EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER by HITACHI MEDICAL CORP.

The provided text outlines the intended use and modes of operation for various transducers of the Hitachi EUB-6500 Diagnostic Ultrasound Scanner. It does not contain information about acceptance criteria for a specific outcome, nor does it describe a study proving the device meets particular performance metrics.

Instead, this document appears to be part of a 510(k) premarket notification to the FDA, detailing the intended uses for different transducers associated with the EUB-6500 system. The "E" and "P" notations in the tables indicate whether an intended clinical application and mode of operation was "Added under Appendix E" (meaning new for this submission) or "Previously Cleared" (referring to a previous submission, K013723).

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is a regulatory submission outlining intended uses, not a performance study.

Summary

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		05325
DEC 9	2005	HITACHI
		Basic Information
		and the contraction and the contribution of the consistent would be considered to the consideration of the contribution of the comments of the

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4.2.1	Manufacturers Name (Ultrasound Scanner):	Hitachi Medical Corporation
	Address:	Hitachi Kamakurabashi Bldg., 1-1-14Uchi-kanda, Chiyoda-kuTokyo 101-0047 Japan
	Corresponding Official:	Doug ThistlethwaiteManager, Regulatory Affairs
	Address:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087
	Telephone:	(330) 425-1313
4.2.2	Initial Distributor (Ultrasound Scanner) :	Hitachi Medical Systems America, Inc.
	Address:	1959 Summit Commerce ParkTwinsburg, Ohio 44087
	Telephone:	(330) 425-1313
4.2.3	Device Name:	EUB-6500 Diagnostic Ultrasound Scanner
4.2.4	Common Name:	Diagnostic Ultrasound Unit
4.2.5	Classification
	Regulatory Class:	Class II
	Review Category:	Tier II
		FR Number	Product Code
	Ultrasonic Pulsed Echo and Pulsed DopplerImaging System	892.1550	90-IYN
	Diagnostic Ultrasound Transducer	892.1570	90-ITX
4.2.6	Establishment Registration Number:	Hitachi Medical Corp. (Japan) 8030405Hitachi Medical Systems America, Inc. (USA) 1528028
4.2.7	514 Performance Standards:	None
4.2.8	Special Controls:	Special Report - to be filed at a later date
4.2.9	Prescription Status:	Prescription Device
4.2.10	Manufacturing Location (UltrasoundScanner):	Hitachi Medical Corporation - Kashiwa Works2-1 ShintoyofutaKashiwa-shi, Chiba-ken277-0804Japan
4.2.11	Sterilization Site(s):	N/A Device is not shipped as sterile.
4.2.12	Reason for Submission:	Modification to existing product

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle emblem.

DEC 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K053258

Trade Name: EUB-6500 Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 14, 2005 Received: November 22, 2005

Dear Mr. Thistlewaite:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection or exisi petities is substantially equivalent (for the referenced above and we have acterimine) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate connicted pror to thay 20, 1978, et assified in accordance with the provisions of the Amendinents, or to devices market Act (Act). You may, therefore, market the device, subject to rederal rood, Drug, and Cosment Prec (1. The general controls provisions of the Act include the general controls provisions of the isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for Tills delethination of Substantal equiltrasound Scanner, as described in your premarket notification:

Transducer Model Number

EUP-B514 EUP-C312T

EUP-C314G
EUP-C511

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EUP-C516	EUP-L65
EUP-C524	EUP-O53T
EUP-C532	EUP-R54A-19
EUP-CC531	EUP-R54A-33
EUP-CV524	EUP-R54AW-19
EUP-F334	EUP-R54AW-33
EUP-L34T	EUP-S50
EUP-L52	EUP-S50A
EUP-L53	EUP-S52
EUP-L53L	Fujinon SP711

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 aco'v) arols. Existing major regulations affecting your device of the subject to it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of I veceras concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Freast of advised that I Drivedants over device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of any I cuchar statutes and regulations and united to: registration and listing (21 Comply with an the 11et 3 requirements, 01); good manufacturing practice requirements as set Cr K Fall 807), labeling (21 CFR Part 820); and if applicable, the electronic a form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I the first device, you submit a postclearance special report. This report should contain complete the first device, you submit a postered anes arements based on production line devices, requested information, merading accused of the Center's September 30, 1997 "Information for Manufacturers In Appendix U, (cherosou) of the Senter to Clicksound Systems and Transducers." If the special Secking Marketing Orearans 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 This letter will anow you vot substantial equivalence of your device to a legally marketed nonfloation. The I Drivin a classification for your device and thus permits your device to proceed to market.

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Page 2 - Mr. Thistlethwaite

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours.

Nancy C brogdon

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

Enclosure(s)

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

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

P = Previously Cleared, K013723

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

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

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.

script II - Includes Imaging for guidance of transrectal biopsy.
PLEASE DO NOT WRITE BELOW

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

Nancy C. Broadon

(Division Sign Of Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number: K053258

Prescription Use

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System: Transducer:

EUB-6500 EUP-B514

				titended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
	A . A	1.4000 - 4.0000 - 4.4 4.00 - 4.0 4.0 - 4.4 4.4 - 4.4 4.4		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

E = Added under Appendix E

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

**Amplitude Doppler, Harmonic 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.

Nancy C. Hogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number: K053258

Prescription Use

{6}------------------------------------------------

System: Transducer: EUB-6500

EUP-C312T

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 & II)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	E	E	E		E	E	E
	Abdominal	Ea	Ea	Ea		Ea	Ea	Ea
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	E	E	E		E	E	E
	Small Organ (Spec.)	Ed	Ed	Ed		Ed	Ed	Ed
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

E = Added under Appendix E

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

**Amplitude Doppler, Harmonic 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)

Nancyc broydon
(Division Sign-Off)

Division of Reproductive, Abdominal, H and Radiological Devices

510(k) Number: K053258

Prescription Use

{7}------------------------------------------------

System: Transducer

EUB-6500 EUP-C314G

Intended use: Diagnostic ultrasound imaging of fluid flow analysis if the human body		Mode of Operation
Clinical Application		B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal	E	E	E		E	E	E
	Abdominal	Ea	Ea	Ea		Ea	Ea	Ea
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	E	E	E		E	E	E
	Small Organ (Spec.)	Ed	Ed	Ed		Ed	Ed	Ed
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

E = Added under Appendix E

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

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

Additional Comments:

Additional Comments:
Subscript "a". Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures acial

(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.

pt "h"." Theludes maging for guidance of transiccan nepoly on ANG (ODE) WILL BELO ... Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Livision Sign-Off. I)ivision of Reproductive, Abdom and Radiological Device

510(k) Number: K053258

Prescription Use

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

System: Transducer: EUB-6500

EUP-C511

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

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

E = Added under Appendix E

E = Added under Appendix E
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.

**Amplitude Doppler, Harmonic Imaging.

Additional Comments:

ments.
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)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomi and Radiological Devices

510(k) Number

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

System: Transducer: EUB-6500

EUP-C516

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

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

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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.

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive and Radiological Device

510(k) Number: K053258

... what might have been?
... what might be now?

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

System: Transducer:

EUB-6500 EUP-C524

Intended use: Diagnostic ultrasound imaging or fluid flow analysis		Mode of Operation
Clinical Application		B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal	E	E	E		E	E	E
	Abdominal	E	E	E		E	E	E
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	E	E	E		E	E	E
	Small Organ (Spec.)	E	E	E		E	E	E
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

E = Added under Appendix E

*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.

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

Nemarc Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number: K053258

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

System: Transducer:

EUB-6500 EUP-C532

Intended use: Diagnostic ultrasound imaging or fluid flow analysis in the human body as follows:		Mode of Operation
Clinical Application		B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Ea	Ea	Ea		Ea	Ea	Ea
	Intra-operative (Spec.)	Eb	Eb	Eb		Eb	Eb	Eb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	E	E	E		E	E	E
	Small Organ (Spec.)	Ed	Ed	Ed		Ed	Ed	Ed
	Neonatal Cephalic	E	E	E		E	E	E
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	E	E	E		E	E	E
	Other (spec.)

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

E = Added under Appendix E

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

**Amplitude Doppler, Harmonic Imaging.

Additional Comments:

Includes imaging for guidance of percutancous 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.

Nancy C. Broglon
(Division Sign-Off)

(Division Sign Off, Division of Reproductive, Abdominal, for and Radiological Devices

510(k) Number: K053258

Description Code

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

System: Transducer:

EUB-6500 EUP-CC531

Intended use: Diagnostic ultrasound imaging or fluid flow analysis in the human body as follows:Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal	E	E	E		E	E	E
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal	Ee	Ee	Ee		Ee	Ee	Ee
	Trans-vaginal	Ef	Ef	Ef		Ef	Ef	Ef
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

tended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as followsr.

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number: K053258

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

System: Transducer:

EUB-6500 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	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	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.)	N	N	N	N	N	N	N
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication.

*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 amniorentesis)

	(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)

Nancy C Hodgson
(Division Sign-Off)

Division of Reproductive, Abdom and Radiological Devices

510(k) Number: K053258

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

System: Transducer:

EUP-F334

EUB-6500

istended use. Diagnostic ultrasound imaging or find flow analysis if the human body as follows.
-------------------------------------------------------------------------------------------------	--	--

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

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomin and Radiological Devices

510(k) Number: K053258

✓

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

System: Transducer:

EUB-6500 EUP-L34T

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as followsClinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Ea	Ea	Ea		Ea	Ea	Ea
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	E	E	E		E	E	E
	Small Organ (Spec.)	Ed	Ed	Ed		Ed	Ed	Ed
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	E	E	E		E	E	E
	Musculo-skel. (Superfic.)	E	E	E		E	E	E
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	E	E	E		E	E	E
	Other (spec.)

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

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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)

Manue Bergdon
Division Sign-Off

(Division pign-Off) Division of Reproductive, Abdominal, ENF. and Radiological Devices

510(k) Number: 4053258

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

System: Transducer: EUB-6500

EUP-L52

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

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

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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)

Nancy C. Croydon
Division Sign-Off

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number: K053258

✓

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

System: Transducer: EUB-6500

EUP-L53

Intended use: Diagnostic ultrasound imaging or fluid flow analysis in the human body as follows:Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Ea	Ea	Ea		Ea	Ea	Ea
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	E	E	E		E	E	E
	Small Organ (Spec.)	Ed	Ed	Ed		Ed	Ed	Ed
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	E	E	E		E	E	E
	Musculo-skel. (Superfic.)	E	E	E		E	E	E
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	E	E	E		E	E	E
	Other (spec.)

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

E = Added under Appendix E

*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.

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomin and Radiological Devices

510(k) Number: K052258

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

System: Transducer:

EUB-6500 EUP-L53L

'ntended use' Diagnostic ultrasound imaging or fluid flow analvsis if the human body as follows

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

E = Added under Appendix E

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

**Amplitude Doppler, Harmonic 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)

Nancy Chogdon

Division Sign Off Division of Reproductive, Abdominal, for and Radiological Devices

510(k) Number: K053258

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

System: Transducer:

EUB-6500 EUP-L65

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

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

E = Added under Appendix E

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

**Amplitude Doppler, Harmonic 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.

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, EA and Radiological Devices

510(k) Number: K053258

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

System: Transducer:

EUB-6500 EÜP-O53T

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

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

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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.

Nancy Brogdon
(Division Sign Off)

Division of Reproductive, and Radiological Dev

510(k) Number: K053258

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

System: Transducer:

EUB-6500 EUP-R54A-19

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

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

E = Added under Appendix E

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

**Amplitude Doppler, Harmonic Imaging.

Additional Comments:

Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": 10101

	(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.

Nancy C Brogdon
Division Sign-Off

Division of Reproductive, Abdom: and Radiological Device

510(k) Number: KA053258

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

System: Transducer:

EUB-6500 EUP-R54A-33 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

			' ~tended use: Diagnostic ultrasound imaging or fluid flow analysis if the human bodv as follows

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

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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.

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

510(k) Number: K053258

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

System: Transducer:

EUB-6500 EUP-R54AW-19

Intended use: Diagnostic ultrasound imaging or fluid flow analysis in the human body as follows:		Mode of Operation
Clinical Application						Color	Combined*	Other**
General	Specific	B	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal	E	E	E		E	E	E
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

ostic ultrasound imaging or fluid flow analysis if the human body as follows ni

E = Added under Appendix E

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

**Amplitude Doppier, Harmonic 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)

Nancy C Hodgson

(Division Sign-C Division of Reproductive, Abdominal, B and Radiological Devices

510(k) Number: K053258

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

System: Transducer

EUB-6500 EUP-R54AW-33

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

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

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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)

Nancy C. Hogdon
(Division Sign-Off)

Division of Reproductive, Abdom and Radiological Devices

510(k) Number: K053258

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

System: Transducer: EUB-6500

EUP-S50

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

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

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic Imaging.

Additional Comments

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

	(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.

Nancy Brogdon

(Division Sign-0 Division of Reproductive, Abdominal, EN and Radiological Devices

510(k) Number: A053258

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

System: Transducer:

EUB-6500 EUP-S50A

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

E = Added under Appendix E

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

**Amplitude Doppler, Harmonic 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.

Nancy C Brogdon

Division Sign Off) Division of Reproductive, Abdominal, ENA and Radiological Devices

510(k) Number: K053258

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

System: Transducer: EUB-6500

EUP-S52

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	Combined*	Other**
(Track I only)	(Tracks I & III)					Doppler	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	E	E	E	E	E	E	E
	Small Organ (Spec.)	Ec	Ec	Ec	Ec	Ec	Ec	Ec
	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	E	E	E	E	E	E	E
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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.

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

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdommal, E. and Radiological Devices

510(k) Number: K053258

✓

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

System: Transducer

EUB-6500 Fujinon SP711

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:		Mode of Operation
Clinical Application
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal	E
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

tended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as followsт.

E = Added under Appendix E

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

** Amplitude Doppler, Harmonic 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.

Includes imaging for guidance of transrect (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdom mal H and Radiological Devices

510(k) Number: K1053258

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.