Spec.) Intra-operative (Neuro.) l aparoscopic Pediatric r P P P P P Small Organ (Spec.) Pc Pc Pc Pc Pc Pc Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urcthral Trans-esoph (non-Card.) Musculo-skel (Convent) P P P P P P Musculo-skel. (Superfic.) P p l' P P P Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophagent (card.) Other (spec.) p e p p D P Peripheral vessel Perinheral Vessel Other (spec.)

N = new indication. P = previously cleared in KI10673

· Combinution of each operating mode. B. M. PWI), and Color Doppler.

· Amplitude Doppler (Color Flow Anglography), 3D Imaging, Real Time Tissue Flastography

Additional Comments:

Includes maging for guidance of perculanced biopsy of abduminal organs and structures (including amniocentesis) Subscript "a".

Includes imaging of organs and structures exposed during surgery Subscript "h"

(excluding neurosurgery and laparoscopic procedures)

Subscript "c" Includes theroid, parathyroid, breast, scrolum, and penis

Includes thyroid, parathyroid, breast, serotum, penis, and imaging for guidance of bropsy Subscript "d"

Includes imaging for guidance of 11:10s-rectal biopsy Subscript "c"

Includes imaging for guidance of trans-vaginal biopsy. Subscript *17:

Subscript "g": For pediatric patients

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

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 Virro Diagnostics and Radiological Health (OIR)

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

Page 30 of 32

510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

36

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: US.1.-5266-2

Intended use: Diagnostic ultrasound imaging or thiid thow 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-csoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel				P
Vessel	Other (spec.)

N = new indication. P = previously cleared in K123828

· Combination of cach operating mode. B. M. PWD. CWD and Color Doppler.

Ampirude Dopper (Color Flow Angiography). Tissue Doppics Imaging, AD Imaging, Real Time Tissue Elastography

Additional Comments:

Includes imaging for guidance of percutancous hiopsy of abdominal organs and structures (including aminocentesis). Subscrip1 "a":

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

(excluding neurosurgery and laparoscopic procedures).

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

Subscript "ປັ": Includes theroid, paratheroid, breast, scrolum, penis, and imaging for guidance of bropsy.

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

Includes imaging for guidance of trans-vaginal hiopsy Subscript "I":

Subscript "g": For nediatric patients

Includes imaging for guidance of trans-rectal hiopsy Subscript "h"

Prescription Use Only (Per 21 CFR 801 .109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFDED) Concurrence of CDRM. Office of In Fitro Diagnostics and Radiological Health (OIR)

(Division Sign-Oth) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(k)

Page 31 of 32

510[K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes

37

Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: UST-5418 Intended use: Diagnostic ultrasound imaging or Theid Now analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(Track 1 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.)	N	N	N		N	N	N
	Intru-operative (Neuro.)
	Laparoscopic	P	P	P		P	P	P
	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 (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication. P = previously cleared in K ( 30308

· Combination of each operating mode, B. M. PWID, and Color Doppler.

· Amplitude Doppler (Color Flow Angiography), 3D Imaging. Real Time Tissue Elastography

Additional Comments:

Includes imaging for guidonce of perculancous hiopsy of abdominal organs and structures (including ammocentesis). 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 pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |

Prescription Use Only (Pe

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

(Division Sign-Oft) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(k)_

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510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes