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

Device Description

The Aloka SSD-4000 Ver.3.1 functions in the same manner as its predicates and other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-4000 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow. The SONOReal accessory (K023473) is an add on device.

AI/ML Overview

The provided document is a 510(k) Summary for the Aloka Model SSD-4000 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information typically found in a study proving a device meets specific acceptance criteria, and many of your requested items cannot be extracted.

Here's an analysis of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not present. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic accuracy. It asserts that the device functions in the same manner and has the same capabilities (gray-scale and Doppler) as its predicates. The safety acceptance criteria are related to acoustic power output levels and compliance with various electrical and physical safety standards.

Here's a table of the safety compliance criteria mentioned:

Acceptance Criteria	Reported Device Performance
Acoustic Power Output Levels	Below the maximum levels allowed by the FDA.
Patient Contact Material Safety Standards	Evaluated for safety via the same standards and methods as other Aloka products; found to be safe for intended uses.
Electrical and Physical Safety Standards	Complies with electrical and physical safety standards as other Aloka products.
Compliance with NEMA-UD2: 1992	Complies with NEMA-UD2: 1992.
Compliance with AIUM 1994	Complies with AIUM 1994 "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment".
Compliance with IEC-60601-1 (2001-09 Class A)	Complies with IEC-60601-1 (2001-09 Class A).
Compliance with UL 2601-1, 2nd ed. (1997)	Complies with UL 2601-1, 2nd edition (1997), Part 1, 2nd edition including Amendments 1&2.
Compliance with ISO10993-1:1997	Complies with ISO10993-1:1997.
SonoReal Accessory Standards	Met UL-2601-1, EN 60601-1-A1 & A2, and EN-60601-1-1 standards; CE marked to Directive 93/42/EEC per Annex II, Class IIa.

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

Not present. As this is a 510(k) submission based on substantial equivalence, there is no mention of a test set with patient data, sample sizes, or data provenance. The assessment relies on technical comparisons to predicate devices and adherence to regulatory standards.

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

Not present. No test set requiring ground truth established by experts is described in this document.

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

Not present. No test set or adjudication method is described.

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

Not present. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool. Therefore, no MRMC study or AI-related comparative effectiveness is mentioned.

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

Not present. This device is not an algorithm, but a hardware diagnostic ultrasound system with an optional 3D accessory. No standalone algorithm performance is discussed.

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

Not present. As there is no test set for diagnostic accuracy, no ground truth type is specified.

8. The sample size for the training set

Not present. The document does not describe a training set as it pertains to AI or machine learning. The "development and production" mentioned relate to traditional medical device manufacturing processes and quality assurance.

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

Not present. This is not applicable as no training set for an algorithm is described.

Summary

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MAR 2 6 2004

510(k) Summary: Aloka Model SSD-4000 Diagnostic Ultrasound System w/ optional SONOReal 3D system accessory.

This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.

This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-4000 Ver. 3.1 diagnostic ultrasound system and transducers w/optional SONOReal 3D system accessory. The address is:

10 Fairfield Boulevard Wallingford. CT 06492 (203) 269-5088

The contact person is: Richard J. Cehovsky, RA/QA Coordinator

The proprietary name is the Aloka SSD-4000 diagnostic ultrasound system and transducers. The common name for this type of device is a diagnostic ultrasound system and transducers.

The item in this submission is covered under the following classification:

90 IYN	Ultrasonic Pulsed Doppler Imaging System	21 CFR 892.1550
90 ITX	Diagnostic Ultrasound Transducer	21 CFR 892.1570
90 IYO	Ultrasonic Pulsed Echo Imaging System.	21 CFR 892.1560

The above as stated in 21 CFR, part 892.1570, 1560 and 1550, has been classified as regulatory Class II.

The Aloka SSD-4000 Ver. 3.1 and its transducers are substantially equivalent to its predicates; the Aloka SSD-4000 Ver.1.0 (K003739) and SSD-5500 -(K992663), (K002784), (K011457), (K011315) & (K032875) and their transducers.

The Aloka SSD-4000, like other Aloka marketed diagnostic ultrasound systems and transducers is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.

The Aloka SSD-4000 Ver.3.1 diagnostic ultrasound system and transducers are similar in technological characteristics to Aloka's initial predicate ultrasound system: SSD-4000 Ver.1.0 (K003739) as well as Aloka's SSD-5500 Ver.3.1 (K992663), SSD-5500 Ver.4.2 (K002784/ K011457), SSD-5500 Ver. 4.2.2 (K011315) and SSD-5500 Ver. 6.0 (K032875).

The SSD-4000 Ver. 3.1 is indicated for the same diagnostic ultrasound applications to Aloka's . ultrasound systems: SSD-4000 (K003739), SSD-5500- V3.1, V4.2, V4.2.2 and V6.0.
. The SSD-4000 Ver. 3.1 has the same gray-scale and Doppler abilities to Aloka's ultrasound systems as mentioned above.

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

510(k) Summary: Aloka Model SSD-4000 Diagnostic Ultrasound System w/ optional SONOReal 3D system.

The SSD-4000 Ver.3.1 uses the same technologies for imaging, Doppler functions and signal . processing as the following products currently marketed by Aloka : SSD-4000 Ver.1.0 -(K003739) and SSD-5500- V3.1, V4.2 , V4.2.2 and V6.0
The SSD-4000 Ver. 3.1 has the same method of use as the following products currently marketed . by Aloka: SSD-4000 Ver. 1.0 - (K003739) and SSD-5500-V3.1, V4.2, V4.2.2 and V6.0.
The SSD-4000 Ver. 3.1 acoustic power output levels are below the maximum levels allowed by the . FDA.
The SSD-4000 Ver. 3.1 is subjected to the same Quality Assurance systems in development and . production as other products currently marketed by Aloka such as the: SSD-4000 Ver. 1.0 -(K003739) and SSD-5500- V3.1,V4.2 ,V4.2.2 and V6.0.
The patient contact materials used in the SSD-4000 Ver. 3.1 have been evaluated for safety via the . same standards and methods as the above mentioned products marketed by Aloka. These materials have been found to be safe for the intended uses.
The SSD-4000 Ver. 3.1 complies with electrical and physical safety standards as other products ● currently marketed by Aloka such as the: SSD-4000 Ver.1.0 - (K003739) and SSD-5500- V3.1, V4.2, V4.2.2 and V6.0.
The SONOReal accessory (K023473) is an add on device that has met UL-2601-1, EN 60601-1-. A 1 & A2, and EN-60601-1-1 standards. The device is also CE marked to Directive 93/42/EEC per Annex II, as a Class IIa device.
Aloka Co., Ltd. Certifies that the SSD-4000 Ver. 3.1 complies with NEMA-UD2: 1992, AIUM . 1994 "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment", IEC-60601-1 (2001-09 Class A), UL 2601-1, 2th edition (1997), Part 1, 2nd edition including Amendments 1822 and ISO10993-1:1997. All testing was completed and the results meet the requirements of the standards above.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Aloka Co., Ltd. % Mr. Derwyn Reuber Vice President, Compliance Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K040719

Trade Name: SSD-4000 Diagnostic Ultrasound System (Version 3.1) with Optional SONOReal 3D Digital System Accessory 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: March 17, 2004 Received: March 19, 2004

Dear Mr. Reuber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the SSD-4000 Diagnostic Ultrasound System (Version 3.1) with Optional SONOReal 3D Digital System Accessory, as described in your premarket notification:

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

Transducer Model Number

ASU-67	UST-1003	UST-5546
UST-579T-7.5	UST-2265-2	UST-5548
UST-670P-5	UST-5268P-5	UST-5710-7.5
UST-672-5/7.5 (C) & (L)	UST-5293-5	UST-9101-7.5
UST-676P-5	UST-5298	UST-9102-3.5
UST-978-3.5	UST-5299	UST-9103-5
UST-979-3.5	UST-5524-5	UST-9104-5
UST-984-5	UST-5524-7.5	UST-9112-5
UST-987-7.5	UST-5526L-7.5	UST-9121
UST-990-5	UST-5531	UST-9123
UST-995-7.5	UST-5534T-7.5	UST-9124
ASU-1000C-3.5	UST-5536-7.5	UST-52109
ASU-1001	UST-5542

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

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

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

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

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

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Sincerely yours.

David A. Lynn

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

Enclosure(s)

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

4.3.1

Diagnostic Ultrasound Indications for Use Form SSD-4000 Ver.3.1

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	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/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/

FR 801(09)
Daniel G. Seum

(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 510(k) Numberg

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

દરભાવ)

Diagnostic Ultrasound Indications for Use Form

ASU-67

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-skeletalConventionalMusculo-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)

801(09)
Omilla. byrom

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

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

UST-579T-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)		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.

Intraoperative applications: liver, pancreas, and gall bladder. Small parts applications: 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)

(Pinsion 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)
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. bynum

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

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

Diagnostic Ultrasound Indications for Use Form

UST-672-5/7.5 (C) & (L)

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: 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 80).109

David A. Symm
(Division Sign-Off)

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

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

UST-676P-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		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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Lynn

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

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

Diagnostic Ultrasound Indications for Use Form

UST-978-3.5

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
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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Donald A. Jessop

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

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

Diagnostic Ultrasound Indications for Use Form

UST-979-3.5

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)

Prescription Use (Per 21 CFR 801.109)

David A. Symms
(Division Sign-Off)

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

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

UST-984-5

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
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)

David A. Lynn

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

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

UST-987-7.5

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)		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
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 Eyaluation (ODE)

Prescription Use (Per 21 CFR 801.109

{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)
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)

Janita Lynn

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

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

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)		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

Intraoperative applications: liver, pancreas, and gall bladder. Small parts applications: 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 80

R 891.109
David A. Lynn

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

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

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. Syverson
Division Sign Off

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

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

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 R. Syner
(Division Sign-Off)

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

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

Diagnostic Ultrasound Indications for Use Form

UST-1003

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
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)

David A. Lyman
(Division Sign-Off)

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

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

Diagnostic Ultrasound Indications for Use Form

UST-2265-2

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
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 M. Segerson

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

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

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

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

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

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

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

UST-5293-5

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(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-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 R. Lyman

(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		P	P	P		P	P		See Below
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal
Superficial
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 8047109)

David A. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 51 7(k) Number _______________________________________________________________________________________________________________________________________________________________

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

UST-5299

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
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. Lynam

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 5 ! O(k) Number ______________________________________________________________________________________________________________________________________________________________

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

UST-5524-5

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)		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 include 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 2148 80 109)

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

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		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 include breast. testes and thyroid.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device & valuation (ODF) Prescription Use (Per 21 CFF 8022009

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

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

Diagnostic Ultrasound Indications for Use Form

UST-5526L-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)		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 applications: 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)

Daniel A. Segner

Olvision Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 5 ! O(k) Number ______________________________________________________________________________________________________________________________________________________________

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

UST-5531

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
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. Small parts applications: 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)

Daniel A. Leyman

1 - 1 - 12 - 12 - 1996 - ADGO anu Radiological Devices 510(k) Number _

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

Diagnostic Ultrasound Indications for Use Form

UST-5534T-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)		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

Intraoperative applications: liver, pancreas, and gall bladder. Small parts applications: 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. Lyman

Owision Sign-Off) Division of Reproductive, Abdomina An Radiological Devices ം ! (K) Number ______________________________________________________________________________________________________________________________________________________________

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

UST-5536-7.5

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)		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 applications: 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)

Daniela Lyman

510(k)

3 - Sugar 1 49 ි පාලාශය of Reproductive, Abdomina san Radiniograf Devices . Hele Alamber ...............................................................................................................................................................

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

Diagnostic Ultrasound Indications for Use Form UST-5542

OS1-3342

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		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)

Daniel h. Lyman

... . . . . . . . Abdominal mingk at Devices on to [6] "Number ____________________________________________________________________________________________________________________________________________________________

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

UST-5546

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	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 parts applications: 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)

Daniel H. Ingram

510(k)

Longion Sign-Off) Onlision of Reproductive, Abdominal and Radiological Devices > 10(k) Number _______________________________________________________________________________________________________________________________________________________________

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

UST-5548

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	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 parts applications: 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 R. Syzmans

(Division Sign-Off) Division of Reproductive, Abdomina man Parliological Devices ರಿಗೆ ಮಾಡಿಗಳು ಸಾಂಪ

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

Diagnostic Ultrasound Indications for Use Form

UST-5710-7.5

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	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
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 parts applications: 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,

David A. Layman
(Division Sign-Off)

Smarri of Reproductive, Abdominal udinloqical Devices . . Milmogar ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(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)

David R. Lyon

(Division Sign-Off) Division of Reproductive, Abdomina on Redological Devices ն է Բեր ֆոլիսի

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

Diagnostic Ultrasound Indications for Use Form

UST-9102-3.5

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
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)

Danielle Lyons

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

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

Diagnostic Ultrasound Indications for Use Form UST-9103-5

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)
Ophthalmic
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]

Daniel W. Lynn

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices ra (1) | Angelses

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

Prescription Use (Per 21 CER

(Division Sign-Off)
Division of Reproductive, Abdominal
ano Rardiological Devices
K040719

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

Diagnostic Ultrasound Indications for Use Form

UST-9112-5

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

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (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)

Daniela Lynn

(Division Sign-Off) mon of Reproductive :

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

UST-9121

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
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 R. Gypson
(Division Sign-Off)

" vision of Reproductive, Abdomina ം Radiological Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

US1-7123

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	Color Doppler	Amplitude Doppler	Color Velocity Imaging	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)

David R. Layton

Off) casion of Reproductive, Abdominal the same of the county of the gray and the

{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
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) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Daniel R. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 00k) Number . ... . . . . .

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

Intended Use: Diagnostic ultrasound imaging or fluid flow anatysis 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		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 applications: liver, pancreas, and gall bladder.

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

Prescription Use (Per 21 CE 88 8 min 100 Co.

(Division Sign-Off)

Division of Reproductive, Abdomina one Radiological Devices ி

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.