Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system and explicitly states that the control and image processing hardware and base software are identical to the predicate device, with no mention of AI or ML capabilities.

Therapeutic

No
The device is described as being used for "diagnostic ultrasound evaluation" and functions like "display the computed image or derived Doppler data," indicating its purpose is to diagnose conditions rather than treat them.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic ultrasound evaluation."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes ultrasound transducers, a computer system, and a video monitor, which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
Device Function: The HI VISION Ascendus is an ultrasound system. It uses sound waves to create images of internal body structures within the body. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states "diagnostic ultrasound evaluation" of various anatomical sites. This is an in-vivo (within the living body) diagnostic method.
Device Description: The description details components like transducers, a computer system for signal analysis, and a monitor to display images. These are characteristic of an imaging system, not an IVD.

Therefore, the HI VISION Ascendus is a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, 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.

The Modes of Operation of the HI VISION Ascendus 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, Real Time Tissue Elastography, and Real Time Virtual Sonography.

Product codes

1YN, 1YO, ITX

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

Mentions image processing

The control and image processing hardware and the base elements of the system software are identical to the predicate device.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Intra-luminal, Gynecology, Urology

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Trained personnel (doctor, sonographer, etc.)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

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

Not Found

Predicate Device(s)

HI VISION Preirus Diagnostic Ultrasound Scanner (K093466)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371
ph: (330) 425-1313
fax: (330) 963-0749 | SEP 27 2011 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Douglas J. Thistlethwaite | |
| Date: | March 3, 2011 | |

Submitter Information

Device Name

Classification Name:	System, Imaging, Pulsed Doppler, Ultrasonic
Classification Number:	90-IYN
Trade/Proprietary Name:	HI VISION Ascendus Diagnostic Ultrasound Scanner
Predicate Device(s):	HI VISION Preirus Diagnostic Ultrasound Scanner (K093466)

Device Intended Use

The HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, 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.

The Modes of Operation of the HI VISION Ascendus 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, Real Time Tissue Elastography, and Real Time Virtual Sonography.

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.

1

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 adiacent transducer from the various tissues along 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 HI VISION Ascendus 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)

Attachment

ATTACHMENT	POSITION
Declaration of Conformity with Design Controls	1

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle. The bird is depicted with simple, curved lines, giving it a modern and abstract appearance.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Doug Thistlethwaite Manager. Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OF 44087

SEP 27 2011

Re: K110673

Trade/Device Name: HI VISION Ascendus Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN. 1YO. and ITX Dated: August 29, 2011 Received: August 31. 2011

Dear Mr. Thistlethwaite:

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 ffor 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 Ascendus Diagnostic Ultrasound Scanner, as described in your premarket notification:

Transducer Model Number

EUP-B512	EUP-CV524	EUP-L53L
EUP-B514	EUP-CV714	EUP-L54MA
EUP-B715	EUP-CV724	EUP-L65
EUP-C511	EUP-ES52E	EUP-L73S
EUP-C514	EUP-ES52M	EUP-L74M
EUP-C524	EUP-F334	EUP-L76
EUP-C532	EUP-F531	EUP-LV74
EUP-C715	EUP-L52	EUP-O53T
EUP-CC531	EUP-L53	EUP-O54J

3

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                                                                                                                                                                                           |                                                                                                                                                                                                          |

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 Tound in the Code of Federal Regulations. Title 21. Parts 800 to 895. In addition. FDA may publish further announcements concerning vour 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 vour 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/CDRF/CDRHOffices/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 Lauren Hefner at (301) 796-6881

Sincerely Yours.

Mary S. Pottle

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

4

Indications for Use

510(k) Number (if known): KUO673

Device Name: HI VISION Ascendus Diagnostic Ultrasound Scanner

Indications For Use:

The HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, 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, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

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

× 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)

Mary S Patel

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Kil0623

Page 1 of __

5

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

** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography

Additional Comments:

System:

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)

Mary Settle
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devic

510(k) Number: K110673

6

System: Transducer

EUP-B512

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	Color
Doppler	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 Adult
Cardiac	Cardiac Pediatric
	Trans esophageal (card.)
	Other (spec.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, Real Time Virtual Sonography

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)

Mary Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number: K110673

7

Transducer: EUP-B514

System:

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

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

N = new indication. P = previously cleared in K093466

Other (spec.)

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

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

Additional Comments:

Vessel

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures

	(including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, 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)

CON ANU' Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Sadoff
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110673

8

System: Transducer:

EUP-B715

| Clinical Application | | Mode of Operation | | | | | | Other**
(Spec.) |
|---------------------------|------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | 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 (Color Flow Angiography), 3D Imaging, Real Time Virtual Sonography

Additional Comments:

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

| Subscript "b": | Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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)

Manys Petty
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110623

9

Transducer EUP-C511

System:

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	Color
Doppler	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	Adult Cephalic
& 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
	Cardiac Pediatric	P	P	P		P	P	P
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	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 and Color Doppler.

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

Additional Comments:

Subscript "a". Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures

(including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, 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)

Mura S. Patil
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number: K110673

10

System: Transducer:

EUP-C514

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	Color
Doppler	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, Real Time Virtual Sonography

Additional Comments:

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

| Subscript "b": | Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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 RELOW Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number: K110673

11

Transducer EUP.C524

System:

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

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

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler (Color Flow Angiography), 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mass Patil
(Division Sign-Off

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number:

12

System: Transducer:

EUP-C532

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other **
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	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	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	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 (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography

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)

Mary S Patel
(Division Sign-Off)

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

510(k) Number: K110623

13

System: Transducer:

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	Color
Doppler	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, Real Time Virtual Sonography

Additional Comments

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures

	(including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, 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)

Mary S. Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Device

510(k) Number: K110673

14

System:

Transducer EUP-CC531

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

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

Additional Comments:

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

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

(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, 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)

Mary Patel
(Division Sign-Off)

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

510(k) Number: K110623

15

System: Transducer EUP-CV524

		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	Color
Doppler	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, 4D 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) |

ATTE DE Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Postel
(Division/Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number

16

System: Transducer:

EUP-CV714

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, 4D 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. |

(BEEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTHER FAGE IF NEEDED! Concurrence of CDRH, Office of Device Evaluation (ODE)

Mayshath
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Device

510(k) Number: K110673

17

Transducer EUP-CV724

System:

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	Color
Doppler	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, 4D Imaging

Additional Comments:

Subscript "a". Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures

	(including amniocentesis).
	Subscript "b": Includes imaging of organs and structures exposed during surgery
	(excluding neurosurgery and laparoscopic procedures).
	Subscript "c": Includes thyroid, parathyroid, breast, scrotum, 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)

Mary S. Protol
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number: K110623

18

System' Transducer:

EUP-ES52E

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)	P	P	P	P	P	P	P
	Other (spec.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, 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 TH Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Postel
(Division Sign-Off)

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

510(k) Number: K110672

19

System: Transducer

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	Color
Doppler	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, 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)

AKLE RELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mains Postel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number

20

System: Transducer:

EUP-F334

	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	Color
Doppler	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
& 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.)
Peripheral	Peripheral vessel	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 and Color Doppler.

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

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures of 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)

Mary S. Patil
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number

21

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM HI VISION Ascendus EUP-F531 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

System: Transducer

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	Color
Doppler	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
& 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.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler (Color Flow Angiography), 3D Imaging

Additional Comments

	Subscript a . Includes imaging for guidance of percutaneous blopsy of abdominal organs and structures

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.

החשבה ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Stotel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110673

22

System: Transducer:

EUP-L52

	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	Color
Doppler	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	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.)
	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.)

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler (Color Flow Angiography), 3D 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)

Mary Stotl
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K110673

23

Transducer EUP-L53

System :

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

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

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler (Color Flow Angiography), 3D 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)

-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Potter
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K110673

24

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

HI VISION Ascendus

Transducer: EUP-L53L

if

System:

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

** Combination of each operating mode, 2, 14, 17 and occep, Real Time Tissue Elastography

Additional Comments:

Aubicinal Collinents'
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)

Mary Patel
(Division Sign-Off)

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

510(k) Number: K110623

25

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM HI VISION Ascendus Transducer EUP-L54MA

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

N = new indication. P = previously cleared in K093466

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

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

Additional Comments:

System:

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)

Mary Sestef
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110673

26

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

HI VISION Ascendus System:

EUP-L65 Transducer:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography

Additional Comments:

	Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures
	(including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery
	(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, 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)

Mary S. Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT; and Radiological Devices

510(k) Number: K110673

27

System: Transducer:

EUP-L73S

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	Color
Doppler	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	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 and Color Doppler.

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

Additional Comments:

| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures
(including amniocentesis). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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. |

sucript a - 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)

Mary Shool
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110673

28

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: HI VISION Ascendus

Transducer: EUP-L74M

Clinical Application						Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	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	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	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 (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography

Additional Comments:

| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures
(including amniocentesis). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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. |

ipt "h". Includes imaging for guidance of transrectal biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEDI Subscript "h":

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110623

29

System Transducer

EUP-L75

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	Color
Doppler	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 Adult
Cardiac	Cardiac Pediatric
	Trans esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K093466

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

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

Additional Comments

| 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) |

AGE IF NEEDED પાય છે. Concurrence of CDRH, Office of Device Evaluation (ODE)

Mays Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110673

30

System: Transducer:

EUP-LV74

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography

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)

Mary Stotes
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K110673

.

31

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System · HI VISION Ascendus Transducer EUP-053T

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	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler (Color Flow Angiography), 3D 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)

Mary Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

32

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Transducer:

HI VISION Ascendus EUP-054J

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	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Spec.)
	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.)
Peripheral	Peripheral vessel	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 and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), 3D 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)

Mary Slater
(Division Sign-Off)

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

510(k) Number: K110673

33

System: Transducer EUP-0732T

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	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	P	P	P		P	P	P
	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D 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)

Mares Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110613

34

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Transducer:

HI VISION Ascendus EUP-OL334

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color.
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-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	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 (Color Flow Angiography), 3D 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 ANDTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Maus S. Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K110623

35

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM HI VISION Ascendus System Transducer: EUP-R54AW-19, -33

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



The same of the market of the market the many of the more of the comments of

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	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
Abdominal
Intra-operative (Spec.)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (Spec.)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral	P	P	P		P	P	P
	Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac	Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral
Vessel	Peripheral vessel
Other (spec.)

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler (Color Flow Angiography), 3D 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)

Mary S Potter
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K110673

36

System: Transducer

EUP-S50A

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

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 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 CDRH, Office of Device Evaluation (ODE)

Mary Slatel
(Division Sign-Off)

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

510(k) Number: K110673

37

System: Transducer:

EUP-S52

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	Color
Doppler	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	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	P	P	P	P	P	P	P
	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, CWD and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 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 CDRH, Office of Device Evaluation (ODE)

Mary Slattel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number: K110673

38

System: Transducer

EUP-S70

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	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
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.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K093466

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

**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 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) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Sooted
(Division Sign-Off)

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

510(k) Number:

39

System: Transducer

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	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic	P	P	P	P	P	P	P
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	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K093466

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

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

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

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

Mary Patel
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110673

40

System: Transducer

EUP-U533

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	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography

Additional Comments:

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

| Subscript "b": | Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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 RE Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Spadt
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K110673

41

System: Transducer

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	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic	P	P	P		P	P	P
	Fetal	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 Adult
Cardiac	Cardiac Pediatric
	Trans esophageal (card.)
	Other (spec.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography, 1 Real Time Virtual Sonography

Additional Comments:

Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures
	(including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery
	(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, 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)

Mary S Patil
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110673

42

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System:

HI VISION Ascendus Transducer EUP-VV531

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, 4D imaging

Additional Comments:

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

| | Subscript "b": | Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures). |
|--|----------------|---------------------------------------------------------------------------------------------------------------------------|
| | Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, 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)

Mary S. Ratis
(Division Sign-Off)

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

510(k) Number: K110673

43

System : Transducer: EUP-VV731

		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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	Color
Doppler	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.)
Peripheral
Vessel	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 (Color Flow Angiography), 3D Imaging, 4D imaging

Additional Comments:

Subscript "a" Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures

(including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, 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)

Mary S. Proth
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K110673

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 892.1550 Ultrasonic pulsed doppler imaging system.

Submitter Information

Device Name

Device Intended Use

Device Description

Function

Scientific Concepts

Physical and Performance Characteristics

Device Technological Characteristics

Conclusions

Attachment

Annual The Fits and any : 1 1 -4-4-4-4 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 155 - 10 ﻟ : :

l No. of Children and Charles a | r " " : ) I

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Indications for Use

510(k) Number (if known): KUO673

Device Name: HI VISION Ascendus Diagnostic Ultrasound Scanner

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

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

Transducer EUP-CC531

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

EUP-CV714

EUP-ES52E

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM HI VISION Ascendus EUP-F531 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM HI VISION Ascendus Transducer EUP-L54MA

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System · HI VISION Ascendus Transducer EUP-053T

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

HI VISION Ascendus EUP-054J

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

HI VISION Ascendus EUP-OL334

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM HI VISION Ascendus System Transducer: EUP-R54AW-19, -33

Additional Comments:

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

EUP-U533

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

HI VISION Ascendus Transducer EUP-VV531

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

Annual The Fits and any
:
1
1
-4-4-4-4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 155 - 10
ﻟ
:
:

l
No. of Children and Charles a | r " "
:
) I

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| r
I
1

l
|
| -