Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging technology and image processing techniques without mentioning AI or ML.

Therapeutic

No.
The device is described as a "diagnostic ultrasound imaging or fluid flow analysis" system, and its function is to "acquire ultrasound data and to display the data" and allow for "measurement of anatomical structures and offers analysis packages that provide information that is used to make a diagnosis." There is no mention of treating or preventing a disease or condition, which would indicate a therapeutic purpose.

Diagnostic

Yes

The "Intended Use / Indications for Use" states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Furthermore, the "Device Description" section explicitly calls the SA-9900PLUS scanner a "diagnostic ultrasound system" and mentions that its analysis packages "provide information that is used to make a diagnosis by competent health care professionals."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "software controlled, diagnostic ultrasound system" and mentions the use of transducers (probes) and a system control panel, which are hardware components essential for acquiring ultrasound data.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis of the human body. This is an in vivo (within the living body) diagnostic procedure, not an in vitro (outside the living body) diagnostic procedure.
Device Description: The device description details an ultrasound system that acquires and displays ultrasound data from within the body. It measures anatomical structures and provides analysis packages based on this in vivo data.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue) outside of the body, which is the defining characteristic of an IVD.

The device is a medical imaging device used for diagnosis, but it operates by interacting with the patient's body directly, not by analyzing samples in a laboratory setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SA-9900PLUS intended uses as defined FDA guidance documents are:

Fetal (includes infertility monitoring of follicle development)
Abdominal
Pediatric
Small Organ
Adult Cephalic
Cardiac (Adult, Pediatric)
Trans-Rectal
Trans-Vaginal
Peripheral-Vascular
Muscular-Skeletal (conventional, superficial)

Typical examinations performed using the system are:

General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
Study of small parts including breasts, shoulders, thyroid, and the abdominal wall.
Pediatric scans of organs and bony structures.
Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility studies (other than in vitro fertilization).
First, second and third trimester pregnancy studies.
Prostate, prostate biopsy guidance, and rectal wall studies.
Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children.
Biopsy guidance for tissue or fluid sampling.
Conventional podiatry scans.

Diagnostic ultrasound imaging or fluid flow analysis of the human body.

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

90-IYO, 90-IYN, 90-ITX

Device Description

The SA-9900PLUS scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA-9900PLUS also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SA-9900PLUS has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Thirteen different models of transducers are available and any four may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. More detailed explanations of these functions and controls are included in Chapter 2 of the Operator manual, and in the software/firmware documentation included in this 510(k) Notification.

The SA-9900PLUS uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, organ, adult cephalic, cardiac, trans-rectal, small trans-vaginal. peripheral-vascular, and muscular-skeletal. The same clinical uses were cleared for the predicate devices, SA9900 (K002185) and SA8000 ultrasound system (K013627).

The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using GS (Gestational Sac), CRL (Crown-Rump Length), YS (Yolk Sac), BPD (Biparietal Diameter), OFD (Occipital-Frontal Diameter), HC (Head Circumference), APD (Anterior-Posterior), Abdominal Diameter, TAD (Transverse Abdominal Diameter), AC (Abdominal Circumference), FTA (Fetal Trunk Area), FL (Femur Length), TTD (Transverse Trunk/Thorax Diameter), APTD (AnteroPosterior TrunkThorax Diameter), HUM (Humerus Length), ULNA (Ulna Length), TIB (Tibia Length), RAD (Radius Length), FIB (Fibula Length), CLAV (Clavicle Length), LV (Lateral Ventricle), CEREB ( Cerebellum Diameter), OOD (Outer Ocular Distance), IOD (Inner Ocular Distance), CM (Cisterna Magna), NF (Nuchal Fold), FOOT (Foot Length), EAR (Ear Length), MP (Middle Phalenix), AFI (Amniotic Fluid Index), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio, Volume flow).

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA-9900PLUS supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (e.g. thyroid, parathyroid, breast, scrotum, penis), Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular (e.g. carotid arteries, legs, arms, feet, penile artery), Muscular-Skeletal.

Indicated Patient Age Range

Adult, Pediatric, Neonatal (for small organ applications). Fetal.

Intended User / Care Setting

Competent health care professionals. Not explicitly stated outside of this.

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K002185, K013627

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

K032329

SA-9900P

510(k) Premarket Notification

AUG - 6 2003

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

Submitter's name, address, telephone number, contact person:

Bob DePalma (714) 889-3070 Regulatory Affairs Medison America, Inc. 11075 Knott Ave. Cypress, CA 90630 Telephone : 714 - 889 - 3070 714 -- 889 -- 3079 Facsimile : Email : bdepalma@medison.com

Prepared June 14, 2002

Name of the device, including the trade or proprietary name if applicable, 2) the common or usual name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System and Accessories

Proprietary Name:

SA-9900PLUS Diagnostic Ultrasound System and Transducers.

Classification Names:	FR Number	Product Code
Ultrasound Pulsed Echo Imaging System	892.1560	90-IYO
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Diagnostic Ultrasound Transducer	892.1570	90-ITX

1

Identification of the predicate or legally marketed device: 3)

Medison America, Inc. believes that SA-9900PLUS ultrasound system is substantially equivalent to the currently marketed SA 9900 ultrasound system (K002185) and SA8000 ultrasound system (K013627).

4) Device Description:

The SA-9900PLUS scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA-9900PLUS also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SA-9900PLUS has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Thirteen different models of transducers are available and any four may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. More detailed explanations of these functions and controls are included in Chapter 2 of the Operator manual, and in the software/firmware documentation included in this 510(k) Notification.

The SA-9900PLUS uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, organ, adult cephalic, cardiac, trans-rectal, small trans-vaginal. peripheral-vascular, and muscular-skeletal. The same clinical uses were cleared for the predicate devices, SA9900 (K002185) and SA8000 ultrasound system (K013627).

2

The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using GS (Gestational Sac), CRL (Crown-Rump Length), YS (Yolk Sac), BPD (Biparietal Diameter), OFD (Occipital-Frontal Diameter), HC (Head Circumference), APD (Anterior-Posterior), Abdominal Diameter, TAD (Transverse Abdominal Diameter), AC (Abdominal Circumference), FTA (Fetal Trunk Area), FL (Femur Length), TTD (Transverse Trunk/Thorax Diameter), APTD (AnteroPosterior TrunkThorax Diameter), HUM (Humerus Length), ULNA (Ulna Length), TIB (Tibia Length), RAD (Radius Length), FIB (Fibula Length), CLAV (Clavicle Length), LV (Lateral Ventricle), CEREB ( Cerebellum Diameter), OOD (Outer Ocular Distance), IOD (Inner Ocular Distance), CM (Cisterna Magna), NF (Nuchal Fold), FOOT (Foot Length), EAR (Ear Length), MP (Middle Phalenix), AFI (Amniotic Fluid Index), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio, Volume flow).

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA-9900PLUS supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The SA-9900PLUS has been designed to meet the following electromechanical safety standards:

. EN 60601-1 (IEC 601-1,) European Norm, Medical Electrical Equipment
UL 2601-1, Underwriters Laboratories Standards, Medical Electrical . Equipment
o C22.2 No. 601.1, Canadian Standards Association, Medical Electrical Equipment
. CEI/IEC 1157:1992, International Electrotechnical Commission, Requirements for the declaration of the acoustic output of medical diagnostic

3

ultrasonic equipment

EN 60601-1-2 (IEC 60601-1-2,) European Norm, Collateral Standard: . Electromagnetic Compatibility.
Compliant with the European Medical Device Directive Certificate issued by . TUV.

Intended Use: 5)

SA-9900PLUS intended uses as defined FDA guidance documents are:

Fetal (includes infertility monitoring of follicle development) ●
Abdominal
. Pediatric
Small Organ
Adult Cephalic
Cardiac (Adult, Pediatric) .
Trans-Rectal
Trans-Vaginal
Peripheral-Vascular .
Muscular-Skeletal (conventional, superficial) ●

Typical examinations performed using the system are:

General abdominal and pelvic studies including organ surveys, . assessment, and retroperitoneal cavity studies.
Study of small parts including breasts, shoulders, thyroid, and the . abdominal wall.
Pediatric scans of organs and bony structures. ●
Peripheral vascular applications including carotid arteries, legs, arms, : feet, and penile artery.
Monitoring procedures for infertility studies (other than in vitro . fertilization).
First, second and third trimester pregnancy studies. .
Prostate, prostate biopsy guidance, and rectal wall studies. .
Trans-cranial studies of middle cerebral arteries, internal carotid artery, .

4

and vertebral arteries.

. Cardiac studies in adults and children.
Biopsy guidance for tissue or fluid sampling. .
. Conventional podiatry scans.

6) Technological Characteristics:

This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D and M-mode, Spectral Doppler, Color Doppler, Power Doppler, or 3D images. Transducer patient contact materials are biocompatible.

The device's acoustic output limits are:

All Applications:

	(Maximum Range)
ISPTA	720 mW/cm2
MI	1.9

The limits are the same as predicate Track 3 devices.

5

Image /page/5/Picture/11 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "U.S. Department of Health & Human Services USA". The eagle is depicted with three curved lines representing its wings and body, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2003

Medison America, Inc. % Ms. Laura Danielson Responsible Third Party Official 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K032329

Trade Name: SA 9900 Plus Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: July 28, 2003 Received: July 29, 2003

Dear Ms. Danielson:

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 SA 9900 Plus Diagnostic Ultrasound Systems, as described in your premarket notification:

6

Transducer Model Number

C 3-71M / 3-7 MHz / 5.0 MHz / 50R Broadband Curved Array C2-6IC / 2-6 MHz / 60R Broadhand Curved Array 1.5-121M / 5-12 MHz / 7.5 MHz / 40mm Broadband I.inear Array P2-3AC / 2-3 MHz / 2.5 MHz / Broadband Phased Array P2-5AC / 2-5 MHz / 3.5 MHz / Broadband Phased Array P2-5EC / 2-5 MHz / 3.5 MHz / Broadband Phased Array P3-7AC / 3-7 MHz / 5.0 MHz / Broadband Phased Array EC4-9IS / 4-9MHz / 6.5 MHz / 10R Broadband Curved Array S-VA W3-5 / 3-5 MHz / 3.5 MHz / Broadband Volume Curved Array S-VA W4-7 / 4-7 MHz / 4.5 MHz / Broadband Volume Curved Array S-VNW6-12 / 6-12 MHz / 8.0 MHz / Broadband Volume Linear array S-VDW5-8(B) / 5-8 MHz / 6.5 MHz / Broadband Volume Curved Array 2.0CW / 2MHz / Static CW

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This 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

7

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 80)), 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,

Nancy C. Brogdon

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

Enclosure(s)

8

Section 4.3 INDICATIONS FOR USE

DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT

510(k) No.:

System:

SA-9900PLUS Ultrasound System

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P2	P2	P2	P2	P2	Note 1	Note 2,4,5,6,7,8
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2, 5, 6, 8
	Neonatal Cephalic
	Adult Cephalic	P1	P1	P1	P1	P1	Note 1	Note 4, 7
	Trans-rectal	P	P	P	N	P	Note 1	Note 2, 3, 8
	Trans-vaginal	P	P	P	N	P	Note 1	Note 2, 3, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 6, 8
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 5, 6, 8
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P1	P1	P1	P1	P1	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	N	N	N	N	N	Note 1	Note 4,7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	Note 1	Note 5, 6
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P

Note 8: 3D Imaging (P1, P2)

Nancy C Brogdon

Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 11082329

Indication for Use

Section 4.3, Page 1

9

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801 109)

Nancy C hogdon
(Division Sign Off)

(Division Sigh Division of Reprodu and Radiological Device 510(k) Number

10

510(k) No .:

System: SA-9900PLUS Ultrasound System

C3-7IM / 3-7MHz / 5.0 MHz / 50R Broadband Curved Array Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N		N	Note 1	Note 2, 7, 8
	Abdominal	N	N	N		N	Note 1	Note 2, 7, 8
	Intra-operative (Abdominal, vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrown and penis in adult, pediatric and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

11

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off) and Radiological Devices 510(k) Number _

12

510(k) No.:

SA-9900PLUS Ultrasound System System:

C2-61C/ 2-6MHz / 60R Broadband Curved Array Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N	N	N	Note 1	Note 2, 7, 8
	Abdominal	N	N	N	N	N	Note 1	Note 2, 7, 8
	Intra-operative (Abdominal, vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; Pl= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (PI, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

13

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

Prescription Use (Per 2) CFR 801 109)

Nancy C. Brogdon

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

14

510(k) No.:

System: SA-9900PLUS Ultrasound System

LS-12IM / 5-12MHz / 7.5 MHz / 40 mm Broadband Linear Array Transducer:

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)		B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative
(Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric		N	N	N	N	N	Note 1	Note 2, 5, 6
	Small Organ (See Note 5)		N	N	N	N	N	Note 1	Note 2, 5, 6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)		N	N	N	N	N	Note 1	Note 2, 5, 6
	Musculo-skel. (Superfic.)		N	N	N	N	N	Note 1	Note 2, 5, 6
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel		N	N	N	N	N	Note 1	Note 5, 6
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (PI, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

15

;
;

Prescription Use (Per 21 CFR 801.109)

. . . . . .. .. .. .. ..

Nancyc hogdon

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

16

510(k) No.:

System: SA-9900PLUS Ultrasound System

P2-3AC / 2-3 MHz / 2.5 MHz / Broadband Phased Array Transducer:

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

	Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (Abdominal, vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	Note 1	Notes 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

17

・・・・・・・

. . . . ___ -.

Prescription Use (Per 21 CFR 801 109)

. .

.. .. ...

Nancy C. Snogdon
(Division Sign-Off)

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

Indication for Use

Section 4.3, Page 10

18

510(k) No.:

System: SA-9900PLUS Ultrasound System

P2-5AC / 2-5 MHz / 3.5 MHz / Broadband Phased Array Transducer:

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

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative
(Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P1	P1	P1	P1	P1	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	P1	P1	P1	P1	P1	Note 1	Note 4, 7
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

19

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Comments of Children

Prescription Use (Per 21 CFR 801 109)

: : : :

に、 ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Nancy hogdon

(Division Sign-Off)

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

.

20

510(k) No.:

System: SA-9900PLUS Ultrasound System

P2-5EC / 2-5MHz / 3.5 MHz / Broadband Phased Array Transducer:

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

	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	(Abdominal,
Intra-operative
vascular)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

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

21

510(k) No.:

SA-9900PLUS Ultrasound System System:

P3-7AC / 3-7MHz / 5.0 MHz /Broadband Phased Array Transducer:

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

	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	Ophthalmic
Fetal Imaging
& Other		Fetal (See Note 3)
		Abdominal
		Intra-operative (Abdominal, vascular)
		Intra-operative (Neuro.)
		Laparoscopic
		Pediatric	P2	P2	P2	P2	P2	Note 1	Note 4, 7
		Small Organ (See Note 5)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Cardiac)
		Musculo-skel. (Convent.)
		Musculo-skel. (Superfic.)
		Intra-luminal
		Other (spec.)
Cardiac		Cardiac Adult
		Cardiac Pediatric	N	N	N	N	N	Note 1	Note 4,7
		Trans-esophageal (Cardiac)
		Other (spec.)
Peripheral
Vessel		Peripheral vessel
		Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, I

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Section 4.3, Page

22

. .---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

、、、

ﻟ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤ

Prescription Use (Per 21 CFR 801.109)

Narcy C. Hodon

(Division Sign-Off)

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

23

510(k) No.:

SA-9900PLUS Ultrasound System System:

Transducer: EC4-9IS/ 4-9MHz / 6.5 MHz / 10R Broadband Curved Array

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

| Clinical Application | | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
|---------------------------|---------------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| General
(Track I only) | Specific
(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Abdominal, vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 3, 8 |
| | Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 3, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (PI)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Reprod

Radiological

k) Numbe

24

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032329

25

510(k) No.:

System: SA-9900PLUS Ultrasound System

S-VA W3-5/ 3-5 MHz / 3.5 MHz / Broadband Volume Curved Array Transducer:

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

	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative . (Abdominal, vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

26

・

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hogdon
Division Sign-Off

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

27

510(k) No .:

System: SA-9900PLUS Ultrasound System

S-VAW4-7/ 4-7 MHz / 4.5 MHz / Broadband Volume Curved Array Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks 1 & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative
(Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

28

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

、

Prescription Use (Per 21 CFR 801.109)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

、・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices V032329

510(k) Number ________________________________________________________________________________________________________________________________________________________________

29

510(k) No.:

System: SA-9900PLUS Ultrasound Svstem

Transducer: S-VNW6-12/ 6-12MHz / 8.0 MHz / Broadband Volume Linear Array /

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

	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative
(Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 8
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 8
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix F. Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Nate 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (PI, P2)

Note 4: Color M-mode (PI)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (PI, P2)

Note 8: 3D Imaging (PI, P2)

Concurrence of CDRH, Office of Device I:valuation (ODE)

30

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon
(Division Sign-Off)

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

31

510(k) No.:

System: SA-9900PLUS Ultrasound System

Transducer: S-VDW5-8(B)/ 5-8MHz/ 6.5 MHz/ Broadband Volume Curved Array

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track 1 only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (Abdominal,
vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note 1	Note 2, 8
	Trans-vaginal	P	P	P	P	P	Note 1	Note 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (PI, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2

Note 8: 3D Imaging (P1, P2)

(Division Signtoff)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K032329

ection 4.3, Page 24

32

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

SA-9900PLUS Ultrasound System System:

Transducer: 2.0CW / 2MHz / Static CW

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal-
	Intra-operative
(Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult				P1
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)

Note 2: Includes imaging for guidance of biopsy (P1, P2)

Note 3: Includes infertility monitoring of follicle development (P1, P2)

Note 4: Color M-mode (P1)

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)

Note 6: Abdominal organs and peripheral vessel (P1, P2)

Note 7: Tissue Harmonic Imaging (THI) (P1, P2)

Note 8: 3D Imaging (P1, P2)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032329

Section 4.3, Page 25

33

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

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive Ah and Radiological Devices 510(k) Number.