MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER

• K Number: K013722
• Device Name: MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
• Manufacturer: HITACHI MEDICAL CORP.
• Date Cleared: 2002-02-11 ( 94 days)
• Product Code: IYN
• Regulation Number: 892.1550

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: N = new indication. *Combination of each operating mode, B, M, PWD, CWD and Color Doppler. ** Amplitude Doppler, Harmonic Imaging and 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.

Device Description

The Imagin 2011 0000 Diagnoons aging system capable of the following operating pulsed Doppler und palsed continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound imaging system with various operating modes and imaging capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or other sections.

Therapeutic

No
The intended use and device description clearly state its purpose is for "Diagnostic ultrasound imaging or fluid flow analysis," indicating it is used for diagnosis, not treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis if the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "imaging system" capable of various ultrasound operating modes, implying the presence of hardware components necessary for generating and receiving ultrasound waves and processing the resulting signals into images.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis if the human body". This describes a device that is used to visualize structures and processes within the living human body.
• Device Description: The device description details the capabilities of an ultrasound imaging system, including various Doppler modes and imaging techniques. These are all methods for generating images and analyzing blood flow in vivo.
• Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, disease, or condition. The provided information does not mention any analysis of specimens.

Therefore, this device falls under the category of medical imaging devices used for diagnostic purposes in vivo, not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

90 IYN, 90 IYO, 90 ITX

Device Description

Device Description The Imagin 2011 0000 Diagnoons aging system capable of the following operating pulsed Doppler und palsed continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Pulsed Doppler, Pulsed Continuous Wave Doppler, Color Flow (including Amplitude Doppler), Harmonic Imaging, 3D Imaging

Anatomical Site

Ophthalmic, 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, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

K013722

FEB 1 1 2002

SUMMARY OF SAFETY AND EFFECTIVENESS Hitachi EUB-8500 Diagnostic Ultrasound Scanner

Device Description

Device Description The Imagin 2011 0000 Diagnoons aging system capable of the following operating pulsed Doppler und palsed continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.

Safety

As a Track 3 ultrasound device, the Hitachi EUB-8500 Diagnostic Ultrasound Scanner As a Track J unrasound corros, the al-Time Display of Thermal and Mechanical Acoustic Comput Indices on Diagnostic Ultrasound Equipment (1992)", published by NEMA as Output Indices on Diagnoons Charactic outputs, the Hitachi EUB-8500 Diagnostic OD 3. With respect to millies with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the Hitachi EUB-8500 Diagnostic Ultrasound Scanner is Whill regula to general barby, 60601-1 (1998) Medical Electrical Equipment, Part 1, General Requirements for Safety.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Mr. Walter Weyburne Regulatory Affairs Hitachi Medical Corporation of America 660 White Plains Road TARRYTOWN NY 10591

Re: K013722

Trade Name: EUB-8500 Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: 90 ITX Regulatory Class: II Dated: January 24, 2002 Received: January 25, 2002

Dear Mr. Weyburne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include are general ochilers pro 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 EUB-8500 Diagnostic Ultrasound Scanner, as described in your premarket notification:

Transducer Model Number

EUP-B314

2

EUP-C514
EUP-ES322
EUP-ES52M
EUP-ES533
EUP-F531
EUP-L54M
EUP-L53S
EUP-OL334
EUP-R53W
EUP-S50
EUP-TC3
EUP-U533
EUP-V53W

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. may pacifical 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 or mry recent 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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

3

Page 3 - Mr. Weyburne

predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please If you desire specific at [phone]. Additionally, for questions on the contact the Office of Ochipitation at (vice, please contact the Office of Compliance at (301) 594promotion and acroitising or your tion entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the notication (2) Order and the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

David C. Slayton

hr

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

4

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 Imaging
& Other	Fetal	N	N	N	N	N	N	N
		Abdominal	Na	Na	Na	Na	Na	Na	Na
		Intra-operative (Spec.)	Nb	Nb	Nb		Nb	Nb	Nb
		Intra-operative (Neuro.)	N	N	N		N	N	N
		Laparoscopic	N	N	N		N	N	N
		Pediatric	N	N	N	N	N	N	N
		Small Organ (Spec.)	Nd	Nd	Nd		Nd	Nd	Nd
		Neonatal Cephalic	N	N	N		N	N	N
		Adult Cephalic	N	N	N	N	N	N	N
		Trans-rectal	Nh	Nh	Nh		Nh	Nh	Nh
		Trans-vaginal	Nf	Nf	Nf		Nf	Nf	Nf
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skel. (Convent.)	N	N	N		N	N	N
		Musculo-skel. (Superfic.)	N	N	N		N	N	N
		Intra-luminal
		Other (spec.)
	Cardiac	Cardiac Adult	N	N	N	N	N	N	N
		Cardiac Pediatric	N	N	N	N	N	N	N
		Trans-esophageal (card.)	Ng	Ng	Ng		Ng	Ng	Ng
		Other (spec.)
	Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	N	N
		Other (spec.)

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

N = new indication.

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

** Amplitude Doppler, Harmonic Imaging and 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 "b": | Includes imaging of organs and structures exposed during surgery |
| 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)

David A. Seymore

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

510(k) Number: K013239

5

System: EUB-8500 EUP-B314 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	N	N	N		N	N	N
	Abdominal	Na	Na	Na		Na	Na	Na
	Intra-operative (Spec.)	Nb	Nb	Nb		Nb	Nb	Nb
	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.

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

** Amplitude Doppler and 3D Imaging.

Additional Comments:

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

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

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

Includes imaging for guidance of transvaginal biopsy. Subscript "f":

For pediatric patients. Subscript "g":

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)

K

David G. Norman
(Division Sign-off)

Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number: K113223

6

System:	EUB-8500
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	N	N	N		N	N	N
	Abdominal	Na	Na	Na		Na	Na	Na
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Spec.)	Nd	Nd	Nd		Nd	Nd	Nd
Fetal Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication.

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

** Amplitude Doppler, Harmonic Imaging and 3D 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)

David A. Nyberg
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K013722

7

System: Transducer:

EUB-8500 BUP-ES322

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.)
	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.)	N	N	N		N	N	N
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication.

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

** Amplitude Doppler and 3D Imaging.

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (including am nincente sis)

| 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 MN. CONNING ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Severson

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

510(k) Number: K101329

8

System: EUB-8500 Transducer:

EUP-ES52M

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

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

N = new indication.

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

** Amplitude Doppler and 3D Imaging.

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": lincluding am 13 oial

| 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 CINE CONTINUE ON ANOTHER PAGE IF NEEDED)

David A. Symon

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

510(k) Number: K014553

9

System:
Transducer:

EUB-8500 EUP-ES533

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.)	Ng	Ng	Ng		Ng	Ng	Ng
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N = new indication.

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

** Amplitude Doppler and 3D 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. |

Tip #1: Includes language for guidance or contextual clarity.

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

Javid A. Begson

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

510(k) Number: K050934

10

System:	EUB-8500
Transducer:	EUP-F531

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

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N
	Intra-operative (Spec.)	Nb	Nb	Nb		Nb	Nb	Nb
	Intra-operative (Neuro.)	N	N	N		N	N	N
	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Spec.)	Nc	Nc	Nc		Nc	Nc	Nc
	Neonatal Cephalic	N	N	N		N	N	N
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal	N	N	N		N	N	N
	Trans-vaginal	N	N	N		N	N	N
	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	N	N	N		N	N	N
Vessel	Other (spec.)

N = new indication.

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

** Amplitude Doppler and 3D Imaging.

Additional Comments:

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

Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, 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)

David A. Nyberg

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

510(k) Number: KC103723

11

System: Transducer:

EUB-8500 EUP-L54M

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	Na	Na	Na		Na	Na	Na
	Intra-operative (Spec.)
	Intra-operative (Neuro.)	N	N	N		N	N	N
	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Spec.)	Nd	Nd	Nd		Nd	Nd	Nd
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	N	N	N		N	N	N
	Musculo-skel. (Superfic.)	N	N	N		N	N	N
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N	N
	Other (spec.)

N = new indication.

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

** Amplitude Doppler and 3D 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 BE CONTINUE ON ANOTHER PAGE IF NEEDED)

Varish A. Seymm

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

510(k) Number: K061222

12

System:
Transducer:

EUB-8500 EUP-L53S

	"-tended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Comments of the consisted on the consisted on the consisted on the controlled of the contribution of the first
Company of Children Company of Children Company of Children Comments of Children	THE VIEW THE LEAST CO-ACCLASS

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	Na	Na	Na		Na	Na	Na
	Intra-operative (Spec.)
	Intra-operative (Neuro.)	N	N	N		N	N	N
	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ (Spec.)	Nd	Nd	Nd		Nd	Nd	Nd
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	N	N	N		N	N	N
	Musculo-skel. (Superfic.)	N	N	N		N	N	N
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N	N
	Other (spec.)

N = new indication.

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

** Amplitude Doppler and 3D Imaging.

Additional Comments:

Additional Comments.
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "h". ns and structures exposed during surgery maging of orga 1.5.7.1.5

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

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

Emrich A. Seymore

---

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: K973122

13

System: Transducer:

EUB-8500 EUP-OL334

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: 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
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic	N	N	N		N	N	N
	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.

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

** Amplitude Doppler and 3D Imaging.

Additional Comments:

Subscript "A". Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures 8.99 14.9

(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)

Daniel A. Bynam

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

510(k) Number: `K043522

14

System:
Transducer:

EUB-8500 EUP-R53W

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	N	N	N		N	N	N
	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.

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

** Amplitude Doppler and 3D 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)

Daniel A. Sgroi

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

510(k) Number: K013712

15

System: Transducer:

EUB-8500 BOP-S50

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

N = new indication.

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

** Amplitude Doppler, Harmonic Imaging and 3D Imaging.

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": 15.732

	(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 DINE CONVINUE ON ANOTHER PAGE IF NEEDED)

David A. Seymore

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

510(k) Number: K101372

16

System: Transducer:

EUB-8500 EUP-TC3

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

N = new indication.

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

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 BIN CONNULON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Varril A. deason

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

510(k) Number: K103223

17

System: EUB-8500 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	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	Nh	Nh	Nh	Nh	Nh	Nh	Nh
	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.

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

** Amplitude Doppler and 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)

David A. Dyson
Division Sign Off

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

510(k) Number: K032272

18

System: Transducer: EUB-8500

EUP-V53W

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

N = new indication.

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

** Amplitude Doppler and 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.

script 1. Increase imaging for guidance of treatment biopsy.

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

Thrist G. Inam

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

510(k) Number: K013621