ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM by ALOKA CO. LTD USA

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (specify), Intraoperative Neurological, Pediatric, Small Organ (specify), 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. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast, testes and thyroid.

Device Description

The Aloka SSD-5500 V6.0 functions in the same manner as 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-5500 V6.0 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

AI/ML Overview

The provided text is a 510(k) summary for the Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study performance metrics or acceptance criteria for a novel AI algorithm. Therefore, much of the requested information regarding acceptance criteria and performance against those criteria, as well as specific details about test and training sets, expert qualifications, and comparative effectiveness studies, is not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the listed predicate devices across various clinical applications and operation modes.

Acceptance Criteria Category	Reported Device Performance	Comments
Technological Characteristics	- Uses essentially the same technologies for imaging, Doppler functions, and signal processing as predicate devices (SSD-1700, SSD-5500 V3.1, V4.2, V4.2.2).	This indicates that its fundamental operation and expected performance are on par with established devices.
Method of Use	- Has the same method of use as predicate devices.	Ensures similar user interaction and clinical workflow.
Acoustic Power Output Levels	- Below the maximum levels allowed by the FDA.	Complies with safety regulations.
Quality Assurance	- Subjected to the same Quality Assurance systems in development and production as predicate devices.	Implies adherence to established manufacturing and testing standards for reliability and safety.
Patient Contact Materials	- Evaluated for safety via the same standards and methods as predicate devices; found safe for intended uses.	Focuses on biocompatibility and safety for patient contact.
Electrical and Physical Safety Standards	- Complies with electrical and physical safety standards (NEMA-UD2: 1992, AIUM 1994, IEC-60601-1, UL 2601-1, ISO10993-1). All testing completed and results meet requirements.	Demonstrates adherence to recognized international safety and performance standards.
Indications for Use (with Transducers)	The device, with its various transducers, supports a wide range of clinical applications including: Fetal, Abdominal, Intraoperative (liver, pancreas, gall bladder), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal (Conventional & Superficial). For most applications, the device's capability (B, M, PWD, Color Doppler, Amplitude Doppler) is marked as "P" (previously cleared by FDA) or "E" (added under Appendix E), indicating equivalence to or extension of existing cleared indications.	This is the primary "performance" stated, demonstrating its clinical utility across various body regions and diagnostic modes, consistent with predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a sample size for a test set or the provenance (country of origin, retrospective/prospective) of any specific data used to evaluate the substantial equivalence from a performance perspective.
The evaluation appears to be based on a comparison to characteristics and performance of existing legally marketed predicate devices, rather than a new clinical study with a distinct test set for performance metrics. The tables listing "P" (previously cleared by FDA) and "E" (added under Appendix E) suggest that the current device is being compared to the established performance of the predicate device for those indications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document.
Given that this is a 510(k) submission asserting substantial equivalence to predicate devices, it's unlikely that new "ground truth" establishment by a panel of experts for a novel device performance study was required or conducted in the manner of a de novo submission. The "ground truth" for the predicate devices' performance would have been established during their initial clearances.

4. Adjudication Method:

This information is not provided in the document.

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:

This information is not applicable and therefore not provided. The Aloka SSD-5500 V6.0 is a diagnostic ultrasound system, not an AI-powered image analysis or diagnostic aid designed to be used in conjunction with human readers to improve their performance. It's a standalone imaging device.

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

The device being evaluated is a standalone diagnostic ultrasound system. Its performance is inherently "standalone" in the sense that it generates images and Doppler information directly. However, it is not an "algorithm only" device; it's a complete hardware and software system for image acquisition and display. The clinical performance is tied to the images and data it produces, which are then interpreted by a human operator/physician.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the purpose of this 510(k) submission, the "ground truth" for the new device's performance is established by demonstrating its substantial equivalence to the performance and characteristics of its predicate devices. The predicate devices themselves would have had their performance (and hence their implicitly "ground-truth-validated" capabilities) established through various means at the time of their clearance, which could have included expert consensus, physical phantom testing, and clinical evaluations. The document does not specify how the predicate devices' performance was originally validated, only that the new device meets those established standards.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. This device is a traditional diagnostic ultrasound system, not an AI/ML-driven device that requires a "training set" of data in the sense typically associated with machine learning algorithms.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable and therefore not provided, as the device doesn't rely on a "training set" in the AI/ML context.

In summary:

This 510(k) submission for the Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System primarily demonstrates its substantial equivalence to previously cleared predicate devices by comparing their technological characteristics, methods of use, safety, and indications. It does not contain details about specific clinical studies with distinct acceptance criteria, test/training sets, or expert ground truth establishment as would be expected for a novel AI/ML device. The "proof" the device meets acceptance criteria is fundamentally its demonstrated sameness in key aspects to already cleared devices and adherence to relevant safety standards.

Summary

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Aloka Co., Ltd.

510(k)

SEP 3 0 2003

510(k) Summary: Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System

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-5500 V6.0 diagnostic ultrasound system and transducers. The address is:

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

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

The proprietary name is the Aloka SSD-5500 V6.0 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-5500 V6.0 and its transducers are substantially equivalent to its predicates; the Aloka SSD-1700 and SSD-5500 Versions 3.1, 4.2 and 4.2.2 and its transducers.

The Aloka SSD-5500 V6.0, like other Aloka marketed diagnostic ultrasound systems and transducers are indicated for imaging body structures to aid in the diagnosis of disease or abnormality.

The Aloka SSD-5500 V6.0 diagnostic ultrasound system and transducers are similar in technological characteristics to Aloka's initial predicate ultrasound system: SSD-1700 (K963616) as well as Aloka's SSD-5500 Ver.3.1 (K992663), SSD-5500 Ver.4.2 (K002784/ K011457) and SSD-5500 Ver. 4.2.2 (K011315).

The SSD-5500 V6.0 is indicated for the same diagnostic ultrasound applications to Aloka's . ultrasound systems: SSD-1700 (K963616), SSD-5500- V3.1, V4.2 , V4.2.2.
The SSD-5500 V6.0 has the same gray-scale and Doppler abilities to Aloka's ultrasound systems . as mentioned above.

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510(k) Summary: Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System

. The SSD-5500 V6.0 uses essentially the same technologies for imaging, Doppler functions and signal processing as the following products currently marketed by Aloka : SSD-1700 - (K963616) and SSD-5500- V3.1, V4.2 and V4.2.2 .
. The SSD-5500 V6.0 has the same method of use as the following products currently marketed by Aloka: SSD-1700 - (K963616) and SSD-5500-V3.1, V4.2 . & V4.2.2.
. The SSD-5500 V6.0 acoustic power output levels are below the maximum levels allowed by the FDA.
. The SSD-5500 V6.0 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka such as the: SSD-1700 -{K963616} and SSD-5500- V3.1,V4.2, & V4.2.2.
. The patient contact materials used in the SSD-5500 V6.0 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-5500 V6.0 complies with electrical and physical safety standards as other products . currently marketed by Aloka such as the: SSD-1700 - (K963616) and SSD-5500- V3.1, & V4.2. V4.2.2.
Aloka Co., Ltd. Certifies that the SSD-5500 V6.0 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, 2th edition including Amendments 1&2 and ISO10993-1:1997. All testing has been completed and the results meet the requirements of the standards above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.

Public Health Service

SEP 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K032875

Trade/Device Name: Aloka SSD-5500 V6.0 Diagnostic Ultrasound System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulatory Class: II Dated: September 11, 2003 Received: September 15, 2003

Dear Mr. Sherratt:

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 Diagnostic Ultrasound System, Model SSD-5500 V 6.0, as described in your premarket notification:

Transducer Model Number

ASU-67-10/7.5	UC140P-AL5	UCT140-AL-5	UST-533
UST-547	UST-672-5/7.5	UST-675P	UST-995-7.5
UST-987-7.5	ASU-1000C-3.5	ASU-1001	ASU-1002
ASU-1005	UST-2265-2	UST-5268P-5	UST-5271S-5

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Page 2 - Mr. Donald Sherratt

UST-5276-5	UST-5280-5	UST-5281-5	UST-5286-2.5
UST-5287-3.5	UST-5293-5	UST-5294-5	UST-5296
UST-5524-5	UST-5524-7.5	UST-5526L-7.5	UST-5531
UST-5534T-7.5	UST-5536-7.5	UST-5539-7.5	UST-5543
UST-5545	UST-5548	UST-5712	UST-5713T
UST-9101-7.5	UST-9102-3.5	UST-9104-5	UST-9114-3.5
UST-9115-5	UST-9118	UST-9119	UST-9120
UST-9121	UST-9126	UST-9128	UST-52101
UST-52104	UST-52108	UST-52109	UST-MC11-8731

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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Page 3 – Mr. Donald Sherratt

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

Sincerely yours,

Nancy C. Brogdon
Nancy C. Brogdon

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

Enclosures

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4.3.1

Diagnostic Ultrasound Indications for Use Form

SSD-5500 V6.0

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

Prescription Use (Per 21 CFR 801.109)

FR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032875

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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)

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

Nancy C. brogdon

(Division Sign-Off) Division of Reproduc and Radiological Devic 510(k) Number

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

Prescription Use (Per 21 CFR 801 109

Nancy C. brogdon

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

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

UCT140-AL-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) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. brogdon
(Division Sign-Off)

Division of Reprodu ctive. Andal and Radiological Device 510(k) Number

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

UST-533

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. brogdon

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

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

UST-547

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

Prescription Use (Per 21 CFR 801.109)

Device Evaluation (ODE)
CFR 801.109 Nancy C. Brogdon
(Division Sign-Offl

Division of Reproductiv and Radiological Devi 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form UST-672-517.5

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		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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

FR 801.109ancy C. hogdon
(Division Sign-Off)

Division of Reproductive. A and Radiological Device 510(k) Number .

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

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)
Ophthalmic
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)

Nancy C. Brogdon

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

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

UST-995-7.5

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.

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

Prescription Use (Per 21 CFR 801

01/09)
Nancy C. brogdon

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

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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)
Ophthalmic
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 Evaluation (ODE) Prescription Use (Per 21 CFR 801.10) Jan C

CFR 801.10 Jancy C. Brogdom
(Division Sign-Off)
Division of Reproductive Abdominal

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

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

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

Nancy Chroydon

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

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

ASU-1001

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 801.1

801.109)
Nancy C. hogdon

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

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

ASU-1002

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)

Nancy C. Hogdon

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

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

ASU-1005

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.

1 CFR 801.109)

Nancy C. hogdon

(Division Sign-Off)

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

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

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				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 801.10)

vice Evaluation (ODE)
CFR 801.10ancy C. hogdon
(Division Sign-Off)

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

UST-5268P-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		P	P	P		P	P		See Below
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		P	P	P		P	P		See Below
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) Prescription Use (Per 21 CFR 801.1QS

cy C. hogdon

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

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

UST-5271S-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		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-skeletal
Conventional
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 801.109)

Nancy C. Shogdon
(Division Sign-Off)

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

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

UST-5276-5

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
Intraoperative (specify)
Intraoperative Neurological
Pediatric		E	E	E		E	E		See Below
Small Organ (specify)
Neonatal Cephalic
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

(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)

Nancy C. hogdon

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

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

UST-5280-5

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		P	P	P		P	P		See Below
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

(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)

Nancy C. bogdon
(Division Sign-Off)

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

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

UST-5281-5

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		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
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

Nancy C. brogdon

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

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

UST-5286-2.5

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	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)

Nancy C. hogdon

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

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

UST-5287-3.5

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
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
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

(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)

Nancy C. hogdon

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 41510(k) Number_

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

UST-5293-5

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		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)

Nancy C. brogdon

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

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	P		See Below
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

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 801.10

01.109) Nancy C. hogdon

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

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

UST-5296

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

Nancy C. hogdon

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

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

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: 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)

Nancy C. hogdon

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

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

UST-5524-7.5

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)		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

Nancy C. brogdon

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

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

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-skeletal Conventional
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

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

CFR 801.109
Nancy C. hogdon
(Division Sign-Off)

Division of Reproductive, A and Radiological Device 510(k) Number _

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

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	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 801.105

CFR 801.109Nancy C. hogdon
(Division Sign-Off)

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

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

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	Color Velocity Imaging	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

Nancy C. brogdon

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

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

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

Prescription Use (Per 21 CFR 801.109

Nancy C. hogdon

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

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

UST-5539-7.5

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)		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

TR 801.109
Nancy C. brogdon
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032875

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

UST-5543

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		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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.18

CFR 801.109
Nancy C. hogdon
(Division Sign-Off)

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

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

UST-5545

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 11032825

510(k) Number _

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

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. hogdon

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

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

UST-5712

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)		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 80)

CFR 801.109)
Nancy C. hogdon
(Division Sign-Off)

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

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

UST-5713T

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)

Nancy C. hogdon
(Division Sign-Off)

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

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

UST-9101-7.5

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		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)

Nancy C. hogdon

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

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

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		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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

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

UST-9104-5

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
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

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)

Nancy C. brogdon

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

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

UST-9114-3.5

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

Nancy C. brogdon

(Division Sign-Off) Division of Reproduc and Radiological D 510(k) Number

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

UST-9115-5

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)

Nancy C. hogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 03 510(k) Number _

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

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hogdon

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

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

UST-9119

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)

Nancy C. Hogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 63 510(k) Number _

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

UST-9120

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 801.10)

Nancy C. Brogdon

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

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

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

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

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

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)

Nancy C. hogdon

(Division Sign-Off Division of Reproductive, Abdomina 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		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)

Nancy C. brogdon

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

UST-52101

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		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

(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)

Nancy C. hogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices S10(k) Number ________________________________________________________________________________________________________________________________________________________________

{54}------------------------------------------------

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		N	N	N		N	N		See Below
Transesophageal		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)

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

Nancy C. hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 2032875

{55}------------------------------------------------

UST-52108

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		E	E	E		E	E		See Below
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

Nancy C. hogdon
(Division Sign-Off)

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

{56}------------------------------------------------

UST-52109

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)
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)

Nancy C. hogdon

{57}------------------------------------------------

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

CFR 801.109

Nancy C. hogdm

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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.