Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Obstetrical, Cerebrovascular, Peripheral vascular, Gynecological and fertility, Small parts, Intraoperative vascular, Abdominal surgery, Musculoskeletal (conventional), Transcranial Doppler, Pediatric general imaging, Prostate, Adult cardiology, Pediatric cardiology.

Device Description

The SA 8800/HDI 1500 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, Mmode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA 8800/HDI 1500 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 8800/HDI 1500 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Eight 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, usercustomized 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. Patient contact materials are the same as those previously cleared in the predicate device, ATL's HDI 5000 Ultrasound System and Transducers (K961459). The SA-8800/HDI 1500 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 2.0 MHz to 12.0 MHz. These probes can be applied to a variety of clinical applications such as abdominal, obstetrical, cerebrovascular, peripheral vascular, gynecological and fertility, small parts, intraoperative, vascular, abdominal surgery, conventional musculoskeletal, transcranial Doppler, pediatric general imaging, prostate, adult cardiology, pediatric cardiology. The same clinical uses were cleared for the predicate device, ATL's 5000 (K961459). The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal 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 and Vascular Analysis. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The Biopsy guides are the same as those previously cleared for the predicate device, ATL's HDI 5000 system (K961459). The operating Modes of SA-8800/HDI 1500 are B-Mode, M, Color-Flow Doppler, Continuous wave (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, or as a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor. The SA8800/HDI 1500 supports the Cine function (capable of storing up to 64 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 imagefiling function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

AI/ML Overview

The provided document is a 510(k) summary for the Medison America, Inc. SA 8800/HDI 1500 Ultrasound System, dated August 21, 1998. It details the device's characteristics and its substantial equivalence to a predicate device (ATL HDI 5000 System, K961459).

This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting an extensive study with specific acceptance criteria, sample sizes, and detailed performance metrics as would typically be found for novel AI devices or those requiring de novo classification.

Therefore, the information regarding acceptance criteria, study details, and performance metrics in the context of proving the device meets specific acceptance criteria in the way it's typically understood for new diagnostic algorithms (e.g., sensitivity, specificity, AUC values against a ground truth) is not present in this document. The device is a diagnostic ultrasound system, and its performance is established through comparison to a similar existing device.

Here's an analysis of the requested information based on the provided text:

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

There are no explicit numerical acceptance criteria (e.g., minimum sensitivity/specificity) or detailed performance metrics (like those used for novel algorithms) presented in this 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, ATL HDI 5000 System (K961459), in terms of intended use, technological characteristics, and safety standards.

The document states:

"Medison America, Inc believes that SA8800/HDI 1500 Ultrasound system is substantially equivalent to the currently marketed ATL HDI 5000 System, K961459." (Section 3)
"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 a 2D and M-mode, Continuous wave Doppler, Spectral Doppler, Color Doppler, Power Doppler, 3D images." (Section 6)
"The same clinical uses were cleared for the predicate device, ATL's 5000 (K961459)." (Section 4)
"The device's acoustic output limits are the same as predicate Track 3 devices." (Section 6)

The "performance" is considered equivalent to the predicate device, which is already legally marketed and presumed safe and effective.

No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for diagnostic capabilities are provided for the SA 8800/HDI 1500 or its predicate in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No specific test set or clinical study data (including sample sizes, data provenance, or study design) are mentioned in this 510(k) summary for establishing performance against criteria. Such detailed clinical study data is typically not required for 510(k) submissions that demonstrate substantial equivalence to a predicate device with well-established performance and intended uses.

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 no specific clinical study data is presented, there is no information about experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No information on adjudication methods for a test set is provided, as no specific clinical study data is presented.

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

No MRMC study was mentioned. The device described is a general-purpose diagnostic ultrasound system, not an AI-assisted diagnostic algorithm.

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

The device is a complete ultrasound system, not a standalone algorithm. Its performance inherently involves human operation and interpretation. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As no specific clinical study data is presented, information about the type of ground truth used is not available.

8. The sample size for the training set

No information about a training set is provided, as the submission focuses on substantial equivalence of a hardware/software system, rather than a novel algorithm development requiring a distinct training phase.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned.

Summary of Device Acceptance Approach:

The Medison America, Inc. SA 8800/HDI 1500 Ultrasound System gained market acceptance through the 510(k) Premarket Notification Pathway. This pathway relies on demonstrating substantial equivalence to a predicate device (ATL HDI 5000 System, K961459) that is already legally marketed in the US.

The "acceptance criteria" are generally met by proving that the new device:

Has the same intended use as the predicate device.
Has similar technological characteristics to the predicate device.
Raises no new questions of safety or effectiveness.

The study proving the device meets these (implicit) acceptance criteria is the substantial equivalence comparison itself, documented in the 510(k) submission. This comparison involves:

Detailed description of the new device (SA 8800/HDI 1500) including its modes of operation, available transducers, measurement capabilities, and safety standards compliance.
Identification of the predicate device (ATL HDI 5000 System, K961459).
Direct comparison of intended uses: The document explicitly states the SA 8800/HDI 1500 has the same clinical uses as the predicate, and lists them (e.g., Abdominal, Obstetrical, Cardiac, etc.). The indications for use tables (pages 6-14 of the document excerpt) show which transducers are cleared for which applications, often noting 'P' for "previously cleared in K961459" or 'N' for "new indication" (which would then require further justification not detailed in this summary).
Direct comparison of technological characteristics: The document states the device operates "identical to the predicate devices" in fundamental principles (piezoelectric material, sound wave reflection, electrical signal processing and display modes).
Comparison of acoustic output limits: The document explicitly states the device's acoustic output limits (ISPTA: 720 mW/cm2, MI: 1.9) are "the same as predicate Track 3 devices."
Biocompatibility of patient contact materials: Stated to be the same as previously cleared in the predicate device.
Electromechanical safety standards compliance: The SA 8800/HDI 1500 has been designed to meet several electromechanical safety standards (EN 60601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157, EN 60601-1-2).

The 510(k) clearance letter (pages 4-5) confirms the FDA's agreement that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing its marketing subject to general controls and a post-clearance special report on acoustic output measurements from production line devices.

Summary

{0}------------------------------------------------

SA 8800/HDI 1500 Ultrasound System

AUG 21 1998

K974269

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: 1) Medison America, Inc. 6616 Owens Drive Pleasanton, CA 94588 Bob Leiker Vice President, Regulatory and Quality Telephone: (510) 463-1830

Prepared June 24, 1998

Name of the device, including the trade or proprietary name if applicable, the common or usual 2) name, and the classification name, if known:

Common/Usual Name: Diagnostic Ultrasound System and Accessories

Proprietary Name:

SonoAce 8800 Diagnostic Ultrasound System and Transducers. Also called HDI® 1500 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

3) Identification of the predicate or legally marketed device:

Medison America, Inc believes that SA8800/HDI 1.500 Ultrasound system is substantially equivalent to the currently marketed ATL HDI 5000 System, K961459.

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

Device Description: 4)

Eight 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, usercustomized 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. Patient contact materials are the same as those previously cleared in the predicate device, ATL's HDI 5000 Ultrasound System and Transducers (K961459).

The SA-8800/HDI 1500 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 2.0 MHz to 12.0 MHz. These probes can be applied to a variety of clinical applications such as abdominal, obstetrical, cerebrovascular, peripheral vascular, gynecological and fertility, small parts, intraoperative, vascular, abdominal surgery, conventional musculoskeletal, transcranial Doppler, pediatric general imaging, prostate, adult cardiology, pediatric cardiology. The same clinical uses were cleared for the predicate device, ATL's 5000 (K961459).

The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal 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 and Vascular Analysis.

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The Biopsy guides are the same as those previously

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

cleared for the predicate device, ATL's HDI 5000 system (K961459). The operating Modes of SA-8800/HDI 1500 are B-Mode, M, Color-Flow Doppler, Continuous wave (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, or as a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor. The SA8800/HDI 1500 supports the Cine function (capable of storing up to 64 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 imagefiling function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The SA 8800/HD! 1500 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 .
CEI/IEC 1157:1992, International Electrotechnical Commission, Requirements for the declaration . of the acoustic output of medical diagnostic ultrasonic equipment
. EN 60601-1-2 (IEC 601-1-2.) European Norm, Collateral Standard: Electromagnetic compatibility
Compliant with the European Medical Device Directive Certificate issued by TUV. .

5) Intended Use:

SonoAce 8800/HDI 1500 intended uses as defined FDA guidance documents are:

. Abdominal
. Obstetrical
. Cerebrovascular
. Peripheral vascular
. Gynecological and fertility
. Small parts
. Intraoperative vascular
. Abdominal surgery
. Musculoskeletal (conventional)
. Transcranial Doppler
. Pediatric general imaging
. Prostate
. Adult cardiology
Pediatric cardiology .

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

Typical examinations performed using the system are:

General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal 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. .
Transcranial 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. .
Intraoperative application including soft tissue structures. .

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 a 2D and M-mode, Continuous wave Doppler, Spectral Doppler, Color Doppler, Power Doppler, 3D images. Scanhead 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.

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

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 21 1998

Robert Leiker Vice President Regulatory and Quality Medison America, Inc. 6616 Owens Drive Pleasanton, CA 94588

Re: K974269 Trade Name: SA8800/HDI 1500 Diagnostic Ultrasound System Regulatory Class: II/892.1550/892.1560 Product Code: 90 IYN/90 IYO Dated: July 7, 1998 Received: July 9, 1998

Dear Mr. Leiker:

We have reviewed your Section 510(k) 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 misbranion.

This determination of substantial equivalence applies to the following transducers intended for use with the SA8800/HDI 1500 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

CS-2, C7-4, C9-5ICT, L7-4, L12-5, P4-2, P7-4, D2 CW

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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

Page 2 - Robert Leiker

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

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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours.

Yin L. Aleyr
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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

510(k) Number:	K974269
Device Name:	SA 8800 System/HDI 1500 Ultrasound System

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

Mode of Operation (*includes simultaneous B-mode)

Clinical Applications	B	M*	PWD*	CWD*	ColorDoppler*	Power(Amp)Doppler*	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal (See Note 3)	N	N	N	N	N	N	Note 1	Notes 2, 4, 7,8
Abdominal	N	N	N	N	N	N	Note 1	Notes 2, 4, 7,8
Intraoperative:(See Note 6)	N	N	N	N	N	N	Note 1	Notes 2, 4, 7,8
IntraoperativeNeurological	N	N	N	N	N	N	Note 1	Notes 4, 8
Pediatric	N	N	N	N	N	N	Note 1	Notes 2, 4, 7,8
Small Organ(See Note 5)	N	N	N	N	N	N	Note 1	Notes 2, 4, 7,8
Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 4, 8
Adult Cephalic	N	N	N	N	N	N	Note 1	Notes 4, 7, 8
Cardiac	N	N	N	N	N	N	Note 1	Notes 4, 7, 8
Transesophageal
Transrectal	N	N	N	N	N	N	Note 1	Note 2, 7, 8
Transvaginal	N	N	N	N	N	N	Note 1	Note 2, 7, 8
Transurethral
Intravascular
Peripheral vascular	N	N	N	N	N	N	Note 1	Note 4, 8
Laparoscopic
Musculo-skeletalConventional	N	N	N	N	N	N	Note 1	Notes 2, 4, 8
Musculo-skeletalSuperficial
Other (Specify)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.

Note 2: Includes imaging for guidance of biopsy

Includes infertility monitoring of follicle development Note 3:
Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D Imaging
Concurrence of CDRH/Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)Prescription Use (Per 21 CFR 801.109) (x) Number

A Redological Devices TM国, InnimobdA, avitasa incomo includibed but (JJO-ugis noisivia)

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

510(k) Number:	K974269
Device Name:	SA 8800 System/HDI 1500 Ultrasound System
Transducer:	C5-2/5.0-2.0 MHz/40mm/Convex Array

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

Mode of Operation (*includes simultaneous B-mode)

Mode of Operation (*Includes simultaneous B-mode)
Clinical Applications	A	B	M*	PWD*	CWD*	ColorDoppler*	Power(Amp)Doppler*	ColorVelocityImaging	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal (See Note 3)		P	P	P		P	P		Note 1	Notes 2, 4, 7,8
Abdominal		P	P	P		P	P		Note 1	Notes 2, 4, 7,8
Intraoperative:(Specify)
Intraoperative
Neurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vascular
Laparoscopic
Musculo-skeletalConventional
Muscuio-skeletalSuperficial
Other (Specify)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Tissue Harmonic Imaging (THI) Note 7:

Note 8: 3D Imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) SE (Per 21

David C. Segner
(Division Sign-Off)

Reproductive, Abdominal, El and R:

Basic Information

Prescription Use (Per 21 CFR 801.109)

510(k) Number K974269

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

510(k) Number:	K974269
Device Name:	SA 8800 System/HDI 1500 Ultrasound System
Transducer:	C7-4/7.0-4.0 Mhz/40mm/Convex Array

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

Clinical Applications	B	M*	PWD*	ColorDoppler*	Power(Amp)Doppler*	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 4, 7,8
Abdominal	P	P	P	P	P	Note 1	Notes 2, 4, 7,8
Intraoperative:(Specify)
IntraoperativeNeurological
Pediatric	P	P	P	P	P	Note 1	Notes 2, 4, 7,8
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

Mode of Operation (*includes simultaneous B-mode)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler,

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D Imaging

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

Thimit C. Seymore
(Division Sign. Off.)

ﺪ Prescription Use (Per 21 CFR 801.109)

oductive, Abdominal, E

Basic Information

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

510(k) Number:	K974269
Device Name:	SA 8800 System/HDI 1500 Ultrasound System
Transducer:	C9-5ICT/9.0-5.0 MHz/8mm/Convex Array

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

Mode of Operation (*includes simultaneous B-mode)

Clinical Applications	B	M*	PWD*	ColorDoppler*	Power(Amp)Doppler*	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 7, 8
Abdominal
Intraoperative:(Specify)
Intraoperative
Neurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	Note 1	Notes 2, 7, 8
Transvaginal	P	P	P	P	P	Note 1	Notes 2, 7, 8
Transurethral
Intravascular
Peripheral vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Uttrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.

Note 2: Includes imaging for guidance of biopsy.

Note 3: Includes infertility monitoring of follicle development

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D Imaging

Concurrence of CDRH. Office of Device Evaluation (ODE)

David A. Watson
Division Sign-off

4 Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k)

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

510(k) Number: K974269 SonoAce 8800 System/HDI 1500 Ultrasound System Device Name: L7-4/7.0-4.0 MHz/38mm/Linear Array Transducer:

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

Mode of Operation (*includes simultaneous B-mode)

Clinical Applications	B	M*	PWD*	ColorDoppler*	Power(Amp)Doppler*	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	Note 1	Notes 2, 4, 7,8
Intraoperative:
(Specify)
Intraoperative
Neurological
Pediatric	P	P	P	P	P	Note 1	Notes 2, 4, 7,8
Small Organ	P	P	P	P	P	Note 1	Notes 2, 4, 7,
(See Note 5)							8
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vascular	P	P	P	P	P	Note 1	Notes 4, 8
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	Note 1	Notes 2, 4, 8
Musculo-skeletalSuperficial
Other (Specify)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.

Note 2: Includes imaging for guidance of biopsy

Note 4: Color M-mode

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

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D Imaging

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

Prescription Use
(Per 21 CFR 801.109)

Daniel A. Bergman
(Division Sign-Off)

Reproductive, Abdominal, El

Basic Information

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

510(k) Number:	K974269
Device Name:	SA 8800 System/HDI 1500 Ultrasound System
Transducer:	L12-5/12.0-5.0 MHz/38mm/Linear Array

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

Clinical Applications	B	M*	PWD*	ColorDoppler*	Power(Amp)Doppler*	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative:(See Note 6)	P	P	P	P	P	Note 1	Notes 2, 4, 7, 8
IntraoperativeNeurological
Pediatric	P	P	P	P	P	Note 1	Notes 2, 4, 7, 8
Small Organ(See Note 5)	P	P	P	P	P	Note 1	Notes 2, 4, 7, 8
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vascular	P	P	P	P	P	Note 1	Notes 4, 8
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	Note 1	Notes 2, 4, 8
Musculo-skeletalSuperficial
Other (Specify)

Mode of Operation (*includes simultaneous B-mode)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Uttrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.

Note 2: Includes imaging for guidance of biopsy

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel
Tissue Harmonic Imaging (THI) Note 7:

Note 8: 3D Imaging

Concurrence of CDRH, Office of Evaluation (ODF) I levice

Elvin L. Nygaard
Division Sign Off

Prescription Use (Per 21 CFR 801.109)

oductive, Abdominal

Basic Information

Number K974269

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

510(k) Number:	K974269
Device Name:	SA 8800 System/HDI 1500 Ultrasound System
Transducer:	P4-2/4.0-2.0 MHz/20mm/Phased Array

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

Mode of Operation (*includes simultaneous B-mode)

Clinical Applications	B	M*	PWD*	CWD*	ColorDoppler*	Power(Amp)Doppler*	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal (See Note 3)	P	P	P	P	P	P	Note 1	Notes 4, 7, 8
Abdominal	P	P	P	P	P	P	Note 1	Notes 4, 7, 8
Intraoperative:(Specify)
Intraoperative
Neurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 4, 7, 8
Cardiac	P	P	P	P	P	P	Note 1	Notes 4, 7, 8
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D Imaging

Concurrence of CDRH. Office of Device Evaluation (ODE)

Daniel A. Teppern
(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, and Radi

Basic Information

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

510(k) Number:	K974269
Device Name:	SA 8800 System/HDI 1500 Ultrasound System
Transducer:	P7-4/7.0-4.0 MHz/8mm/Phased Array

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

Clinical Applications	B	M*	PWD*	CWD*	ColorDoppler*	Power(Amp)Doppler*	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal (See Note 3)	P	P	P	P	P	P	Note 1	Notes 4, 7, 8
Abdominal	P	P	P	P	P	P	Note 1	Notes 4, 7, 8
Intraoperative:(Specify)
IntraoperativeNeurological	P	P	P	P	P	P	Note 1	Notes 4, 8
Pediatric	P	P	P	P	P	P	Note 1	Notes 4, 7, 8
Small Organ(Specify)
Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 4, 8
Adult Cephalic
Cardiac	P	P	P	P	P	P	Note 1	Notes 4, 7, 8
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

Mode of Operation (*includes simultaneous B-mode)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppier, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppier.

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D Imaging

Concurrence of CDRH, Office of D evice Evaluation (ODE)

David C. Seppman
(Division Sign-Off)

Reproductive, Abdor and

Surgical Devices
510(k) Number K974469

Basic Information

Prescription Use

(Per 21 CFR 801.109)

Section 4.3, Page 8

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

510(k) Number:	K974269
Device Name:	SA 8800 System/HDI 1500 Ultrasound System
Transducer:	D2 CW/2.0 MHz/Static Probe

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

Mode of Operation (*includes simultaneous B-mode)

Clinical Applications	A	B	M*	PWD*	CWD	ColorDoppler*	Power(Amp)Doppler*	ColorVelocityImaging	Combined(Specify)*	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative:(Specify)
IntraoperativeNeurological
Pediatric					P
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E

Concurrence of CDRH Device Evaluation (ODE) (Per 21 CFR 801 109) on Use

David C. Dejem
(Division Sign-Off)

Division of Reproductive, and Radiological I

510(k) Number

Basic Information

Prescription Use

(Per 21 CFR 801.109)

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.