The SQNOLINE 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 contrast agent imaging will not add any new applications or 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.

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

The Siemens SONOLINE Elegra diagnostic ultrasound system, with the addition of Contrast Agent Imaging (CAI), did not involve specific acceptance criteria and performance data like a typical AI/ML medical device. This 510(k) submission (K981528) focuses on demonstrating substantial equivalence to a predicate device for an updated functionality (CAI and Harmonic Imaging) on an existing ultrasound system.

Therefore, many of the requested elements for AI/ML device studies are not applicable to this submission.

Here's a breakdown of what can be extracted and why other parts are not available:

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

This information is not provided in the 510(k) summary. For a traditional medical device like an ultrasound system, the "acceptance criteria" are typically related to meeting performance standards specified by the FDA (e.g., image quality, safety, acoustic output levels) rather than statistical performance metrics like sensitivity/specificity for a diagnostic AI algorithm. The 510(k) process focuses on demonstrating equivalence to a legally marketed predicate device.

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

Not applicable. This device is an imaging system, not an AI/ML algorithm that processes data for diagnostic output based on a test set of cases. The "testing" for such a system would involve validating its functionality and safety according to engineering and performance specifications, likely using phantoms and potentially clinical images, but not in the format of a "test set" for diagnostic performance validation.

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)

Not applicable. Ground truth establishment for a test set of diagnostic cases is relevant for AI/ML devices, not for the core functionality of an ultrasound imaging system in this context.

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

Not applicable. This pertains to AI/ML diagnostic performance evaluation.

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

Not applicable. This is not an AI-assisted diagnostic device, but rather an imaging system with an enhanced imaging mode (Contrast Agent Imaging). The submission does not describe a MRMC study.

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

Not applicable. This is not a standalone algorithm; it's a feature integrated into an ultrasound system, used by a human operator.

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

Not applicable. Ground truth for diagnostic performance is not the focus of this submission. The "ground truth" for an ultrasound system's performance typically refers to physical measurements and imaging of known structures (e.g., phantoms) to verify image quality and system accuracy.

8. The sample size for the training set

Not applicable. This refers to AI/ML model training data.

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

Not applicable. This refers to AI/ML model training data.

Summary of the Study and Device Information Provided (relevant to the 510(k) submission):

Device Name: SONOLINE Elegra Advanced / SONOLINE Elegra Diagnostic Ultrasound system (with Addition of Contrast Agent Imaging)

Study/Evaluation: The submission is a 510(k) Premarket Notification to demonstrate substantial equivalence to predicate devices for the addition of Contrast Agent Imaging (CAI) and Harmonic Imaging to an existing ultrasound system.

Predicate Devices:

Acuson Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option (K973767, 12/23/97)
SONOLINE Elegra (K945072, 11/21/95)

Technological Comparison (indicating how it meets implicit "acceptance criteria" for substantial equivalence):
The document states that both the SONOLINE Elegra and the predicate Acuson system are "full-featured, high-end diagnostic ultrasound systems capable of B-mode, M-mode, CW Doppler, Color Doppler, Amplitude Doppler, and combined imaging modes utilizing a number of transducers with varying center frequencies."

Crucially, "Both systems are modified to optimize images obtained with the use of diagnostic ultrasound and ultrasound contrast agents. Both systems employ modified transmit/receive functions which allow for enhanced imaging of tissues and structures which reflect the transmitted ultrasound at a harmonic, or multiple, of the transmit frequency."

This direct comparison of technological features and functions demonstrates that the new functionality of the SONOLINE Elegra (Contrast Agent Imaging and Harmonic Imaging) is substantially equivalent to that already cleared in a predicate device (Acuson Sequoia). The "acceptance criteria" here are essentially meeting the safety and efficacy profiles of the predicate device.

Safety Standards Endorsed:
The SONOLINE Elegra is designed to meet several safety standards, which implicitly serve as acceptance criteria for its overall operation:

UL 2601-1. Safety Requirements for Medical Equipment
CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment
Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.
93/42/EEC Medical Devices Directive EN60601 = (IEC 601-1+ IEC 601-1-2). Safety and EMC Requirements for Medical Equipment

Post-Clearance Requirement:
The FDA's clearance letter includes a condition that the manufacturer submit a post-clearance special report with "complete information, including acoustic output measurements based on production line devices." This indicates that safety (specifically acoustic output) is a key performance metric that must be continuously met, acting as an ongoing acceptance criterion.

This submission is a regulatory filing for an incremental upgrade to an existing ultrasound system, focusing on equivalence rather than detailed performance metrics for a novel diagnostic accuracy claim.

Summary

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OCT 28 1998 510(K) SUMMARY

K9815528

Addition of Contrast Agent 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. Contrast Agent Imaging (CAI) is a patented technique (US patent number 5,632,277).

Submitted Bv: 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

2. Proprietary Name:

SONOLINE Elegra Advanced SONOLINE Elegra

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

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

3. Predicate Device:

. Acuson Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option (K973767, 12/23/97)
. SONOLINE Elegra (K945072, 11/21/95).

4. Device Description:

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

UL 2601-1. Safety Requirements for Medical Equipment
CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment
Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.

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

93/42/EEC Medical Devices Directive EN60601 = (IEC 601-1+ IEC 601-1-2). Safety and EMC Requirements for Medical Equipment

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.

6. Technological Comparison to Predicate Device:

Both the SONOLINE Elegra and the predicate device from Acuson are full-featured, highend diagnostic ultrasound systems capable of B-mode, M-mode, CW Doppler, Color Doppler. Amplitude Doppler, and combined imaging modes utilizing a number of transducers with varying center frequencies.

Both systems are modified to optimize images obtained with the use of diagnostic ultrasound and ultrasound contrast agents.

Both systems employ modified transmit/receive functions which allow for enhanced imaging of tissues and structures which reflect the transmitted ultrasound at a harmonic, or multiple, of the transmit frequency.

End of 510(k) Summary

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing the wings and body. The eagle is facing to the right.

OCT 28 1998

Steve Hesler Manager of Regulatory Affairs Siemens Medical Systems, Inc. Ultrasound Group

22010 S.E. 51st St. Issaquah, WA 98029-7002

Re: K981528 Trade Name: Sonoline Elegra and Elegra Advanced Diagnostic Ultrasound System (with Harmonic Imaging) Regulatory Class: II Product Code: 90 IYO/21 CFR 892.1560 Dated: October 7, 1998 Received: October 9, 1998

Dear Mr. Hesler:

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 probes intended for use with the Sonoline Elegra and Elegra Advanced Diagnostic Ultrasound System, as described in your premarket notification:

Probes Model Number

2.5PL20 Phased Array 3.5PL28 Phased Array 3.5C40 Curved Array 5.0HDPL40 Linear Array 5.0C50 Curved Array 6.5EC10 Curved Array 6.5EV13 Curved Array 7.5C30 Curved Array 7.5L40 Linear Array 7.5PL13 Phased 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 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Steve Hesler

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 investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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 594-1212,

Sincerely yours,

Gerald li. Segman

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

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Attachment 1

Ultrasound Device Indications Statement

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

K981528 SONOLINE Elegra/Elegra Advanced See below

Mode of Operation

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (Specify)	Harmonic Imaging
Ophthalmic
Fetal	P	P	P	P	P	P	P	BMDC (P)	N
Abdominal	P	P	P	P	P	P	P	BMDC (P)	N
Intraoperative(Specify) *	P	P	P	P	P	P	P	BMDC (P)
Pediatric	P	P	P	P	P	P	P	BMDC (P)	N
Small Organ(Specify) **	P	P	P	P	P	P	P	BMDC (P)	N
NeonatalCephalic	P	P	P	P	P	P	P	BMDC (P)
Adult Cephalic	P	P	P	P	P	P	P	BMDC (P)
Cardiac	P	P	P	P	P	P	P	BMDC (P)	N
Trans-esophageal
Transrectal	P	P	P	P	P	P	P	BMDC (P)
Transvaginal	P	P	P	P	P	P	P	BMDC (P)	N
Transurethral
Intravascular
Peripheralvessel	P	P	P	P	P	P	P	BMDC (P)	N
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P	BMDC (P)	N
Musculo-skeletalSuperficial	P	P	P	P	P	P	P	BMDC (P)	N
Other (specify)

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

Additional Comments:

= intraoperative (abdominal, neurological)

** = small organs (breast,testes, thryoid, penis,prostate)

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

Daniel A. Sypem

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

510(k) Number K981528

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

510 (k) Number (if known) :

Device Name :

K981528 2.0 CW probe for use with SONOLINE Elegra/Elegra Advanced

Intended Use:

Device Name:		2.5 CW probe for use with Sonoline Glegra & Glegra Advanced
Intended Use:		See below
Mode of Operation
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal				P
Abdominal				P
Intraoperative(Specify)				P
Pediatric				P
Small Organ(Specify)				P
Neonatal				P
Cephalic				P
Adult Cephalic				P
Cardiac				P
Trans-esophageal
Transrectal				P
Transvaginal				P
Transurethral
Intravascular
Peripheralvessel				P
Laparoscopic
Musculo-skeletalConventional				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 b. Segner

(Divisio Sign-Off Division of Reproductive, Abdominal, ENT and Radiological Devi

510(k) Number

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

510 (k) Number (if known) :

K981528

Device Name: 25PL20 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced
Intended Use: See below.
	Mode of Operation
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	E	E	E	E	E	E	E		BMDC (E)	N
Abdominal	E	E	E	E	E	E	E		BMDC (E)	N
Intraoperative(Specify)
Pediatric	E	E	E	E	E	E	E		BMDC (E)	N
Small Organ(Specify)
Neonatal	E	E	E	E	E	E	E		BMDC (E)
CephalicAdult	E	E	E	E	E	E	E		BMDC (E)
CephalicCardiac	E	E	E	E	E	E	E		BMDC (E)	N
Transesophageal
Transrectal
Transvaginal										N
Transurethral
Intravascular
Peripheralvessel	E	E	E	E	E	E	E		BMDC (E)	N
Laparoscopic
Musculo-skeletal
ConventionalMusculo-skeletal
Superficial
Other(Specify)
	N = new indication; Additional Comments:P = previously cleared by FDA; E = added under Appendix E

2.5PL20 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced Device Name : See helow

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

Jamil le. Sezmm

(Divis on Sign-Off) Reproductive, Abdominal, El Divisio and Radiological De

510(k) Number K981528

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

Device Name: 3.5PL28 Phased Array Transducer for use with SONOLINE Elegra/Elegra AdvancedIntended Use: See below.
Mode of Operation
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P		BMDC (P)	N
Abdominal	P	P	P	P	P	P	P		BMDC (P)	N
Intraoperative(Specify)
Pediatric	P	P	P	P	P	P	P		BMDC (P)	N
Small Organ(Specify)
NeonatalCephalic	P	P	P	P	P	P	P		BMDC (P)
Adult Cephalic	P	P	P	P	P	P	P		BMDC (P)
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheralvessel	P	P	P	P	P	P	P		BMDC (P)	N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)
N = new indication; P = previously cleared by FDA; E = added under Appendix E

510 (k) Number (if known) : K981528

Device Name :

3.5PL28 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced

Trans-
esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Specify)

P	P	P	P	P	P	BMDC (P)	N

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 li. Leymm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

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

510 (k) Number (if known) : K981528

Device Name :

Intended Use:

3.5C40 Curved Array Transducer for use with SONOLINE Elegra/Elegra Advanced See below

Mode of Operation
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal		E	E	E		E	E		BMDC (E)	N
Abdominal		E	E	E		E	E		BMDC (E)	N
Intraoperative(Specify)
Pediatric		E	E	E		E	E		BMDC (E)	N
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheralvessel		E	E	E		E	E		BMDC (E)	N
Laparoscopic
Musculo-skeletalConventional		E	E	E		E	E		BMDC (E)	N
Musculo-skeletalSuperficial
Other (Specify)
N = new indication;Additional Comments:						P = previously cleared by FDA;			E = added under Appendix E

ﻪ: ﺑ

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

David A. Seymann

Sign-Off Reproductive, Abdominal, EN and Ra

Radiological Devices
510(k) Number K981528

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

Ultrasound Device Indications Statement
510 (k) Number (if known) :	K981528
Device Name :	5.0HDPL40 Linear Array Transducer for use with SONOLINE Elegra/Elegra
	Advanced
Intended Use:	See below
Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Harmonic Imaging
Ophthalmic
Fetal		P	P	P		P	P		BMDC (P)	N
Abdominal		P	P	P		P	P		BMDC (P)	N
Intraoperative (Specify)
Pediatric		P	P	P		P	P		BMDC (P)	N
Small Organ (Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC (P)	N
Laparoscopic
Musculo-skeletal		P	P	P		P	P		BMDC (P)	N
Conventional
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)

Elnil A. Syverson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

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

K981528

Device Name :

5.0C50 Curved Array Transducer for use with SONOLINE Elegra Elegra Advanced See below

ClinicalApplication	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	BMDC (P)	N
Abdominal	P	P	P	P	P	BMDC (P)	N
Intraoperative(Specify)
Pediatric	P	P	P	P	P	BMDC (P)	N
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheralvessel	P	P	P	P	P	BMDC (P)	N
Laparoscopic
Musculo-skeletal	P	P	P	P	P	BMDC (P)	N
Conventional
Musculo-skeletal
Superficial
Other (Specify)

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

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

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

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

510 (k) Number (if known) : K981528

Device Name : Intended Use: 6.5EC10 Curved Array Transducer for use with SONOLINE Elegra/Elegra Advanced See below

Mode of Operation

ClinicalApplication	B	M	PWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
Intraoperative(Specify)
Pediatric
Small Organ(Specify) **	E	E	E	E	E		BMDC (E)	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal	E	E	E	E	E		BMDC (E)
Transvaginal	E	E	E	E	E		BMDC (E)	N
Transurethral
Intravascular
Peripheralvessel
Laparoscopic
Musculo-skeletal
ConventionalMusculo-skeletal
Superficial
Other (Specify)
N = new indication;				P = previously cleared by FDA;		E = added under Appendix E
Additional Comments:

** =small organ (breast, testes, thyroid, penis, prostate)

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

David h. Syverson

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

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

K981528

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

6.5EV13 Curved Array Transducer for use with SONOLINE Elegra/Elegra Advanced Intended Use: See below

Mode of Operation
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
Intraoperative(Specify)
Pediatric
Small Organ(Specify) **		P	P	P		P	P		BMDC (P)	N
Neonatal		P	P	P		P	P		BMDC (P)
Cephalic
Adult Cephalic
Cardiac
Trans- esophageal
Transrectal		P	P	P		P	P		BMDC (P)
Transvaginal		P	P	P		P	P		BMDC (P)	N
Transurethral
Intravascular
Peripheralvessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Specify)
N = new indication;						P = previously cleared by FDA;			E = added under Appendix E
Additional Comments:
** =small organ (breast, testes, thyroid, penis, prostate)

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

Elmer A. Leyson

(Division Sign-Off) Division of Repreductive, Abdominal, ENT and Radiological De

510(k) Number K981528

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

510 (k) Number (if known) :

Device Name : Intended Use: K981528 7.5C30 Curved Array Transducer for use with SONOLINE Elegra Elegra Advanced See below

of Operatio

Mode of Operation
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal		E	E	E		E	E		BMDC (E)	N
Abdominal		E	E	E		E	E		BMDC (E)	N
Intraoperative(Specify)
Pediatric		E	E	E		E	E		BMDC (E)	N
Small Organ(Specify) **		E	E	E		E	E		BMDC (E)	N
Neonatal
Cephalic
Adult
Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheralvessel		E	E	E		E	E		BMDC (E)	N
Laparoscopic
Musculo-skeletal		E	E	E		E	E		BMDC (E)	N
ConventionalMusculo-skeletal
Superficial
Other(Specify)
N = new indication;						P = previously cleared by FDA;		E = added under Appendix E

Additional Comments:

** =small organ (breast, testes, thyroid, penis)

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

David A. Lynam

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

510(k) Number K981528

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

510 (k) Number (if known) : K981528

Device Name :

7.5L40 Linear Array Transducer for use with SONOLINE Elegra/Elegra Advanced See below

Intended Use: Ande of Operation

Mode of Operation
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal		P	P	P		P	P		BMDC (P)	N
Abdominal		P	P	P		P	P		BMDC (P)	N
Intraoperative(Specify) *		P	P	P		P	P		BMDC (P)
Pediatric		P	P	P		P	P		BMDC (P)	N
Small Organ(Specify) **		P	P	P		P	P		BMDC (P)	N
Neonatal		P	P	P		P	P		BMDC (P)
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheralvessel		P	P	P		P	P		BMDC (P)	N
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC (P)	N
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC (P)	N
Other (Specify)
N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

= intraoperative (abdominal, neurological)

** =small organ (breast, testes, thyroid, penis)

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

David le Symm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

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

510 (k) Number (if known) :

Device Name : Intended Use:

K981528 7.5PL13 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced See below

, -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Mode of OperationClinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal	E	E	E	E	E	E	BMDC (E)	N
Abdominal	E	E	E	E	E	E	BMDC (E)	N
Intraoperative(Specify)
Pediatric	E	E	E	E	E	E	BMDC (E)	N
Small Organ(Specify) **	E	E	E	E	E	E	BMDC (E)	N
Neonatal	E	E	E	E	E	E	BMDC (E)
Cephalic
Adult
Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheralvessel	E	E	E	E	E	E	BMDC (E)	N
LaparoscopicMusculo-skeletal	E	E	E	E	E	E	BMDC (E)	N
ConventionalMusculo-skeletalSuperficial
Other(Specify)
N = new Indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

** = small organ (breast, testes, thyroid, penis)

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

Gavid G. Sigman
(Division Sign Off)

eproductive, Abdominal, EN and R 510(k) Number

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.