The HDI 5000 system is intended for ophthalmic, fetal, abdominal, intraoperative, pediatric, small organ, adult and neonatal cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, laparoscopic, and musculoskeletal (conventional and superficial) intended uses as defined in the FDA guidance document.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal, vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.

Device Description

The HDI 5000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, M-mode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA), 3D, or in a combination of modes. The HDI 5000 system 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 HDI 5000 has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Advanced Image Processing is a feature upgrade to the HDI 5000 Ultrasound System that adds enhanced DSP image processing hardware and proprietary software algorithms to improve 2D image quality. The sub-systems affected by the software algorithms include the beamformer, signal processing, and image processing modules. The enhanced DSP hardware approximately doubles the image processing power of the HDI 5000 system, allowing processed images to be generated in real time with no loss of frame rate. The benefits of Advanced Image Processing include enhanced contrast resolution, improved tissue texture definition, clutter reduction, and better definition and continuity of tissue interfaces.

AI/ML Overview

The provided document is a 510(k) summary for the HDI® 5000 Ultrasound System with Advanced Image Processing. It focuses on the substantial equivalence to a predicate device and safety standards, rather than detailing specific acceptance criteria and a performance study in the way a clinical study report would.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.

Here's an attempt to answer based on the available information, highlighting what is missing:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for image quality improvements due to "Advanced Image Processing." Instead, it describes the benefits of the feature.

Table of Acceptance Criteria and Reported Device Performance (Based on descriptive claims, no quantitative metrics provided):

Acceptance Criterion (Implied Benefit)	Reported Device Performance (Descriptive)
Enhanced contrast resolution	Provided by enhanced DSP hardware and proprietary software algorithms.
Improved tissue texture definition	Provided by enhanced DSP hardware and proprietary software algorithms.
Clutter reduction	Provided by enhanced DSP hardware and proprietary software algorithms.
Better definition of tissue interfaces	Provided by enhanced DSP hardware and proprietary software algorithms.
Better continuity of tissue interfaces	Provided by enhanced DSP hardware and proprietary software algorithms.
Real-time image generation	Achieved with no loss of frame rate due to enhanced DSP hardware.

Acoustic Output Limits (Specific acceptance criteria, but not directly related to image quality performance of the "Advanced Image Processing" feature):

Acoustic Output Metric	Acceptance Criteria (Maximum/Range)	Reported Device Performance
All Applications Other Than Ophthalmic:
ISPTAd	720 mW/cm² (Maximum)	Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance.
TIS/TIB/TIC	0.1 - 6.0 (Range)	Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance.
Mechanical Index (MI)	1.9 (Maximum)	Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance.
ISPPAd	0 - 700 W/cm² (Range)	Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance.
Ophthalmic Applications:
ISPTAd	50 mW/cm² (Maximum)	Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance.
TIS at Surface / Thermal Index (TIC)	0.1 - 1.0 (Range)	Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance.
Mechanical Index (MI)	0.23 (Maximum)	Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance.
ISPPAd	0 - 50 W/cm² (Range)	Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance.

Study Information (Based on available text, much of this is not detailed):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document describes a feature upgrade and states "The HDI 5000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound system." The "Advanced Image Processing" feature "adds enhanced DSP image processing hardware and proprietary software algorithms to improve 2D image quality." No specific test set to evaluate this improvement is described in terms of cases or images.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. Given the nature of a 510(k) for an ultrasound system feature upgrade focusing on image quality, it's possible qualitative comparisons were made by internal experts, but this is not documented here.
- Qualifications of Experts: Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: No MRMC comparative effectiveness study is described in this document. The "Advanced Image Processing" is presented as a general improvement to image quality, not as an AI assistance tool requiring a human-in-the-loop performance evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The document describes the technical enhancements (enhanced DSP hardware and proprietary software algorithms) that improve 2D image quality. This enhancement is the "standalone" operation of the feature, as it processes the acquired ultrasound data to produce a better image. However, no quantitative standalone performance metrics (e.g., specific image quality scores, SNR improvements, contrast-to-noise ratio measurements, etc.) are provided for the "Advanced Image Processing" feature itself. The safety and effectiveness are established through substantial equivalence to a predicate device and adherence to safety standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not specified. For improvements in "contrast resolution, tissue texture definition, clutter reduction, and better definition and continuity of tissue interfaces," ground truth would typically refer to a reference standard against which image quality improvements are objectively measured. This could involve phantom studies with known properties or expert qualitative assessment of images. Neither is detailed here.
The sample size for the training set:
- Sample Size: Not specified. Given that "proprietary software algorithms" are mentioned, implying some level of algorithm development, a training set might have been used if machine learning/AI was involved. However, the document predates widespread terminology like "AI" in medical devices, and the description focuses on DSP and algorithms rather than explicit machine learning. Therefore, a "training set" in the modern sense might not have been applicable or documented as such.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not specified. See point 7 regarding the nature of the "algorithms."

Summary of what's provided for acceptance criteria and study:

The 510(k) summary focuses on establishing substantial equivalence to a predicate device (General Electric System Five) and adherence to electromechanical and acoustic output safety standards (IEC 601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, IEC 601-1-2, AIUM/NEMA 1992). The "Advanced Image Processing" feature is described in terms of its technical components (DSP hardware, software algorithms) and the perceived benefits it offers to image quality, such as "enhanced contrast resolution" and "improved tissue texture definition." However, the document does not present a formal study with quantitative acceptance criteria and detailed performance metrics specifically for the image quality improvements of this feature. The clearance implies that the FDA found the claims of effectiveness and safety to be sufficiently supported for substantial equivalence, without requiring a detailed clinical performance study report as would be expected for a novel device or AI algorithm today.

Summary

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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)

Terrence J. Sweeney Vice President, Worldwide Quality and Regulatory Affairs Advanced Technology Laboratories, Inc. P.O. Box 3003 Bothell, WA 98041-3003 (206) 487-7602

Date prepared: May 14, 1999

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

Diagnostic Ultrasound System with Accessories

Proprietary Name

HDI® 5000 Ultrasound System

Classification Names

Ultrasonic Pulsed Doppler Imaging System, Product Code 90 IYN, 21 CFR 892.1550

Diagnostic Ultrasonic Scanhead, Product Code 90 ITX, 21 CFR 892.1570

Ultrasonic Pulsed Echo Imaging System, Product Code 90IYO, 21 CFR 892.1560

3) Identification of the predicate or legally marketed device:

Advanced Technology Laboratories, Inc. believes that the Advanced Image Processing feature on the HDI 5000 system is substantially equivalent to the currently marketed General Electric System Five.

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4) Device Description:

The HDI 5000 system is designed to accept a large selection of scanheads with up to three array scanheads and one static probe being connected to the system at any one time. The operator may select among the scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.

The HDI 5000 system is designed to accept scanheads of the following types and frequency:

frequency range:	2.0 - 10.0 MHz
scanhead types:	Linear arrayCurved linear arrayPhased arrayStatic probes

Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.

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The HDI 5000 system has been designed to meet the following electromechanical safety standards:

IEC 601-1, International Electrotechnical Commission, 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
IEC 601-1-2, Collateral Standard: Electromagnetic Compatibility .

Intended Use: 5)

Typical examinations using the HDI 5000 system are:

General abdominal and pelvic studies including organ surveys, blood flow . assessment, and retroperitoneal cavity studies.
Study of small parts and superficial structures including breasts, shoulders, . thyroid/parathyroid, and the abdominal wall.
Pediatric scans of organs, superficial, 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.
Monitoring of cardiac function during procedures using transesophageal . echocardiography.
Biopsy guidance for tissue or fluid sampling.
Assessment of cardiac muscle, coronary arteries and great vessels during . cardiac surgery
. Study of myocardial function in adults
Study of eye anatomy including blood flow in retinal vessels and branches .

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Study of the esophagus, stomach, biliary sytem, pancreas and . gastrointestinal tract using endoscopic probe
Study of abdominal and pelvic organs and masses using laparoscopic probe .
Examination of organs, masses and vessels during surgical procedures .
. Study of muscles, ligaments, nerve bundles and connective tissue

Technological Characteristics: 6)

This device operates identical to the predicate device 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 Mmode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, M-mode, Color Flow, Color M-mode, Color Power Angio, and Pulsed Doppler) are the same as predicate devices identified in item 3. Scanhead patient contact materials are biocompatible.

This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1992) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.

The device's acoustic output limits are:

All Applications Other Than Ophthalmic:

ISPTAd	720 mW/cm2 (Maximum)
TIS/TIB/TIC	0.1 - 6.0 (Range)
Mechanical Index (MI)	1.9 (Maximum)
ISPPAd	0 - 700 W/cm2 (Range)
Ophthalmic Applications:
ISPTAd	50 mW/cm2 (Maximum)
TIS at Surface /Thermal Index (TIC)	0.1 - 1.0 (Range)
Mechanical Index (MI)	.23 (Maximum)
ISPPAd	0 - 50 W/cm2 (Range)

The limits are same as predicate Track 3 devices.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 1999

Terrence J. Sweeney ATL Ultrasound 22100 Bothell Everett Highway Bothell, WA 98401-3003

Re: K991671 Trade Name: HDI® 5000 Diagnostic Ultrasound System with Advanced Image Processing Regulatory Class: II Product Code: 90 IYO 21CFR 892.1560 Dated: May 14, 1999 Received: May 17, 1999

Dear Mr. Sweeney:

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 misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the HDI® 5000 Diagnostic Ultrasound System with Advanced Image Processing, as described in your premarket notification:

Transducer Model Number

L12-5/12.5-5.0 MHz/38mm/Linear Array L12-5/12.5-5.0 MHz/50mm/Linear Array

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 requlations 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 Requlation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions. 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

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Page -2- Mr. Sweeney

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 requlations.

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 requlation 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 tollfree 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 reqarding the content of this letter, please contact Paul M. Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number: K991671 System: HDI® 5000 Ultrasound System

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	P		P	P	P	P	Note 5
	Fetal	P	P	P	P	P	P
	Abdominal	P	P	P	P	P	P
	Intra-operative (Abdominal,vascular)	P	P	P	P	P	P	Notes 2, 4, 5
	Intra-operative (Neuro.)	P	P	P	P	P	P
Fetal Imaging& Other	Laparoscopic	P		P	P	P	P
	Pediatric	P	P	P	P	P	P	Notes 2, 4, 5
	Small Organ (breast, thyroid,testicles)	P	P	P	P	P	P	Notes 2, 4, 5
	Neonatal Cephalic	P	P	P	P	P	P
	Adult Cephalic	P	P	P	P	P	P
	Trans-rectal	P	P	P	P	P	P
	Trans-vaginal	P	P	P	P	P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P	P	P	P	Notes 2, 4, 5
	Musculo-skel. (Superfic.)	P	P	P	P	P	P	Notes 2, 4, 5
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P
	Trans-esophageal (card.)	P	P	P	P	P	P
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	Notes 4, 5
	Other (spec.)

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

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Color Doppler includes Color Amplitude Doppler

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

Note 2: Includes imaging for guidance of biopsy

Note 3: For example: thyroid, parathyroid, breast, scrotum and penis in adult pediatric and neonatal patients.

Note 4: Color M-mode

Note 5: Advanced Image Processing

Prescription Use (Per 21 CFR 801.109)

Jaind A. Segram

n Sign-Off) f Reproductive, Abdominal, El

510(k) Number K991671

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:	K991671
System:	HDI 5000 Ultrasound System
Scanhead:	L12-5/12.5-5.0 MHz/38mm/Linear Array

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic	P	P	P		P	Note 1	Note 5
	Fetal
	Abdominal
	Intra-operative (Abdominal,vascular)	P	P	P		P	Note 1	Notes 2, 4, 5
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 4, 5
	Small OrganSee Note 3	P	P	P		P	Note 1	Notes 2, 4, 5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 4, 5
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 4, 5
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Notes 4, 5
	Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Color Doppler includes Color Amplitude Doppler

Note 1: PWD/Color Dop., PWD/Power Doppler (previously cleared)

Note 2: Includes imaging for guidance of biopsy (previously cleared)

Note 3: For example: thyroid, parathyroid, breast, scrotum and penis in adult pediatric and neonatal patients.

Note 4: Color M-mode (previously cleared)

Note 5: Advanced Image Processing

Prescription Use (Per 21 CFR 801.109)

Daniel A. Graham

Sign-Off Division of Reproductive, Abdominal, and Radiological

510(k) Number K991671

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:	K991671
System:	HDI® 5000 Ultrasound System
Scanhead:	L12-5/12.5-5.0 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	E	E	E		E	Note 1	Note 5
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Abdominal,vascular)	E	E	E		E	Note 1	Notes 2, 4, 5
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	E	E	E		E	Note 1	Notes 2, 4, 5
	Small OrganSee Note 3	E	E	E		E	Note 1	Notes 2, 4, 5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	E	E	E		E	Note 1	Notes 2, 4, 5
	Musculo-skel. (Superfic.)	E	E	E		E	Note 1	Notes 2, 4, 5
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	E	E	E		E	Note 1	Notes 4, 5
	Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Color Doppler includes Color Amplitude Doppler

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

Note 2: Includes imaging for guidance of biopsy

Note 3: For example: thyroid, parathyroid, breast, scrotum and penis in adult pediatric and neonatal patients.

Note 4: Color M-mode

Note 5: Advanced Image Processing

Prescription Use (Per 21 CFR 801.109)

David A. Nyman

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De

510(k) Number K991671

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.