Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac (Adult, Pediatric), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial), Intra-Operative (Neurological, Abdominal, Peripheral vascular). 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. Neonatal head 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.

Device Description

The SA8000 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 SA8000 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 SA8000 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Seventeen different models of transducers are available and any three 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. The SA8000 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. 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 BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), 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 SA8000 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.

AI/ML Overview

The Medison America, Inc. SA8000 Diagnostic Ultrasound System and its associated transducers are general purpose diagnostic ultrasound systems. The provided documentation primarily focuses on establishing substantial equivalence to previously cleared predicate devices (SA 9900 - K002185 and SA8800/HDI1500 - K974269) by demonstrating equivalent technological characteristics and intended uses.

Based on the provided information, typical "acceptance criteria" for this type of device are related to its technical specifications and intended uses being substantially equivalent to legally marketed predicate devices, as well as meeting safety standards. The study described is a submission for 510(k) clearance, which is a regulatory pathway to demonstrate substantial equivalence, rather than a clinical trial with specific performance metrics against a defined ground truth.

Here's an analysis of the provided information relative to your requested points:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for a 510(k) submission like this often revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing substantially equivalent technological characteristics and intended uses.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (SA8000)
Intended Use	The SA8000's intended uses (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal, Intra-Operative) must be substantially equivalent to those cleared for predicate devices (SA9900 - K002185 and SA8800/HDI1500 - K974269), with some new indications supported by specific transducers.	The SA8000's intended uses are listed as identical to the predicate devices (K002185 and K974269) for the majority of applications (indicated by 'P'). For certain transducers, new indications ('N') are listed (e.g., various modes of operation for Pediatric, Small Organ, Musculo-skeletal (Convent. & Superfic.), Peripheral Vessel with linear arrays; Fetal, Abdominal, Pediatric with curved array C3-7ED; Trans-rectal, Trans-vaginal with curved array EC4-9ES; Intra-operative (Abdominal, vascular), Intra-operative (Neuro.) with curved array CL4-8EV and linear array LI5-9EV; Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric with phased array P2-4AM; Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric with phased array P2-5AC; Abdominal, Pediatric, Neonatal Cephalic, Cardiac Pediatric with phased array P3-7AM). Also, new CWD indications for Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Other (spec.) for 2.0CW and 4.0CW transducers.
Technological Features	Must acquire ultrasound data and display it as B-mode, M-mode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or combinations thereof, similar to predicate devices. Must also offer ability to measure anatomical structures and provide analysis packages.	The SA8000 performs these functions, including digital beamforming technology, supporting various Linear, Convex, Phased Array and Static probes (1.0 MHz to 20.0 MHz). It offers measurement functions (distances, areas, circumferences, volumes, EDD calculations, Cardiac Analysis, Vascular Analysis), biopsy guidelines, M-mode scroll display, Cine function (up to 256 sequential images), real-time zoom, and DICOM 3.0 compatible output. This is described as operating "identical to the predicate devices."
Biocompatibility	Transducer patient contact materials must be biocompatible.	Stated that "Transducer patient contact materials are biocompatible."
Acoustic Output Limits	Must meet specified acoustic output limits (ISPTA and MI) to ensure safety.	Stated: "All Applications: ISPTA (Maximum Range 720 mW/cm2), MI 1.9. The limits are the same as predicate Track 3 devices." A post-clearance special report for acoustic output measurements based on production line devices was required.
Safety Standards	Must comply with relevant electromechanical and electrical safety standards.	The SA8000 has been designed to meet EN 60601-1 (IEC 601-1), UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, EN 60601-1-2 (IEC 60601-1-2), and is compliant with the European Medical Device Directive.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices primarily through technical specifications and intended uses, rather than a clinical performance study with a "test set" in the typical sense of AI/algorithm evaluation. Therefore, information about a specific sample size for a test set, data provenance (country of origin, retrospective/prospective), etc., is not available in this document. The "study" here is the regulatory submission itself, comparing the new device's specifications to existing ones.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
As there is no described clinical performance study with a test set requiring expert-established ground truth, this information is not applicable/not provided in the document. The regulatory review process involves FDA experts evaluating the submission against established standards and predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since there's no defined "test set" for performance evaluation, an adjudication method is not applicable/not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This submission predates the widespread use of AI in medical imaging devices and focuses on foundational ultrasound technology. No MRMC study involving AI assistance for human readers was conducted or reported in this document. This information is not applicable/not provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a diagnostic ultrasound system, which inherently requires a human operator for image acquisition and interpretation. It is not a standalone algorithm in the sense of AI. Therefore, a standalone algorithm performance study is not applicable/not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that this is a 510(k) submission for a general-purpose ultrasound system based on substantial equivalence, there isn't a "ground truth" for disease detection or diagnosis that would typically be established in a clinical trial for an AI-powered diagnostic device. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices and compliance with recognized safety standards. This information is not applicable/not provided.

8. The sample size for the training set
This document does not describe a machine learning algorithm or AI component that would typically require a "training set." Therefore, information on a training set size is not applicable/not provided.

9. How the ground truth for the training set was established
As there is no described training set, this information is not applicable/not provided.

Summary

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K013627

NOV 1 6 2001

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 - 3000 Facsimile : 714-889-3079

Email : bdepalma@medison.com

Prepared August 22, 2001

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

Proprietary Name:

SA8000 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}------------------------------------------------

3) Identification of the predicate or legally marketed device:

Medison America, Inc. believes that SA 8000 ultrasound system is substantially equivalent to the currently marketed SA 9900 ultrasound system (K002185) and SA8800/HDI1500 ultrasound system (K974269)

Device Description: 4)

Seventeen different models of transducers are available and any three 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 SA8000 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, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal, and Intra-operative. The same clinical uses were cleared for the predicate devices, SA9900 (K002185) and SA8800/HDI1500 (K974269)

{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 BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), 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 SA8000 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 SA8000 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
C22.2 No. 601.1, Canadian Standards Association, Medical Electrical . Equipment
CEVIEC 1157:1992, International Electrotechnical Commission, . Requirements for the declaration of the acoustic output of medical diagnostic 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.

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Intended Use: 5)

SA8000 intended uses as defined FDA guidance documents are:

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

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. .
. Neonatal head 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.

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

Technological Characteristics: 6)

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:

ISPTA	(Maximum Range720 mW/cm2
MI	1.9

The limits are the same as predicate Track 3 devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Medison America, Inc. % Mr. Mark Job Program Manager TÜV Product Service Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K013627

Trade Name: SonoAce SA-8000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN Product Code: 90 IYO Product Code: 90 ITX Dated: November 1, 2001 Received: November 5, 2001

Dear Mr. Job:

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 SonoAce SA-8000 Diagnostic Ultrasound System , as described in your premarket notification:

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Transducer Model Number

Image /page/6/Figure/2 description: The image shows a list of ultrasound transducers with their specifications. The list includes linear arrays such as L5-9EC, L5-9ER, HL5-9ED, L5-10ED, and LI5-9EV, along with curved arrays like C3-7ED, EC4-9ES, and CL4-8EV. Phased arrays such as P2-4AM, P2-5AC, and P3-7AM are also listed, as well as static CW transducers and volume curved arrays like S-VAW3-5, S-VAW4-7, S-VDW5-8(B), and S-VNA5-8(B).

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:

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

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (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)

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NOV 1 6 2001

Section 4.3 INDICATIONS FOR USE

K013627

DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT

510(k) No .: System:

Intended Use:

SA8000 Ultrasound System 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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic	Ophthalmic
		Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
		Abdominal	P	P	P	P1	P	Note 1	Notes 2, 7, 8
		Intra-operative (See Note 6)	P1	P1	P1		P1	Note 1	Notes 8
		Intra-operative (Neuro.)	P1	P1	P1	P1	P1	Note 1	Notes 8
Fetal Imaging& Other		Laparoscopic
		Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8
		Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 2, 8
		Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 7, 8
		Adult Cephalic	P	P	P	P	P	Note 1	Notes 8
		Trans-rectal	P	P	P		P	Note 1	Notes 2, 8
		Trans-vaginal	P	P	P		P	Note 1	Notes 2, 8
		Trans-urethral
		Trans-esoph. (non-Cardiac)
		Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 8
		Musculo-skel. (Superfic.)	P2	P2	P2		P2	Note 1	Notes 2, 8
		Intra-luminal
		Other (spec.)
		Cardiac Adult	P	P	P	P	P	Note 1	Notes 4, 7, 8
Cardiac		Cardiac Pediatric	P	P	P	P	P	Note 1	Notes 4, 7, 8
		Trans-esophageal (Cardiac)
		Other (spec.)
PeripheralVessel		Peripheral vessel	P	P	P	N	P	Note 1	Note 8
		Other (spec.)				N			Note 5

N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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, P3)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 24 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013627
Section 4.3, Page 1

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	L5-9EC / 5-9MHz / 7.5 MHz / 40mm 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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	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	Note 1	Note 2, 8
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 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 2, 8
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 8
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 8
	Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)

and Radiologi 510kl N

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, P3)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	L5-9ER / 5-9MHz / 7.5 MHz / 50mm 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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (Abdominal,vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 8
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 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 2, 8
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 8
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 8
	Other (spec.)

N= new indication; P= previously cleared by FDA in K002185 and K974269; Pl= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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, P3)

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

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K013627

Section 4.3, Page 3

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	HL5-9ED / 5-9MHz / 7.5 MHz / 40mm Linear Array
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General(Track I only)	Clinical ApplicationSpecific(Tracks I & III)	Mode of Operation (*includes simultaneous B-mode)					Combined*(Spec.)	Other(Spec.)
		B	M	PWD	CWD	Color Doppler*
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (Abdominal, vascular)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 8
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 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 2, 8
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 8
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)

PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 8
	Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)

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

	Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices	Section 4.3, Page 4
510(k) Number	K013627

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

510(k) No.: SA8000 Ultrasound System System: L5-10ED / 5-10 / 7.5 MHz / 40mm Linear Array Transducer: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation (includes simultaneous B-mode) Clinical Application Specific B M PWD CWD Color Combined Other General (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal Intra-operative (Abdominal, vascular) Intra-operative (Neuro.) Laparoscopic Fetal Imaging & Other Pediatric N N N Note 1 Note 2, 8 N Small Organ (See Note 5) N N N N Note 1 Note 2, 8 Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) N N N N Note l Note 2, 8 Musculo-skel. (Superfic.) Note 1 Note 2, 8 N N N N Intra-luminal Other (spec.) Cardiac Adult Cardiac Pediatric Cardiac Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel N N N N Note 1 Note 8 Vessel Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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, P3)

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K013627

Section 4.3, Page 5

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	LI5-9EV / 5-9MHz / 7.5 MHz / 40mm 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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (Abdominal, vascular)	N	N	N		N	Note 1	Notes 8
	Intra-operative (Neuro.)	N	N	N	N	N	Note 1	Notes 8
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
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 80

Nancy C. Hogdon

Basic Information

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

510(k) No.:System:Transducer:Intended Use:	SA8000 Ultrasound SystemC3-7ED / 3-7MHz / 4.5 MHz / 50R Curved ArrayDiagnostic 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	ColorDoppler*	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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, P3)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 80

Mancy C. bhogdm

(Division Sign-Off
Section 4.3, Page 7
Division of Reproductive, Abdominal,
and Radiological Devices
KO

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	EC4-9ES / 4-9MHz / 6.5 MHz / 10R Curved 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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	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	N	N	N		N	Note 1	Note 2, 8
	Trans-vaginal	N	N	N		N	Note 1	Note 2, 8
	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)

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

Nancy C. hogdon

(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
U
K01362

Section 4.3, Page 8

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	CL4-8EV / 4-8MHz / 6.5 MHz / 40R Curved 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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic	Ophthalmic
		Fetal ( See Note 3 )
		Abdominal
		Intra-operative (Abdominal, vascular)	N	N	N		N	Note 1	Notes 8
		Intra-operative (Neuro.)	N	N	N	N	N	Note 1	Notes 8
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.)
PeripheralVessel		Peripheral vessel
		Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)

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

Nancy C. hogdon

Section 4.3, Page 9

Division of Reproductive, Abdominal, and Radiological

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	P2-4AM / 2-4 MHz / 2.5 MHz Phased 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	N	N	N	N	N	Note 1	Note 7
	Intra-operative(Abdominal,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	Notes 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	N	N	N	N	N	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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, P3)

Concurrence of CDRH, Office of Device Evaluation (ODE)

cription Use (Per 21 CFR 801.109)
Nancy C. Borden

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

510(k) No.: System: SA8000 Ultrasound System Transducer: P2-5AC / 2-5 MHz / 3.5 MHz Phased 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 PWD M CWD Color Combined Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal N N N N N Note l Note 7 Intra-operative (Abdominal, 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 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 N N N N N Note l Note 4. 7 Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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) (PI, P2)
Note 8: 3D Imaging (P1, P2, P3)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
Nancy C. Hodgson

Sian-olancy nogam
Dancy C. Progdom
Division Sign-Off
Division of Reproductiva/ Abdominal,
nd Radiological Devices un
S

Basic Information

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	P3-7AM / 3-7MHz / 5.0 MHz Phased 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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal	N	N	N	N	N	Note 1	Note 7
	Intra-operative(Abdominal,vascular)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 7
	Small Organ (See Note 5)
	Neonatal Cephalic	N	N	N	N	N	Note 1	Note 7
	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	N	N	N	N	N	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K0136-
510(k) Number

Nancy C. Brogdon

Basic Information

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

510(k) No.:	SA8000 Ultrasound System
System:	SA8000 Ultrasound System
Transducer:	2.0CW / 2MHz / Static CW
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 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				N
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Cardiac)
		Musculo-skel. (Convent.)
		Musculo-skel. (Superfic.)
		Intra-luminal
		Other (spec.)
Cardiac		Cardiac Adult				N
		Cardiac Pediatric				N
		Trans-esophageal (Cardiac)
		Other (spec.)
PeripheralVessel		Peripheral vessel				N
		Other (spec.)				N			Note 5

N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2=previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E=added under Appendix E Additional Comments:

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)

510k)

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, P3)

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

Nancy C. Hodgson
(Division Sign-Off)
Division of Reproductive, Abdominal

Basic Information

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	4.0CW / 4MHz / Static CW
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	ColorDoppler*	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 Adult				N
Cardiac	Cardiac Pediatric				N
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				N
	Other (spec.)				N			Note 5

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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

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

510

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, P3)

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

Hilary C. hogdon

Basic Information

lite, Abdominal,
Section 4.

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	S-VAW3-5 / 3-5MHz / 3.5 MHz Volume Curved 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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic		Ophthalmic
		Fetal (See Note 3)	P2	P2	P2		P2	Note 1	Notes 2, 7, 8
		Abdominal	P2	P2	P2		P2	Note 1	Notes 2, 7, 8
		Intra-operative (Abdominal, vascular)
		Intra-operative (Neuro.)
Fetal Imaging& Other		Laparoscopic
		Pediatric	P2	P2	P2		P2	Note 1	Notes 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.)
PeripheralVessel		Peripheral vessel
		Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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, P3)

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

Nancy C. hogdon

Basic Information

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	S-VAW4-7 / 4-7MHz / 4.5 MHz Volume Curved 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)	P2	P2	P2		P2	Note 1	Notes 2, 7, 8
	Abdominal	P2	P2	P2		P2	Note 1	Notes 2, 7, 8
	Intra-operative(Abdominal,
	vascular)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P2	P2	P2		P2	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)	N	N	N		N	Note 1	Notes 2, 7, 8
	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.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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, scroturn 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, P3)

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

Nancy C. broden

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013627

Secti

Basic Information

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	S-VDW5-8(B) / 5-8MHz / 6.5 MHz Volume Curved 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(Track I 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	P2	P2	P2		P2	Note 1	Notes 2, 8
	Trans-vaginal	P2	P2	P2		P2	Note 1	Notes 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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Krogdon

Basic Information

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

510(k) No.:
System:	SA8000 Ultrasound System
Transducer:	S-VNA5-8(B) / 5-8MHz / 6.5 MHz Volume Curved 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(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	P3	P3	P3		P3	Note 1	Note 8
		Small Organ ( See Note 5 )
		Neonatal Cephalic	P3	P3	P3		P3	Note 1	Note 8
		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.)

Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)

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, P3)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K013627 Section 4.3, Page 18

Nancy C. hoodm

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.