The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of 3-D Imaging will not add new indications for use to the Elegra. It will allow the user to display regions of interest in 3-dimensional format, either by showing views in three orthagonal planes or allowing surface rendering of objects.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (followed by tables listing specific applications and modes of operation for different transducers)

Device Description

The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

AI/ML Overview

This document is a 510(k) summary for the Addition of 3D Imaging to the SONOLINE Elegra Diagnostic Ultrasound system. It outlines the device's description, intended uses, and technological comparison to a predicate device, but it does not contain details about a clinical study with acceptance criteria and device performance.

The tables provided in the document list various clinical applications for different transducers (e.g., SONOLINE Elegra, 2.0 CW probe, 2.5PL20 Phased Array Transducer, etc.) and indicate whether each application is a "new indication" (N), "previously cleared by FDA" (P), or "added under Appendix E" (E) for certain imaging modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, Other). This information relates to the intended uses and regulatory clearance rather than a performance study.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's a breakdown of the specific points you requested and why they cannot be extracted from this document:

A table of acceptance criteria and the reported device performance: This document does not contain any such table or details of a performance study with acceptance criteria. It primarily focuses on regulatory clearance and intended uses.
Sample size used for the test set and the data provenance: Not available. The document does not describe a test set or its provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. Ground truth establishment for a test set is not discussed.
Adjudication method for the test set: Not available. There is no mention of a test set or adjudication.
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: Not available. This document predates common AI applications in medical imaging and does not discuss such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. No details on algorithm performance are provided.
The type of ground truth used: Not available. The document does not discuss ground truth for performance evaluation.
The sample size for the training set: Not available. Training sets are not mentioned.
How the ground truth for the training set was established: Not available. Ground truth for a training set is not discussed.

This 510(k) summary is a regulatory filing focused on demonstrating substantial equivalence to previously cleared devices for new features (3D imaging) and expanded use of existing transducers, rather than a clinical performance study report.

Summary

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MAY 2 7 1998 510(K) SUMMARY

Addition of 3 D Imaging to SONOLINE Elegra Diagnostic Ultrasound system

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

Submitted By: 1.

Siemens Medical Systems, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98027-7002

Contact Person: Steve Hesler Manager of Regulatory Affairs (425) 557-1629

Date Prepared: March 31, 1998

1. Proprietary Name: SONOLINE Elegra Advanced SONOLINE Elegra
  Common/ Usual Name: Diagnostic Ultrasound System with Accessories

Classification Name: Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 892.1550)

3. Predicate Device:

K945072, 11/21/95, cleared as the Q4000, marketed as the SONOLINE Elegra Advanced

K950517, 4/5/96, cleared as Q64XX, marketed as the SONOLINE Elegra K961833, 10/29/96, SieScape panoramic display for SONOLINE Elegra Advanced

4. Device Description:

The SONOLINE ® Elegra, has been designed to meet the following product safety standards:

UL 2601, Safety Requirements for Medical Equipment .
CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment .
Standard for Real Time Display of Themal and Mechanical Indices on . Diagnostic Ultrasound Equipment, AlUM/NEMA, 1992.
93/42/EEC Medical Devices Directive

EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment

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5. Intended Uses:

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Technological Comparison to Predicate Device: 6.

SONOLINE Elegra is a previously cleared device. The purpose of this submission is to receive clearance for the addition of 3 dimensional imaging to the already-cleared svstem. This real-time reconstruction technique is equivalent to the SieScape panaoramic imaging feature already cleared by 510(k) (see K961833, 10/29/96).

End of 510(k) Summary

t with 5

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a row.

MAY 2 7 1998

Siemens Medical Systems. Inc. Ultrasound Group c/o Joseph P. Murnane Underwriters Laboratories, Inc. 1285 Walt Whitman Road Melville, New York 11747-3081 Rc:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K981626 Sonoline® Elegra Diagnostic Ultrasound System Dated: May 1, 1998 Received: May 7, 1998 Regulatory class: II Procodes: 90 IYN, 21 CFR 892.1550 90 IYO, 21 CFR 892.1560 90 ITX, 21 CFR 892. 1570

Dear Mr. Murnane:

We have reviewed your Section 510%) 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 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 Festeral 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 agginst misbranding and adulteration.

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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devise in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electrotic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) 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 the 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) 594-4613. 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".

Sincerely yours,

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510 (k) Number (if

known) :

SONOLINE Elegra with SieScape and 3 D Imaging Device Name :

Intended Use:

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

Mode of Operation

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	BMDC (P)
Abdominal	P	P	P	P	P	P	BMDC (P)
Intraoperative(Specify)	P	P	P	P	P	P	BMDC (P)
Pediatric	P	P	P	P	P	P	BMDC (P)
Small Organ(Specify)	P	P	P	P	P	P	BMDC (P)
Neonatal Cephalic	P	P	P	P	P	P	BMDC (P)
Adult Cephalic	P	P	P	P	P	P	BMDC (P)
Cardiac	P	P	P	P	P	P	BMDC (P)
Transesophageal
Transrectal	P	P	P	P	P	P	BMDC (P)
Transvaginal	P	P	P	P	P	P	BMDC (P)
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	BMDC (P)
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	BMDC (P)
Musculo-skeletalSuperficial
Other (specify)

N = new indication;

P = previously cleared by FDA;

E = added

under Appendix E

Additional Comments:

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

Prescription Use (Per 21 CFR 801.109)

David G. Seymore
(Division Sign-Off)

(Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981626

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510 (k) Number (if

known) :

2.0 CW probe Device Name :

Intended Use:

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

Mode of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Specify)					P
Pediatric					P
Small Organ(Specify)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Transesophageal
Transrectal					P
Transvaginal					P
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal					P
Conventional
Musculo-skeletalSuperficial
Other (specify)

under Appendix E

Additional Comments:___

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

David C. Severson
(Division Sign-Off)

(Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K481626

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

510 (k) Number (if

known) :

2.5PL20 Phased Array Transducer Device Name :

Intended Use:

2.5F E20 Friased Aray andy or fluid flow analysis of the human body as follows:

Mode of Operation

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	E	E	E	E		E		BMDC (E)
Abdominal	E	E	E	E		E		BMDC (E)
Intraoperative(Specify)
Pediatric	E	E	E	E	E	E		BMDC (E)
Small Organ(Specify)
Neonatal Cephalic	E	E	E	E	E	E		BMDC (E)
Adult Cephalic	E	E	E	E	E	E		BMDC (E)
Cardiac	E	E	E	E	E	E		BMDC (E)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	E	E	E	E	E		E		BMDC (E)
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)
N = new indication; P = previously cleared by FDA; E = addedunder Appendix EAdditional Comments:

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

Prescription Use (Per 21 CFR 801.109)

David A. Segerson
Division Sign Off

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

510(k) Number _ K981626

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

510 (k) Number (if

known) :

3.5PL28 Phased Array Transducer Device Name :

Intended Use:

5.5F E20 Thused Airay Truid flow analysis of the human body as follows:

Mode of Operation

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Ophthalmic			P	P	P	P	BMDC (P)
Fetal	P	P	P	P	P	P	BMDC (P)
Abdominal	P	P	P	P		P	BMDC (P)
Intraoperative(Specify)
Pediatric	P	P	P	P	P	P	BMDC (P)
Small Organ(Specify)
Neonatal Cephalic	P	P	P	P	P	P	BMDC (P)
Adult Cephalic	P	P	P	P	P	P	BMDC (P)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	BMDC (P)
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)
N = new indication; P = previously cleared by FDA; E = added
under Appendix E
Additional Comments:

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

Prescription Use (Per 21 CFR 801.109)

Jarid a. Jesson

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

981626 510(k) Number

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510 (k) Number (if

known) :

3.5C40 Curved Array Transducer Device Name :

Intended Use:

3.5040 Cul ved Array Transade of the data visis of the human body as follows:

Mode of Operation

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (Specify)
Ophthalmic
Fetal	E	E	E	E	E	BMDC (E)
Abdominal	E	E	E	E	E	BMDC (E)
Intraoperative (Specify)
Pediatric	E	E	E	E	E	BMDC (E)
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	E	E	E	E	E	BMDC (E)
Laparoscopic	E	E	E	E	E	BMDC (E)
Musculo-skeletal Conventional	E	E	E	E	E
Musculo-skeletal Superficial
Other (specify)
N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:

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

David A. Lyons

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K487422

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

510 (k) Number (if known) : Device Name :

5.0HDPL40 Linear Array Transducer

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

Mode of Operation

ClinicalApplication	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	BMDC (P)
Abdominal	P	P	P	P	P	BMDC (P)
Intraoperative(Specify)
Pediatric	P	P	P	P	P	BMDC (P)
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	BMDC (P)
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	BMDC (P)
Musculo-skeletalSuperficial
Other (specify)

N = new indication;

P = previously cleared by FDA;

E = added

under Appendix E

Additional Comments:

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

David G. Bergman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981626

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

510 (k) Number (if known) :

5.0C50 Curved Array Transducer Device Name :

Intended Use:

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

Mode of Operation

ClinicalApplication	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	BMDC (P)
Abdominal	P	P	P	P	P	BMDC (P)
Intraoperative(Specify)
Pediatric	P	P	P	P	P	BMDC (P)
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	BMDC (P)
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	BMDC (P)
Musculo-skeletalSuperficial
Other (specify)
N = new indication: P = previously cleared by FDA: E = added

under Appendix E

Additional Comments:

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

David A. Hanson

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

510(k) Number K981626

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

510 (k) Number (if

known) :

6.5EC10 Curved Array Transducer Device Name :

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

Mode of Operation

ClinicalApplication	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Specify)
Pediatric
Small Organ(Specify)	E	E	E	E	E	BMDC (E)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	E	E	E	E	E	BMDC (E)
Transvaginal	E	E	E	E	E	BMDC (E)
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)
N = new indication; P = previously cleared by FDA; E = addedunder Appendix F

Additional Comments:

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

David A. Seigman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981626

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

510 (k) Number (if

known) :

6.5EV13 Curved Array Transducer Device Name :

Intended Use:

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

Mode of Operation

ClinicalApplication	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Specify)
Pediatric
Small Organ(Specify)	P	P	P	P	P	BMDC (P)
Neonatal Cephalic	P	P	P	P	P	BMDC (P)
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	BMDC (P)
Transvaginal	P	P	P	P	P	BMDC (P)
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

under Appendix E

Additional Comments:

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

David A. Seymon

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

510(k) Number K981626

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

510 (k) Number (if known) : Device Name :

7.5C30 Curved Array Transducer

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

Mode of Operation

Clinical	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Application
Ophthalmic
Fetal	E	E	E	E	E	BMDC (E)
Abdominal	E	E	E	E	E	BMDC (E)
Intraoperative
(Specify)
Pediatric	E	E	E	E	E	BMDC (E)
Small Organ	E	E	E	E	E	BMDC (E)
(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	E	E	E	E	E	BMDC (E)
Laparoscopic
Musculo-skeletalConventional	E	E	E	E	E	BMDC (E)
Musculo-skeletalSuperficial
Other (specify)
N = new indication; P = previously cleared by FDA; E = added

under Appendix E Additional Comments:

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

Prescription Use (Per 21 CFR 801.109)

Thail G. Seyman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K 78/626

(

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

510 (k) Number (if

known) :

7.5L40 Linear Array Transducer Device Name :

Intended Use:

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

Mode of Operation

ClinicalApplication	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	BMDC (P)
Abdominal	P	P	P	P	P	BMDC (P)
Intraoperative(Specify)	P	P	P	P	P	BMDC (F)
Pediatric	P	P	P	P	P	BMDC (P)
Small Organ(Specify)	P	P	P	P	P	BMDC (P)
Neonatal Cephalic	P	P	P	P	P	BMDC (P)
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	BMDC (P)
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	BMDC (P)
Musculo-skeletalSuperficial
Other (specify)
N = new indication. D = previously cleared by FDA. E = added.

under Appendix E

Additional Comments:

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

Prescription Use (Per 21 CFR 801.109)

Hind G. Hyam

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

510(k) Number_K481626

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

510 (k) Number (if

known) :

7.5PL13 Phased Array Transducer Device Name :

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

Mode of Operation

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E	E	E	BMDC (E)
Abdominal	E	E	E	E	E	E	BMDC (E)
Intraoperative(Specify)
Pediatric	E	E	E	E	E	E	BMDC (E)
Small Organ(Specify)	E	E	E	E	E	E	BMDC (E)
Neonatal Cephalic	E	E	E	E	E	E	BMDC (E)
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	E	E	E	E	E	E	BMDC (E)
Laparoscopic
Musculo-skeletalConventional	E	E	E	E	E	E	BMDC (E)
Musculo-skeletalSuperficial
Other (specify)

N = new indication;

P = previously cleared by FDA;

E = added

under Appendix E

Additional Comments:

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

Thind le. Beynam

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

510(k) Number K981626

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.