The HI VISION Avius is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

Device Description

An ultrasound system consists of the following:

Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
A computer system to control the transducer and analyze the signals resulting from the reflected echoes
A video monitor with optional image recorder to display the computed image or derived Doppler data

AI/ML Overview

The Hitachi HI VISION Avius Diagnostic Ultrasound Scanner (K102901) is intended for diagnostic ultrasound evaluation across various clinical applications. The submission primarily relies on substantial equivalence to a predicate device (HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner K093466) rather than presenting new clinical study data with specific acceptance criteria and performance metrics for the Avidus. Therefore, the information typically found in acceptance criteria tables and detailed study reports for efficacy and performance (e.g., sensitivity, specificity, reader performance) is not available here.

However, the document does list the intended uses for each transducer with the modes of operation as a form of "acceptance criteria" through successful comparison to the predicate device. The "study" proving the device meets these criteria is the submission for substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device, K093466, for each clinical application and mode of operation listed. The "reported device performance" is the assertion that the new device (HI VISION Avius) performs equivalently to the predicate for these applications.

The tables for each transducer (e.g., EUP-B512, EUP-B514, EUP-C511, etc.) indicate the approved clinical applications and the modes of operation. A "P" signifies that the clinical application and mode were previously cleared in the predicate device (K093466), implying the new device meets the same performance standards.

Clinical Application (Example: Fetal)	Mode of Operation (B, M, PWD, CWD, Color Doppler, Combined, Other*)	Reported Device Performance (Implicitly: Substantial Equivalence to K093466)
Fetal	P (B, M, PWD, CWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Fetal imaging.
Abdominal	Pa (B, M, PWD, CWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Abdominal imaging.
Intra-operative (Spec.)	Pb (B, M, PWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Intra-operative imaging.
Pediatric	P (B, M, PWD, CWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Pediatric imaging.
Small Organ (Spec.)	Pc/Pd (B, M, PWD, CWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Small Organ imaging.
Neonatal Cephalic	P (B, M, PWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Neonatal Cephalic imaging.
Adult Cephalic	P (B, M, PWD, CWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Adult Cephalic imaging.
Trans-rectal	Pe/Ph (B, M, PWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Trans-rectal imaging.
Trans-vaginal	Pf (B, M, PWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Trans-vaginal imaging.
Musculo-skeletal (Convent.)	P (B, M, PWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Musculoskeletal imaging.
Musculo-skeletal (Superfic.)	P (B, M, PWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Musculoskeletal imaging.
Cardiac Adult	P (B, M, PWD, CWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Cardiac Adult imaging.
Cardiac Pediatric	P/Pg (B, M, PWD, CWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Cardiac Pediatric imaging.
Trans-esophageal (card.)	P (B, M, PWD, CWD, Color Doppler, Combined, Other) (for EUP-ES52E, EUP-ES52M)	Functions equivalently to the predicate device for Trans-esophageal Cardiac imaging.
Peripheral vessel	P (B, M, PWD, CWD, Color Doppler, Combined, Other)	Functions equivalently to the predicate device for Peripheral vessel imaging.

Combined: Combination of each operating mode (B, M, PWD, CWD, Color Doppler).
Other: Amplitude Doppler, Harmonic Imaging, 3D Imaging, 4D Imaging (for Preirus, Avidus lists up to 3D), Real Time Tissue Elastography, Trapezoid, Contrast, Oblique, High Compound Imaging, Omni Directional M-mode, Wide View, Tissue Doppler Imaging. Specific "Other" modes vary slightly by transducer.
Subscripts (a, b, c, d, e, f, g, h) denote specific types of imaging within broader categories (e.g., biopsy guidance).

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

The document primarily relies on engineering and design comparison to establish substantial equivalence, stating that "The technological characteristics of this device are identical to the primary predicate device. The control and image processing hardware and the base elements of the system software are identical to the predicate device."

For the new transmitter, mentioned as an exception, the validation is included in "Section 6 - Clinical Safety & Effectiveness." However, this summary document does not provide details about the sample size, data provenance, or whether this validation involved a clinical test set. Given the date of the submission (2010), extensive clinical trial data with specific sample sizes for each clinical application would typically not be required for a substantial equivalence claim for an ultrasound device unless new fundamental technology or clinical indications were introduced.

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

This information is not provided in the supplied document. Such details are usually part of a specific clinical study report, which is not present here. The submission focuses on technical equivalence to an already cleared device.

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

This information is not provided in the supplied document.

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

No MRMC comparative effectiveness study is mentioned, nor is there any mention of AI assistance in this submission. The device is a diagnostic ultrasound scanner, and at the time of this filing (2010), AI in medical imaging was not as prevalent as it is today.

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

This is not applicable to a diagnostic ultrasound scanner that is operated by trained personnel (doctor, sonographer).

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

This information is not provided for this specific submission, as it relies on substantial equivalence. For the predicate device, K093466, it would have been established through methods appropriate for diagnostic ultrasound, likely involving expert interpretation, correlation with other imaging modalities, or, where applicable, pathology or clinical outcomes.

8. The sample size for the training set

This is not applicable as the submission describes a hardware and software system for an ultrasound scanner and not a new algorithm or AI application. The "training" for such a device would refer to the engineering and development process, rather than an algorithmic training set derived from patient data.

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

Not applicable for the reasons stated above.

Summary

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K/02901

OCT 2 7 2010

. . .

.....

Section 1

、

・・

510(k) Summary

、

(

: 上一篇:

・・・

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・・

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OCT 2 7 2010

Submitter:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371ph: (330) 425-1313fax: (330) 963-0749
Contact:	Douglas J. Thistlethwaite
Date:	September 27, 2010

Device Name

Submitter Information

Classification Name:	System, Imaging, Pulsed Doppler, Ultrasonic
Classification Number:	90-IYN
Trade/Proprietary Name:	HITACHI HI VISION Avius Diagnostic Ultrasound Scanner
Predicate Device(s):	HITACHI HI VISION Preirus Diagnostic Ultrasound ScannerK093466

Device Intended Use

The Modes of Operation of the HI VISION Preirus are B mode, M 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, and Real Time Tissue Elastography.

Device Description

Function

An ultrasound system consists of the following:

Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the ● reflected echoes
� A computer system to control the transducer and analyze the signals resulting from the reflected echoes
A video monitor with optional image recorder to display the computed image or derived . Doppler data

Scientific Concepts

An acoustic wave is a mechanical perturbation of a medium which passes through a given medium at a fixed velocity. The rate at which the particles in the medium vibrate in the disturbance is the frequency of the wave, and is measure as cycles/second, or hertz (Hz). Frequencies above 20 kHz are not audible, and above this frequency, the acoustic energy is known as ultrasound. For the purposes of medical ultrasound imaging, frequencies in the range of 1-20 MHz are utilized.

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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 echo.

The ultrasound transducer, when operating in pulsed mode, periodically emits an ultrasound burst at a predetermined rate described as the pulse repetition frequency (PRF). During the time duration that the transducer is not transmitting ultrasound energy, it may act as a received for the reflected ultrasound energy. Since the speed of propagation of ultrasound in tissues is estimated as 1540m/sec, the time elapsed between transmission of a pulse and receipt of an echo may be used to estimate the distance from the transducer to the tissue structure giving rise to the reflected echo. The relative strength of the reflected echo can be used to determine the brightness of display of the reflected echo or strength of derived Doppler signal.

Physical and Performance Characteristics

The principle of operation of ultrasound imaging involves generation of an ultrasound wave 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.

Device Technological Characteristics

The technological characteristics of this device are identical to the primary predicate device. The control and image processing hardware and the base elements of the system software are identical to the predicate device. See Section 4 - Predicate Device Comparison.

Conclusions

It is the opinion of Hitachi Medical Systems America. Inc. that HITACHI HI VISION Avius Diagnostic Ultrasound Scanner is substantially equivalent to the predicate devices. In addition, we have concluded that the subject system is substantially equivalent with respect to safety, effectiveness, and functionality to the HI VISION Preirus Diagnostic Ultrasound Scanner K093466 with the exception of the new transmitter. The Product Specification for new transmitter is included in Section 3 - General Device Description and the validation is included in Section 6 - Clinical Safety & Effectiveness.

Attachment

Pressure of the contract of the comments of the comments of the comments of the first of the first of the first of the first of the first of the first and the first and the fATTACHMENT	POSITION
Declaration of Conformity with Design ControlsChildren and Children and Children and Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three overlapping strokes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371

OCT 2 7 2010

Re: K102901

Trade/Device Name: HI VISION Avius Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 27, 2010 Received: September 30, 2010

Dear Mr. Thistlewaite:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the HI VISION Avius Diagnostic Ultrasound Scanner, as described in your premarket notification:

Transducer Model Number

EUP-B512	EUP-CV524	EUP-L54MA
EUP-B514	EUP-CV714	EUP-L65
EUP-C511	EUP-ES52E	EUP-L73S
EUP-C514	EUP-ES52M	EUP-L74M
EUP-C516	EUP-F334	EUP-LV74
EUP-C524	EUP-F531	EUP-053T
EUP-C532	EUP-L52	EUP-054J
EUP-C715	EUP-L53	EUP-OL334
EUP-CC531	EUP-L53L	EUP-R54AW-19, -3

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EUP-VV731

EUP-S50A EUP-S52 EUP-S70

EUP-U533 EUP-V53W EUP-VV53 !

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours,

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

103901

OCT 2 7 2010

510(k) Number (if known):

Device Name: HI VISION Avius Diagnostic Ultrasound Scanner

Indications For Use:

The HI VISION Avius is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculosketal, Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The Modes of Operation of the HI VISION Avius are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, and Real Time Tissue Elastography.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-1

Page 1 of

Division of Radiolo

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System:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM HI VISION Avius

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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.)
	Laparoscopic	P	P	P		P	P	P
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic	P	P	P		P	P	P
Fetal Imaging& Other	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal	Ph	Ph	Ph		Ph	Ph	Ph
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	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 (spec.)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)	Pg	Pg	Pg	P	Pg	Pg	Pg
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P
Vessel	Other (spec.)
	N = new indication. P = previously cleared in K093466
	*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
	**Amplitude Doppler, Harmonic Imaging, 3D Imaging, Real Time Tissue Elastography, Torapezoid,
	Contrast, Oblique, High Compound imaging, Omni Directional M-mode,
	Wide View, 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).

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

Subscript	Description
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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

Radiological Devices
510(k) Number: K102901

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System: Transducer

TALL PRO

STATE THE THE PERSONAL PARTY

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler, Harmonic Imaging, Contrast, High Compound imaging, Wide View

Additional Comments

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

ﻟﻠ 10240 510(k) Number:

{8}------------------------------------------------

System: Transducer:

HI VISION Avius EUP-B514

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
Fetal Imaging& Other	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.)

PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Contrast, High Compound imaging, Wide View

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, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IE NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
• Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

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

System: Transducer:

EUP-C511

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

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Contrast, High Compound imaging,

Omni Directional M-mode, Wide View

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOT Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

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

System: Transducer:

EÜP-C514

Clinical Application						Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Contrast, High Compound imaging,

Omni Directional Momode, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

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

System: HI VISION Avius

Transducer: EUP-C516

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application	Mode of Operation

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Contrast, High Compound imaging,

Omni Directional M-mode, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

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

System: HI VISION Avius Transducer: EUP-C524

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, High Compound imaging, Omni Directional Mrmode, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED! WKITE RETOW gli DU INC Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off) 2 Division of Reproductive, Abdominal, ENT, and Radiological Devices

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

System: HI VISION Avius EUP-C532

Transducer:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic	P	P	P		P	P	P
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human oody as follows

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, High Compound imaging, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDBH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K102901

Prescription Use (Per 21 CFR 801.109)

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

System: HI VISION Avius Transducer: EUP-C715

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Contrast, High Compound imaging,

Omni Directional M-mode, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

Prescription Use (Per 21 CFR 801.109)

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

System: Transducer:

EUP-CC531

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, 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).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

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

System:

EUP-CV524 Transducer:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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.)	P	P	P		P	P	P
	Neonatal Cephalic
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, 3D Imaging, High Compound imaging, Omni Directional Mrmode

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

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

System: Transducer:

EUP-CV714

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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.)	P	P	P		P	P	P
	Neonatal Cephalic
Fetal Imaging& Other	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, 3D Imaging, High Compound imaging, Omni Directional Mrmode

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE) -

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

1029 01 510(k) Number:

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

System: HI VISION Avius

Transducer: EUP-ES52E

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	FetalAbdominalIntra-operative (Spec.)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (Spec.)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)
	Intra-luminalOther (spec.)
Cardiac	Cardiac AdultCardiac Pediatric
	Trans-esophageal (card.)Other (spec.)	P	P	P	P	P	P	P
PeripheralVessel	Peripheral vesselOther (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Omni Directional Mimode, 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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDBH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

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

System: Transducer:

EUP-ES52M

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	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.)	P	P	P	P	P	P	P
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Omni Directional M mode, Tissue Doppler imaging

Additional Comments:

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

Subscript "b":	Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

TTE RELOV DU NO ﺗﺎ ON AND TTTC Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number:

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

14102901

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

System: Transducer

EUP-F334

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc		Pc	Pc	Pc
	Neonatal Cephalic	P	P	P		P	P	P
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal	P	P	P		P	P	P
	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	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

WRITE BELOW THIS LINE-CONTINUE ON ANOTHER WRITE BELOW

✓ (Division Sign-Off)
vision of Reproductive, Abdominal, ENT,

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: _

1410200

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

System: HI VISION Avius EUP-F231

Transducer:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc		Pc	Pc	Pc
	Neonatal Cephalic	P	P	P		P	P	P
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal	P	P	P		P	P	P
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler, Harmonic Imaging, Wide View

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

For pediatric patients. Subscript "g": Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K102961

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

System: Transducer:

EUP-L52

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	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-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Intra-luminalOther (spec.)	P	P	P		P	P	P
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid,

Oblique, High Compound imaging, Omni Directional M-mode, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

TTE REDO PLEASE DU NOT Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

ાળુવાડ 510(k) Number:

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

System Transducer:

EUP-L53

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

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid, Oblique, High Compound imaging, Wide View

Additional Comments:

Subscript "b":	Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Deyice Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

Prescription Use (Per 21 CFR 801, 109)

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

HI VISION Avius EUP-L53L

System: Transducer:

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

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid, Oblique, High Compound imaging, Wide View

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, penis.
	Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
	Subscript "e": Includes imaging for guidance of transrectal biopsy.
	Subscript "f": Includes imaging for guidance of transvaginal biopsy.
	Subscript "g": For pediatric patients.
	Subscript "h": Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

ા 510(k) Number:

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

System: Transducer:

EUP-L54MA

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

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid, Oblique, High Compound imaging, Wide View, Omni Directional M-mode

Additional Comments:

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

Subscript "b":	Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

OTTO DELV Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

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

System : HI VISION Avius P-L65

Transducer:	EU
-------------	----

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

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid,

Oblique, High Compound imaging, Wide View, Omni Directional M-mode

Additional Comments:

Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures(including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.

Subscript "h": Includes imaging for guidance of transrectal hiopsy. (PLEASE DO NOT WRITE BELOW THIS LING-CONTANUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

text
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

ﺮﺷ

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

System: Transducer:

EUP-L73S

And Control Concession Comers of ChildrenCHECK SIGA " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

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

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid, Contrast, Oblique, High Compound imaging, Omni Directional M-mode, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of-Beyice Evaluation (ODE)

✓ (Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K1102901

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

System: HI VISION Avius

Transducer: BUP-L74M

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	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
Cardiac	Intra-luminal
	Other (spec.)
	Cardiac Adult
	Cardiac PediatricTrans-esophageal (card.)Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid, Contrast, Oblique, High Compound imaging, Omni Directional M-mode, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Deyice Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive;, Abdominal, ENT,
and Radiological Devices

ોઇવ્યુવ 510(k) Number:

Prescription Use (Per 21 CFR 801.109)

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

System: HI VISION Avius EUP-LV74

Transducer:

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

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid,

Oblique, High Compound imaging, Omni Directional M mode, 3D imaging

Additional Comments:

Tubscript "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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(PLEASE DO NOT WRITE BELOW מחדש פוחדו رانا Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

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

System: HI VISION Avius

Transducer: EUP-O53T

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	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.)
	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid, Oblique, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
. and Radiological Devices

510(k) Number: K102901

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

System: HI VISION Avius

Transducer: EUP-054J

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	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 (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid,

Oblique, High Compound imaging, Omni Directional M-mode, Wide View

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

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

System: Transducer:

BUP-OL334

	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Annlication	Moda of Omeration

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	AbdominalIntra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic	P	P	P		P	P	P
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Fetal Imaging & Adult Cephalic
& Other	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 K093466

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

**Amplitude Doppler, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Deyjet Evaluation (ODE)

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Division of Reproductive, Abdominal, ENT,

and Radiological Devices 0240

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

System:

EUP-R54AW-19, -33 Transducer:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, 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).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K102901

{34}------------------------------------------------

System: HI VISION Avius

Transducer: EUP-S50A

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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.)
	Neonatal Cephalic
Fetal Imaging& Other	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 (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.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Contrast, Omni Directional M-mode, Tissue Doppler imaging

Additional Comments:

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

	Subscript "b": Includes imaging of organs and structures exposed during surgery
	(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

WRITE BELOW ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ ההגר Concurrence of CDRH, Office of Device Evaluation (ODE)

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and Radiological Devices

{35}------------------------------------------------

System:

Transducer: EUP-S52

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	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
Fetal Imaging& Other	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	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Omni Directional M·mode, Tissue Doppler imaging

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k) Number:

· Prescription Use (Per 21 CFR 801.109)

{36}------------------------------------------------

System: HI VISION Avius EUP-S70

Transducer:

Clinical Application			Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD (	GWD	ColorDoppler	Combined*(Spec.)	Other **(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	b	P	P	P	P	. Б
	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
Fetal Imaging	Adult Cephalic	P	P	P	P	P	P	P
& Other	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	Peripheral vessel	P	P	P	P	b	P	P
Vessel	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Contrast, Omni Directional Mrmode, 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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Reproductive, Abdominal, ENT,
and Radiological Devices

{37}------------------------------------------------

System: Transducer: EUP-U533

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography, Torapezoid, Oblique, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

1 (Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

K10290 510(k) Number:

{38}------------------------------------------------

System: Transducer:

EUP-V53W

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	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	Peripheral vessel
Vessel	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, Real Time Tissue Elastography,

. Contrast, High Compound imaging, Wide View

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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Reproductive, Abdominal, ENT,
and Radiological Devices

{39}------------------------------------------------

System: Transducer:

EUP-VV531

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Intended use . Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows-

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, High Compound imaging, 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, penis. Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of transrectal biopsy.

Subscript "f": Includes imaging for guidance of transvaginal biopsy. Subscript "g": For pediatric patients.

Includes imaging for guidance of transrectal biopsy. Subscript "h":

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Radiological Devices
510(k) Number: K102901

{40}------------------------------------------------

System: HI VISION Avius

EUP-VV731 Transducer:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

N = new indication. P = previously cleared in K093466

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

** Amplitude Doppler, Harmonic Imaging, High Compound imaging, 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, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of transrectal biopsy.
Subscript "f":	Includes imaging for guidance of transvaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for guidance of transrectal biopsy.
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division of Reproductive, Abdominal, ENT,
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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.