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, M/CD, B/CD/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.

Device Description

The Aloka SSD-3500 Ver. 7.0 diagnostic ultrasound system and transducers. High frequency sound waves are transmitted into the body by a piezoelectric 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-3500 Ver. 7.0 transducers 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 SSD-3500 Ver. 7.0 diagnostic ultrasound system and its transducers. This document confirms the device is substantially equivalent to a predicate device (Aloka SSD-3500 Ver. 1.0) and outlines its intended uses and compliance with relevant standards.

However, the document does not contain specific acceptance criteria, study data, sample sizes for test and training sets, or details about ground truth establishment, expert qualifications, or adjudication methods as typically found in a study demonstrating device performance. It is a regulatory clearance document, not a clinical study report.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance: This information is not present. The document asserts "substantial equivalence" to a predicate device, meaning its performance is considered equivalent, but no specific performance metrics or acceptance criteria for that equivalence are detailed here.
Sample sizes for the test set and data provenance: No such details are included.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such study is described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what can be extracted from the document regarding the device and its assessment:

Device: Aloka SSD-3500 Ver. 7.0 Diagnostic Ultrasound System and its associated transducers.

Nature of Assessment: Substantial equivalence (510(k) clearance) to a legally marketed predicate device, the Aloka SSD-3500 Ver. 1.0 (K023996). This means the FDA determined the new device is as safe and effective as the predicate device. The assessment primarily relies on comparing the new device's technological characteristics, indications for use, and compliance with standards to the predicate device.

Key statements of equivalence (from page 4):

"The Aloka SSD-3500 Ver. 7.0 functions in the same manner as other diagnostic ultrasound devices and its predicate."
"The Aloka SSD-3500 Ver. 7.0 and its transducers are substantially equivalent to its predicate; the Aloka SSD-3500 Ver. 1.0 and its transducers."
"The SSD-3500 Ver. 7.0 is indicated for the same diagnostic ultrasound applications to Aloka's ultrasound system: SSD-3500 Ver. 1.0 (K023996)."
"The SSD-3500 Ver. 7.0 has the same gray-scale and Doppler abilities to Aloka's ultrasound system: SSD-3500 Ver. 1.0 (K023996)."
"The SSD-3500 Ver. 7.0 uses essentially the same technologies for imaging, Doppler functions and signal processing as the following product currently marketed by Aloka: SSD-3500 Ver. 1.0 - (K023996)."
"The SSD-3500 Ver. 7.0 has the same method of use as the following products currently marketed by Aloka: SSD-3500 - (K023996)."
"The SSD-3500 acoustic power output levels are below the maximum levels allowed by the FDA."
"The SSD-3500 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka such as the: SSD-3500 -(K023996)."
"The patient contact materials used in the SSD-3500 Ver. 7.0 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-3500 Ver. 7.0 complies with electrical and physical safety standards as other products currently marketed by Aloka such as its predicate: SSD-3500 - (K023996)."
"Aloka Co., Ltd. Certifies that the SSD-3500 Ver. 7.0 complies with NEMA-UD2:2004 Rev. 3- (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment), NEMA-UD3: 2004 Rev.2- (Standard for Real Time Display of Thermal & Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment), and IEC-60601-1-2: 2001 - (Medical Electrical Equipment Part 1-2: General requirements for Safety-Collateral standard: Electromagnetic compatibility-Requirements and Tests)."

Transducers and their Indications for Use: The document lists numerous transducers and their cleared clinical applications and modes of operation (e.g., Fetal, Abdominal, Cardiac, Small Organ, Peripheral Vascular, etc., with modes like B, M, PWD, Color Doppler, Amplitude Doppler). These are presented as "previously cleared by FDA" (P) or "new indication" (N). Each indication for use form specifies which modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, Other) are cleared for various clinical applications for that specific transducer.

Study: The document does not describe a clinical study of the device's performance in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it's a regulatory submission affirming that the device is substantially equivalent to a previously cleared device based on design, intended use, technology, safety, and adherence to performance standards (NEMA-UD2, NEMA-UD3, IEC-60601-1-2). The "study" here is the comparison and certification process to meet regulatory requirements for 510(k) clearance.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a sans-serif font.

Public Health Service

FEB 16 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aloka Co., Ltd. % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K060059

Trade Name: Aloka SSD-3500 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 6, 2006 Received: January 9, 2006

Dear Mr. Lehtonen:

This letter corrects our substantially equivalent letter of January 13, 2006.

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). 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 Aloka SD-3500 Ultrasound System, as described in your premarket notification:

Image /page/0/Picture/12 description: The image shows a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, there are two lines of text that are difficult to read due to the image quality. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a dotted circle.

cling Puttic . I

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

UST-536	UST-5546
UST-672-5/7.5 (C) / (L)	UST-5548
UST-676P	UST-5710-7.5
UST-677P (L) / (T)	UST-9101-7.5
UST-978-3.5	UST-9102-3.5
UST-984-5	UST-9102(U)-3.5
UST-990-5	UST-9104-5
ASU-1003	UST-9112-5
ASU-1009	UST-9121
UST-5293-5	UST-9123
UST-5298	UST-9124
UST-5299	UST-9127
UST-5524-7.5	UST-9128
UST-5542	UST-9133

Transducer Model Number

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.

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

Page 2 - Mr. Lehtonen

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

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

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Sincerely yours,

David C. Lyunn

for

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

Enclosure(s)

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

Aloka Co., Ltd.

Model SSD-3500

K060059

510(K)

Date: 10/17/05

JAN 1 3 2006

510(k) Summary: Aloka Model SSD-3500 Ver. 7.0 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-3500 Ver. 7.0 diagnostic ultrasound system and transducers. The address is:

10 Fairfield Boulevard Wallingford, CT 06492 Tel: (203) 269-5088 Fax: 203-269-6075 The contact person is: Richard J.Cehovsky, RA/QA Coordinator

The proprietary name is the Aloka SSD-3500 Ver. 7.0 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-3500 Ver. 7.0 and its transducers are substantially equivalent to its predicate; the Aloka SSD-3500 Ver. 1.0 and its transducers.

The Aloka SSD-3500 Ver. 7.0 functions in the same manner as other diagnostic ultrasound devices and its predicate. High frequency sound waves are transmitted into the body by a piezoelectric 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-3500 Ver. 7.0 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

The Aloka SSD-3500 Ver. 7.0, 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-3500 Ver. 7.0 diagnostic ultrasound system and transducers are similar in technological characteristics to Aloka's predicate ultrasound system: SSD-3500 Ver. 1.0 (K023996).

The SSD-3500 Ver. 7.0 is indicated for the same diagnostic ultrasound applications to . Aloka's ultrasound system: SSD-3500 Ver. 1.0 (K023996).

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

510(k) Summary: Aloka Model SSD-3500 Diagnostic Ultrasound System

The SSD-3500 Ver. 7.0 has the same gray-scale and Doppler abilities to Aloka's ultrasound . system: SSD-3500 Ver. 1.0 (K023996) .
. The SSD-3500 Ver. 7.0 uses essentially the same technologies for imaging. Doppler functions and signal processing as the following product currently marketed by Aloka : SSD-3500 Ver. 1.0 - (K023996).
The SSD-3500 Ver. 7.0 has the same method of use as the following products currently . marketed by Aloka: SSD-3500 - (K023996).
The SSD-3500 acoustic power output levels are below the maximum levels allowed by the . FDA.
. The SSD-3500 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka such as the: SSD-3500 -(K023996).
The patient contact materials used in the SSD-3500 Ver. 7.0 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-3500 Ver. 7.0 complies with electrical and physical safety standards as other products currently marketed by Aloka such as its predicate: SSD-3500 - (K023996).
Aloka Co., Ltd. Certifies that the SSD-3500 Ver. 7.0 complies with NEMA-UD2:2004 Rev. . 3- (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment), NEMA-UD3: 2004 Rev.2- ( Standard for Real Time Display of Thermal & Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment), and IEC-60601-1-2: 2001 - ( Medical Electrical Equipment Part 1-2: General requirements for Safety-Collateral standard: Electromagnetic compatibility-Requirements and Tests).

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

4.3.1

Diagnostic Ultrasound Indications for Use Form SSD-3500

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-skeletal Superficial		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, M/CD, B/CD/PWD

Intraoperative 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) Shop

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

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

UST-536

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)		N	N	N		N	N		See Below
Intraoperative Neurological		N	N	N		N	N		See Below
Pediatric		N	N	N		N	N		See Below
Small Organ (specify)		N	N	N		N	N		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		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, M/CD, B/CD/PWD.

Applications: Intra-operative: liver, pancreas & gall bladder, Small parts: 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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060059

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

Diagnostic Ultrasound Indications for Use Form UST-672-517.5 (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-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, M/CD, B/CD/PWD.

Intra-operative 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 A09)

Ewind A. Jesson

(Division Sign-Off) Division of Reproductive, Abdomi 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-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, M/CD, B/CD/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. Lipton

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

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

Diagnostic Ultrasound Indications for Use Form UST-677P (L) / (T)

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)		N	N	N		N	N		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		See Below
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, M/CD, B/CD/PWD.

Intra-operative 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)

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

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

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-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, M/CD, B/CD/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 G. Ingram

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

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
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-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, M/CD, B/CD/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)

Daniela de ygomm

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices ト!(火) Number ________________________________________________________________________________________________________________________________________________________________

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

Model SSD-3500

Diagnostic Ultrasound Indications for Use Form UST-990-5

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-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, M/CD, B/CD/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 80x109)

Vaind le. Sligerm

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

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

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-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, M/CD, B/CD/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)

்

Chuision of Reproductive, Abdorgina and Radiological Devices > 1 0(k) Number ______________________________________________________________________________________________________________________________________________________________

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

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

Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		N	N	N		N	N		See Below
Abdominal		N	N	N		N	N		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-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, M/CD, B/CD/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)

Edmond Ali Seyfarth

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 100(k) Number ________________________________________________________________________________________________________________________________________________________________

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

US1-5293 -3

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-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, M/CD, B/CD/PWD.

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

Prescription Use (Per 21 CFR 801) 109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
Abdominal 159

410(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)
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, M/CD, B/CD/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.J09)

David G. Aycock
(Division Sign-Off)

Division of Reproductive. Abdominal and Radiological Devices s 10%) Number ________________________________________________________________________________________________________________________________________________________________

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		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, M/CD, B/CD/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)

Climilla. Sisson

(Division Sign-Off) Olvision of Reproductive, Abdogninati and Radiological Devices ් 19tk) Nember ______________________________________________________________________________________________________________________________________________________________

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

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	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-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, M/CD, B/CD/PWD.

Small parts application includes: 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. Andofra and Radiological Devices • ﺩﻭﺭﺍﻥ•• : : : : : : : : : : : : : : : : : : : : : : :

lim

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

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Color VelocityImaging	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-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, M/CD, B/CD/PWD.

Small parts application includes: 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)

Thinh the dyonm

(Division Sign-Off)
Division of Reproductive, Abdominal.
and Radiological Devices
510(k) Number
K160059

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

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-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, M/CD, B/CD/PWD.

Small parts application includes: 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 M. Johnson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices ි 143k) Number --------------------------------------------------------------------------------------------------------------------------------------------------------------

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

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

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

Small parts application includes: 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. Hyson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 140jk} Number ________________________________________________________________________________________________________________________________________________________________

રૂટ

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

510(k)

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:

	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
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, M/CD, B/CD/PWD.

Small parts application includes: 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 8012109)

Daniel K. Inouye

(Division Sign-Off) Division of Reproductive. Andomi red Radielogical Devines · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

ina
Kloofs

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

510(k)

Diagnostic Ultrasound Indications for Use Form 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-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, M/CD, B/CD/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 H. Lyman

(Division Sign-Off) Division of Reproductive. Abdo on Radiological Devices . . . . . . . . .

Abdominal
K0005

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

Aloka Co., Ltd.

510(k)

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:

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

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

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

Model SSD-3500

510(k)

Diagnostic Ultrasound Indications for Use Form UST-9102(U)-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
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
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, M/CD, B/CD/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. Hegeman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
Number
6005

{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)		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-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, M/CD, B/CD/PWD.

Intra-operative 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 Eyaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

L06005

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

510(k)

Diagnostic Ultrasound Indications for Use Form UST-9112-5

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-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, M/CD, B/CD/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. Segerson

"Wision Sign-Off) Susion of Reproductive, Abdomit ം Radiological Devices i (){i.) Numbe: __

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

Aloka Co., Ltd.

Model SSD-3500

. . . .

510(k)

Diagnostic Ultrasound Indications for Use Form UST-9121

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Daniel A. Seggern

(Division Sign-Off) Division of Reproductive, Abdog and Padiological Devices :

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

Aloka Co., Ltd.

510(k)

Diagnostic Ultrasound Indications for Use Form UST-9123

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-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, M/CD, B/CD/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. Leggett

(Division Sign-Off) Division of Reproductive, Abdom and Badinlogical Nevices ちゃ Astrohor

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

Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal	P	P	P	P	P	See Below
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, M/CD, B/CD/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. Lypson

Sign-Off)

Son of Reproductive, Abdominal.

Radiological Devices, 100005
Yiki Number

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

510(k)

Diagnostic Ultrasound Indications for Use Form UST-9127

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		N	N	N		N	N		See Below
Abdominal		N	N	N		N	N		See Below
Intraoperative (specify)
IntraoperativeNeurological
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, M/CD, B/CD/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. Liggon

(Division Sign-Off) Division of Reproductive, Abdo and Padiological Devices 510%) Number ...

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

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-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, M/CD, B/CD/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. Leggion

(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices , L 119k) Number _

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

Intraoperative (specify)	N	N	N	N	N	See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
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, M/CD, B/CD/PWD.

Intra-operative 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)

David A. Ayres

(Division Sign-Offi Division of Reproductive Abdom in: Radiological Devices :: 河北::××1 ;;>><

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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