Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver, pancreas and gall bladder), Intraoperative Neurological (Neurological burr hole), Pediatric, Small Organ (breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification correction letter for the Aloka SSD-5000 V5.0 Ultrasound System, dated December 8, 2003. It primarily focuses on correcting the list of transducer model numbers and reiterating the "Indications for Use" for the device and various transducers.

Based on the provided information, there is no acceptance criteria or study data in this document that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, etc. This document is an FDA clearance letter, which means the device has been deemed substantially equivalent to a predicate device.

Instead, the tables presented in the document specify the intended use and modes of operation for the ultrasound system and its various transducers across different clinical applications. The "P" (previously cleared by FDA) and "E" (added under Appendix E) in the tables indicate which indications for use have already been cleared or are being added in this submission, rather than reporting performance metrics.

Therefore, since the request asks for specific details about acceptance criteria and a study that proves the device meets those criteria, and this document does not contain that type of information, I must state that the requested information cannot be extracted from the provided text.

Here is a breakdown of why each point of your request cannot be fulfilled:

A table of acceptance criteria and the reported device performance: This document does not contain acceptance criteria (e.g., target sensitivity, specificity, accuracy) nor reported device performance metrics from a study. It only lists the "Intended Use" for various clinical applications and the compatible "Modes of operation" for the ultrasound system and its transducers.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is present. The document is an administrative FDA clearance, not a clinical study report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No information regarding experts, ground truth establishment, or their qualifications is provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Since no test set is mentioned, no adjudication method is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This document predates widespread AI in medical imaging and does not contain any MRMC study data or AI-related performance metrics.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No information on standalone algorithm performance is included.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth information is mentioned.
The sample size for the training set: No training set or its size is mentioned.
How the ground truth for the training set was established: No information regarding the establishment of ground truth for a training set is provided.

In summary, this document is an FDA regulatory clearance, not a scientific or clinical study report. It confirms the device's substantial equivalence to previously cleared devices for its stated intended uses, but it does not detail specific performance criteria or the studies used to meet them in the way clinical studies for AI/CAD products typically would.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 8 - 2003

Mr. Richard J. Cehovsky RA/QA Coordinator Aloka Co., Ltd. 10 Fairfield Boulevard WALLINGFORD CT 06492-7502

Re: K033311

Trade/Device Name: Aloka SSD-5000 V5.0 Ultrasound System 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 Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: November 11, 2003 Received: November 17, 2003

Dear Mr. Cehovsky:

This letter corrects our substantially equivalent letter of October 29, 2003 regarding the Aloka SSD-5000 V5.0 Ultrasound System. Transducer Model Number: UST-52109 located on page 69 of the original 510(k) was inadvertently omitted from the list below and is now being added.

Transducer Model Numbers

ASU-67-10/7.5	UST-5281-5	UST-5712
UC140P-AL5	UST-5284-2.5	UST-5713T
UCT140-AL-5	UST-5285-3.5	UST-9101-7.5
UST-533	UST-5293-5	UST-9102-3.5
UST-547	UST-5294-5	UST-9104-5
UST-672-5/7.5	UST-5296	UST-9114-3.5
UST-675P	UST-5297	UST-9115-5
UST-995-7.5	UST-5524-5	UST-9118
UST-987-7.5	UST-5524-7.5	UST-9119
ASU-1000C-3.5	UST-5526L-7.5	UST-9120
ASU-1001	UST-5531	UST-9121
ASU-1002	UST-5534T-7.5	UST-9126
ASU-1005	UST-5536-7.5	UST-9128
UST-2265-2	UST-5539-7.5	UST-52104
UST-5268P-5	UST-5543	UST-52108
UST-5271S-5	UST-5545	UST-52109
UST-5280-5	UST-5548	UST-MC11-873

{1}------------------------------------------------

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (ffor the indice 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 Press natio Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general contrals provisions of the Act include requirements for annual registration, listing of devices, good manufacturing protise, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish fortuner announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set for cract only, in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Complance at (301) 594-4654. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufactures, International and Consumer Assistance at their toll free number (800) 638-2041 or at (31) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

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

{2}------------------------------------------------

4.3.1

Diagnostic Ultrasound Indications for Use Form SSD-5000 V5.0

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P		P	P		See Below
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological		P	P	P			P		See Below
Pediatric		P	P	P		P	P		See Below
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic		P	P	P		P	P		See Below
Adult Cephalic		P	P	P		P	P		See Below
Cardiac		P	P	P		P	P		See Below
Transesophageal		P	P	P		P	P		See Below
Transrectal		P	P	P		P	P		See Below
Transvaginal		P	P	P		P	P		See Below
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic		P	P	P		P	P		See Below
Musculo-skeletalConventional		P	P	P		P	P		See Below
Musculo-skeletalSuperficial		P	P	P		P	P		See Below
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWDIntraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.

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

David A. Legum

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number .

{3}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form ASU-67-10/7.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		See Below
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.

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

zicion Sign Off

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

{4}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		P	P	P		P	P		See Below
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.

Intraoperative applications: liver, pancreas and gall bladder

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

David A. Seymann

Concurre

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

{5}------------------------------------------------

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

						Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		P	P	P		P	P		See Below
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Intraoperative applications: include liver, pancreas and gall bladder.

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

David A. Symm

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) ( Division of Reproductive, Abdominal and Radiological Devices, 510(k) Number_

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		E	E	E		E	E		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD,B/Bflow?PWD

Intraoperative applications: liver, pancreas and gall bladder.

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

David A. Glynn

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		E	E	E		E	E		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E	E		E	E		See Below
Neonatal Cephalic		E	E	E		E	E		See Below
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small Organ applications: breast, testes, thyroid

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

David A. Senger

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		See Below
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.

Intraoperative applications: abdominal, bladder, pancreas and gall bladder.

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

David A. Lehman

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) /
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033311

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

510(k)

Diagnostic Ultrasound Indications for Use Form UST-675P

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		See Below
Transvaginal		P	P	P		P	P		See Below
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic					,
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

David A. Hygum

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number_

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.

Applications: Intraoperative: liver, pancreas and gall bladder. Small Organ: breast, testes, thyroid. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Daniel A. Serum

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P		P	P		See Below
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Lapa:oscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Intraoperative applications: include liver, pancreas and gall bladder.

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

David A. Lynn
(Division Sign-Off) Concurrence

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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

Diagnostic Ultrasound Indications for Use Form ASU-1000C-3.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P		P	P		See Below
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

David A. Legum

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 29 510(k) Number _

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P		P	P		See Below
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

David A. Legan

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _ 30

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P		P	P		See Below
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		P	P	P		P	P		See Below
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Daniel A. Seymore
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		E	E	E		E	E		See Below
Abdominal		E	E	E		E	E		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

David A. Degnan
Division Sign Off

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K03331

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

OS1-220J-2

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					P				See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiologia D
Pr

and Radiological Devices 510(k) Number_

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological		P	P	P		P	P		See Below
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P		P	P		See Below
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Neurological burr hole, Intraoperative: liver, pancreas, gall bladder.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) -Preseription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

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

UST-5271S-5

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric	P	P	P	P		P	P		See Below
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P		P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P		P	P		See Below
Transesophageal	P	P	P	P		P	P		See Below
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE) -Prescription Use (Per 21 CFR 801.109)

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

UST-5281-5

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P		P	P		See Below
Adult Cephalic		P	P	P		P	P
Cardiac		P	P	P		P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KO33311

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033311

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular										1
Laparoscopic					1
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Segrem
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P		P	P		See Below
Adult Cephalic
Cardiac		P	P	P		P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					I
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Neonatal

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

David A. Segomm

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Anason Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number_

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P		P	P		See Below
Adult Cephalic
Cardiac		P	P	P		P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Neonatal

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

David A. Seymann

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

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

UST-5297

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Daniel A. Ingram

் செங்காள் Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices +1 14 510(k) Number _

بر مکي ريغيراس ت

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

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

Clinical Application	Modes of operation
A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Small Organ applications: breasts, testes and thyroid

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Lyon

innsion Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)	P	P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Small Organ applications: Breasts, testes and thyroid (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Con Sign-Off) െറ ! Reproductive, Abdomina

് അവിരിച്ചവാഹം o ! /k) Number __

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic		P	P	P		P	P		See Below
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD Intraoperative: Liver, pancreas, gall bladder

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Severson

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Intraoperative applications: include liver, pancreas and gall bladder.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Legman
(Division Sign-Off)

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Intraoperative- liver, pancreas and gall bladder. Small parts: breast, testes and thyroid

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Szyman
Prescription
(Signature Sign-Off)

on of Reproductive, Abdom · Padiological Devices 510(k) Number _

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic		P	P	P		P	P		See Below
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Intraoperative- liver, pancreas and gall bladder.

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

Daniel A. Symm

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K03331

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

510(k)

Diagnostic Ultrasound Indications for Use Form

UST-5539-7.5

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

Clinical Application	Modes of operation
A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial		P	P	P		P	P		See Below
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Small parts: breast, testes and thyroid

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Legum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)	P	P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		See Below
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Small parts: breast, testes and thyroid

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

Daniel A. Bergman

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

'Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number_

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial		P	P	P		P	P		See Below
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Small parts: breast, testes and thyroid

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

David G. Larson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 52 510(k) Number_

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E	E		E	E		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		E	E	E		E	E		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications- Small parts: breast, testes and thyroid

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

David A. Layman

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _

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

510(k)

Diagnostic Ultrasound Indications for Use Form UST-5712

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD Applications- Small parts: breast, testes and thyroid

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Legum

Con Sico -Offy Invision of Reproductive, Abdomin and Radiological Devices 510(k) Number_

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Intraoperative- liver, pancreas and gall bladder. Small parts: breast, testes and thyroid

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

રક

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P	P		See Below
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concu

David A. Lezama

Division Sign-Off

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033311

રક

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		E	E	E		E	E		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic					-
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

David A. Leyson
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

{41}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)	P	P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic	P	P	P	P		P	P		See Below
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Intraoperative- liver, pancreas and gall bladder.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David h. Legramm
(Division Sign-Off)

રજ

{42}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P		P	P		See Below
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

ടല

{43}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P	P		See Below
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Trausurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Anision of Reproductive, Abdomin ന്റ Radiological Devices ) 10(k; Number _______________________________________________________________________________________________________________________________________________________________

{44}------------------------------------------------

UST-9118

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P		P	P		See Below
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		P	P	P		P	P		See Below
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Daniel A. Legum

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 61 510(k) Number ________________________________________________________________________________________________________________________________________________________________

{45}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		See Below
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

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

If Sunsion Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 62 510(k) Number ________________________________________________________________________________________________________________________________________________________________

{46}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		E	E	E		E	E		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		E	E	E		E	E		See Below
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Intraoperative- liver, pancreas, gall bladder (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

63

innsion Sign-Off)

sion of Reproductive, Abdomina ାଏ Radiological Devices 5 I O(k) Number __

{47}------------------------------------------------

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

ியங்கள் Sign-Off) Sunsion of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

{48}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form UST-9126

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		E	E	E		E	E		See Below
Abdominal		E	E	E		E	E		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Abdominal and Gynecological, fetal (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 65 ා ! (^k) Number _____________________________________________________________________________________________________________________________________________________________

{49}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		E	E	E		E	E		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric		E	E	E		E	E		See Below
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David R. Lyman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

{50}------------------------------------------------

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	N	N	N	N		N	N		See Below
Transesophageal	N	N	N	N		N	N		See Below
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

{51}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		E	E	E		E	E		See Below
Adult Cephalic
Cardiac		E	E	E		E	E		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Applications: Neonatal (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abd and Radiological Devices 510(k) Number_

{52}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		E	E	E		E	E		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic		E	E	E		E	E		See Below
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Intraoperative applications: Liver, pancreas, gall bladder (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, ominal and Radiological Device 5 i O(k) Number

{53}------------------------------------------------

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		E	E	E		E	E		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		E	E	E		E	E		See Below
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD

Intraoperative applications: Liver, pancreas, gall bladder (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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.