Predicate Devices

K003739, K992663, K002784, K011457, K011315, K032875

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound device and explicitly states that it functions in the same manner as its predicates. There is no mention of AI, ML, or any related technologies in the device description or other sections.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states that the device is for "Diagnostic ultrasound imaging or fluid flow analysis," not therapeutic treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also refers to it as a "diagnostic ultrasound device".

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like a piezo-electric transducer, probe cable, and system console, which are integral to its function.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis of the human body. This involves directly interacting with the patient's body using sound waves.
Device Description: The description explains how the device transmits sound waves into the body and receives reflected waves to create images. This is a description of an in-vivo imaging device, not a device that analyzes samples taken from the body.
IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.

The device is a diagnostic ultrasound system, which is a type of medical imaging device used for in-vivo diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other. Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.

Product codes (comma separated list FDA assigned to the subject device)

90 IYN, IYO, and ITX

Device Description

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

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

Mentions image processing

The Aloka SSD-4000 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

Mentions AI, DNN, or ML

Not Found.

Input Imaging Modality

Ultrasound

Anatomical Site

Body structures for diagnosis. Specific applications listed per transducer include:
Fetal, Abdominal, Intraoperative (liver, pancreas, gall bladder), Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Indicated Patient Age Range

Not Found.

Intended User / Care Setting

Not Found.

Description of the training set, sample size, data source, and annotation protocol

Not Found.

Description of the test set, sample size, data source, and annotation protocol

Not Found.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found.

Predicate Device(s)

K003739, K992663, K002784, K011457, K011315, K032875

Reference Device(s)

K023473

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found.

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.

Summary

0

MAR 2 6 2004

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1

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

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

2

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

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

Re: K040719

Trade Name: SSD-4000 Diagnostic Ultrasound System (Version 3.1) with Optional SONOReal 3D Digital System Accessory Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: March 17, 2004 Received: March 19, 2004

Dear Mr. Reuber:

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

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

3

Transducer Model Number

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

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

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

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

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

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

4

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

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

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

Sincerely yours.

David A. Lynn

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

Enclosure(s)

5

4.3.1

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Opthalmic
Fetal		P	P	P		P	P	See Below
Abdominal		P	P	P		P	P	See Below
Intraoperative (specify)		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-skeletal
Conventional		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, B/Bflow/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801/

FR 801(09)
Daniel G. Seum

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

19

6

દરભાવ)

Diagnostic Ultrasound Indications for Use Form

ASU-67

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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)

801(09)
Omilla. byrom

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

7

UST-579T-7.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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-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 applications: liver, pancreas, and gall bladder. Small parts applications: breast, testes and thyroid.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801)

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

8

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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)

David A. bynum

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

9

Diagnostic Ultrasound Indications for Use Form

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

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P	See Below
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

Intraoperative applications: liver, pancreas and gall bladder.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 80).109

David A. Symm
(Division Sign-Off)

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

10

UST-676P-5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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)

David A. Lynn

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

11

Diagnostic Ultrasound Indications for Use Form

UST-978-3.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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)

Donald A. Jessop

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

12

Diagnostic Ultrasound Indications for Use Form

UST-979-3.5

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

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

Prescription Use (Per 21 CFR 801.109)

David A. Symms
(Division Sign-Off)

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

13

UST-984-5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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)

David A. Lynn

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

14

UST-987-7.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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)
Neonatal Cephalic		P	P	P		P	P	See Below
Adult Cephalic
Cardiac
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

Intraoperative applications: include liver, pancreas and gall bladder.

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

Prescription Use (Per 21 CFR 801.109

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

15

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

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

Janita Lynn

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

16

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P	See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P	See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P	See Below
Laparoscopic
Musculo-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 applications: liver, pancreas, and gall bladder. Small parts applications: breast, testes and thyroid.

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

Prescription Use (Per 21 CFR 80

R 891.109
David A. Lynn

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

17

ASU-1000C-3.5

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

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

David A. Syverson
Division Sign Off

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

18

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

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

David R. Syner
(Division Sign-Off)

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

19

Diagnostic Ultrasound Indications for Use Form

UST-1003

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

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

David A. Lyman
(Division Sign-Off)

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

20

Diagnostic Ultrasound Indications for Use Form

UST-2265-2

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-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)

David M. Segerson

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

21

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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-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 applications: liver, pancreas, and gall bladder. Small parts applications: breast, testes and thyroid.

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

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

22

UST-5293-5

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | | See Below | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-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)

David R. Lyman

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

23

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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 8047109)

David A. Ingram
(Division Sign-Off)

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

24

UST-5299

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

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

Daniel A. Lynam

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

25

UST-5524-5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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

Small organ applications include breast. testes and thyroid.

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

Prescription Use (Per 2148 80 109)

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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

Small organ applications include breast. testes and thyroid.

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

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

27

Diagnostic Ultrasound Indications for Use Form

UST-5526L-7.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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)
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 applications: liver, pancreas and gall bladder

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

Prescription Use (Per 21 CFR 801.109)

Daniel A. Segner

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

41

28

UST-5531

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
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

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

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

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

Daniel A. Leyman

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

29

Diagnostic Ultrasound Indications for Use Form

UST-5534T-7.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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-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 applications: liver, pancreas, and gall bladder. Small parts applications: breast, testes and thyroid.

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

Prescription Use (Per 21 CFR 801.109)

David A. Lyman

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

43

30

UST-5536-7.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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)
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 applications: liver, pancreas, and gall bladder.

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

Daniela Lyman

510(k)

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

44

31

Diagnostic Ultrasound Indications for Use Form UST-5542

OS1-3342

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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

Small Organ applications: breasts, testes and thyroid

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

Daniel h. Lyman

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

45

32

UST-5546

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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

Small parts applications: breast, testes and thyroid.

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

Daniel H. Ingram

510(k)

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

33

UST-5548

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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

Small parts applications: breast, testes and thyroid. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

David R. Syzmans

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

47

34

Diagnostic Ultrasound Indications for Use Form

UST-5710-7.5

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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-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

Small parts applications: breast, testes and thyroid.

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

Prescription Use (Per 21 CFR,

David A. Layman
(Division Sign-Off)

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

35

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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-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)

David R. Lyon

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

36

Diagnostic Ultrasound Indications for Use Form

UST-9102-3.5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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)

Danielle Lyons

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

37

Diagnostic Ultrasound Indications for Use Form UST-9103-5

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-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]

Daniel W. Lynn

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

38

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Opthalmic
Fetal
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-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 applications: liver, pancreas, and gall bladder.

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

Prescription Use (Per 21 CER

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

39

Diagnostic Ultrasound Indications for Use Form

UST-9112-5

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

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)
Opthalmic
Fetal	P	P	P	P	P	See Below
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal	P	P	P	P	P	See Below
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-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)

Daniela Lynn

(Division Sign-Off) mon of Reproductive :

40

UST-9121

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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)

David R. Gypson
(Division Sign-Off)

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

41

US1-7123

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

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

David R. Layton

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

42

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-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)

Daniel R. Lyman

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

43

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

		Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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)
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 applications: liver, pancreas, and gall bladder.

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

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

(Division Sign-Off)

Division of Reproductive, Abdomina one Radiological Devices ி

57