The Omnia X/XS ultrasound imaging system is intended for the following applications: General The Ommal XIXO ultraoberative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Kaulology, Abdominal, Intraoporative, Gular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

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

Device Description

The Omnia X/XS 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 primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.

AI/ML Overview

The provided document is a 510(k) Summary for the Siemens Omnia X/XS Diagnostic Ultrasound System, dated December 19, 2001. It outlines the device description, intended uses, and technological comparison to predicate devices for regulatory clearance.

This document does not contain information about acceptance criteria or specific studies showing device performance against such criteria. The "Indications for Use Form" (Attachments 4-20) lists the clinical applications each transducer is intended for and the available modes of operation, indicating whether these are "new" (N), "previously cleared" (P), or "added under Appendix E" (E) applications. However, these forms do not provide quantitative performance metrics, sample sizes, ground truth establishment, or details about study methodologies.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory classification and intended use rather than detailed performance study results.

Summary

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

FEB 1 3 2002

KU20553
Omnia X/XS Diagnostic Ultrasound System
510(k) Submission

510(K) SUMMARY

Omnia X/XS Diagnostic Ultrasound system

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance This Summaly of Salety and encercitose is promote as promote as provisions of a 510(k) Summary.

Submitted By: 1.

Siemens Medical Solutions USA, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98029

Contact Person:

Judi Hoffman Regulatory Affairs

Phone: (425) 557-1229 FAX: (425) 391-9198

Date Prepared: December 19, 2001

Proprietary Name: Omnia X/XS Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer

FR # 892.1550 FR # 892.1560 FR # 892.1570 Product Code 90-IYN Product Code 90-IYO Product Code 90-ITX

3. Predicate Device:

1 1945 773, 8/7/95, cleared as the Versa, marketed as the SONOLINE Versa/Versa Pro/Versa Plus/ Omnia with subsequent modifications.

1 165 Online Wared as Q4000, marketed as SONOLINE Elegra/Elegra Advances/Antares with subsequent modifications.

Device Description: বঁ

The Omnia X/XS, has been designed to meet the following product safety standards:

UL 2601-1, Safety Requirements for Medical Equipment 이
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment 에
AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic ■ Output Indices on Diagnostic Ultrasound Equipment

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

AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound 트
93/42/EEC Medical Devices Directive I
Safety and EMC Requirements for Medical Equipment 1
- EN 60601-1 트
- EN 60601-1-1 체
- EN 60601-1-2
IEC 1157 Declaration of Acoustic Power I
ISO 10993 Biocompatibility ■

Intended Uses: 5.

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

Technological Comparison to Predicate Device: 6.

The Omnia X/XS is substantially equivalent to the SONOLINE Versa, cleared via K945773, and The Online XXC is substantially oquivalism to the some features of the SONOLNE Elegra, modified will K902142, K002002, and K96183, K981626, K980557, K981528 and K001400. All cleared the RS40072, and moulined into patients, then perform post processing of received systems than and and only the paratomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

End of 510(k) Summary

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

Siemens Medical Solutions, USA % Mr. Mark Job TÜV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K020353

Trade Name: SONOLINE Omnia X/XS Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYN and IYO Dated: February 1, 2002 Received: February 4, 2002

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ronowed your bour secure in edevice is substantially equivalent (for the itelevelocu above and we nave asselosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Amendinents, of to devices and in. Act (Act). You may, therefore, market the device, subject to I could I ood, Drug, and Cosmons of the Act. The general controls provisions of the Act include the general connois pro ristins of all 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 This decommiation of our of our min X/XS Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C5-2 Convex Array C6-2 Convex Array C8-5 Convex Array 5.0C50+ Convex Array

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with r &cturer states uiters guirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special beening including 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.

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

The special report should reference the manufacturer's 510(k) number. It should be clearly and rne specificantly 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 I nis lotter will and in you wound substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please 11 you desire specific at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Jimit h. bymm

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

Attachment 4

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

SONOLINE Omnia X/XS (Versa Family) Ultrasound System

Device Name: Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC (P)	P	N
Abdominal		P	P	P	P	P	P		BMDC (P)	P	N
IntraoperativeAbdominal		P	P	P		P	P		BMDC (P)		N
IntraoperativeNeurological		P	P	P		P	P		BMDC (P)		N
Pediatric		P	P	P	P	P	P		BMDC (P)	P	N
Small Organ(Specify)**		P	P	P	P	P	P		BMDC (P)	P	N
Neonatal Cephalic		P	P	P	P	P	P		BMDC (P)		N
Adult Cephalic		P	P	P	P	P	P		BMDC (P)	P
Cardiac		P	P	P	P	P	P		BMDC (P)	P
Transesophageal		P	P	P		P	P		BMDC (P)	N	N
Transrectal		P	P	P		P	P		BMDC (P)	N	N
Transvaginal		P	P	P		P	P		BMDC (P)	N	N
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC (P)	P	N
Laparoscopic		P	P	P		P	P		BMDC (P)		N
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC (P)	P	N
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC (P)	N	N
Other (specify)

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

Additional Comments:

** small organs (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 A. Symm

cal De 510k) Numb

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

510(k) Number (if known):

Device Name: Intended Use:

C5-2 Convex Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal		E	E	E		E	E		BMDC (E)	E
Abdominal		E	E	E		E	E		BMDC (E)	E
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		E	E	E		E	E		BMDC (E)	E
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		E	E	E		E	E		BMDC (E)	E
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficialOther (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 C. Wegman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices KC16353

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

510(k) Number (if known):

Device Name: Intended Use:

C6-2 Convex Array Transducer for use with SONOLINE Omnia X/XS Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal		N	N	N		N	N		BMDC (N)	N	N
Abdominal		N	N	N		N	N		BMDC (N)	N	N
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		BMDC (N)	N	N
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N		BMDC (N)	N	N
Laparoscopic
Musculo-skeletalConventionalMusculo-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)

Torin A. Seymore

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

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

510(k) Number (if known):

Device Name: Intended Use: C8-5 Convex Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal
Abdominal		E	E	E		E	E		BMDC (E)
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		E	E	E		E	E		BMDC (E)		N
Small Organ(Specify)**		N	N	N		N	N		BMDC (N)		N
Neonatal Cephalic		E	E	E		E	E		BMDC (E)		N
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		BMDC (N)		N
Musculo-skeletalSuperficial
Other (specify)

| Other (opodiy)
N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments: _

** small organs (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 A. Leggiero

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

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

510(k) Number (if known):

5.0C50+ Convex Array Transducer for use with SONOLINE Omnia X/XS Device Name: Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC (P)		N
Abdominal		P	P	P	P	P	P		BMDC (P)		N
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		E	E	E	E	E	E		BMDC (E)		N
Small Organ(Specify)**		E	E	E	E	E	E		BMDC (E)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		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

Additional Comments:

** small organs (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 A. Lyman

(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

C6-3 3D Mechanically driven 3D Convex Array Transducer for use with SONOLINE Omnia X/XS for use with OONOERYE Of the human body as follows:

Mode of Operation Color 3D Combined Harmonic Clinical Application Amplitude Color Velocity PWD CWD A B M Imaging Imaging (Specify) Doppler Doppler Imaging Ophthalmic N BMDC (N) N ાર N N N Fetal N BMDC (N) N N N N N Abdominal Intraoperative Abdominal Intraoperative Neurological N N BMDC (N) N N N N Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal 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)

David G. Bergman

(Division Sign-Off) Division of Reproductive. Al and Radiological Devices 510(k) Number .

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

510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex Array Endovaginal Transducer for use with SONOLINE Omnia X/XS lor use with SONOEINE Offinia 9070
Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color 3D Combined Amplitude Harmonic Clinical Application Color Velocity PWD CWD B Imaging M (Specify) Imaging A Doppler Doppler Imaging Ophthalmic N N BMDC (N) N ત્વ N N N Fetal Abdominal Intraoperative Abdominal Intraoperative Neurological Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal N BMDC (N) N N N N N ನ Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal 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)

Prescription Use (Per 21 CFR 801.109)

Frant li. Bergman

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number .

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

510(k) Number (if known):

Device Name:

Intended Use:

Endo-VII Mechanical Sector Endovaginal Transducer for use with SONOLINE Omnia X/XS Tor use with SONOEINE Offinia AJAO
Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	B	M	Combined(Specify)	3DImaging
Ophthalmic
Fetal	N	N	BM (N)	N
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic	N	N	BM (N)	N
Adult Cephalic
Cardiac
Trans-esophageal				N
Transrectal	N	N	BM (N)	N
Transvaginal	N	N	BM (N)	N
Transurethral
Intravascular
Peripheral vessel
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) P WRITE BEEON THIS Office of Device Evaluation (ODE)

Camid A. Lyman

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _

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

510(k) Number (if known):

Device Name:

Intended Use:

Endo-V 3D Mechanical Sector Endovaginal Transducer for use with SONOLINE Omnia X/XS Tor use with SONOEINE Offinia 7070
Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal		N	N						BM (N)		N
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		N	N						BM (N)		N
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by 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. Styrman

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

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

510(k) Number (if known):

Device Name:

Intended Use:

EC9-4 Convex Array Endovaginal Transducer for use with SONOLINE Omnia X/XS for use with SONOENYE Official ATAUltrasound imaging or fluid flow analysis of the human body as follows:

						Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal		N	N	N		N	N		BMDC (N)	N	N
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		N	N	N		N	N		BMDC (N)	N	N
Transvaginal		N	N	N		N	N		BMDC (N)	N	N
Transurethral
Intravascular
Peripheral vessel
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)

David A. Segner

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

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

510(k) Number (if known):

Device Name: Intended Use:

5.0L45 Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal									BMDC (N)	N	N
Abdominal		N	N	N	N	N	N		BMDC (N)	N	N
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Specify)**		P	P	P	P	P	P		BMDC (P)	P	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC (P)	P	N
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC (P)	P	N
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

** small organs (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)

Daniel A. Legron

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number __

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

510(k) Number (if known):

Device Name: Intended Use:

7.5L70 Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	3DImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	N	N	N	N	N	BMDC (N)	N
Small Organ(Specify)**	P	P	P	P	P	BMDC (P)	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional	E	E	E	E	E	BMDC (E)	N
Musculo-skeletalSuperficial	E	E	E	E	E	BMDC (E)	N
Other (specify)

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

Additional Comments: _

** small organs (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 A. Hegemann

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _

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

510(k) Number (if known):

Device Name: Intended Use:

LB5-2 Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal		E	E	E		E	E		BMDC (E)
Abdominal		E	E	E		E	E		BMDC (E)
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficialOther (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)

Daniel A. Hegeman

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

510(k) Number (if known):

Device Name: Intended Use:

L10-5 Linear Array Transducer for use with SONOLINE Omnia X/XS E 10-5 Ellectif Array Transation of the human body as follows:
Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal										N	N
Abdominal		N	N	N		N	N		BMDC (N)	N
IntraoperativeAbdominal
IntraoperativeNeurological									BMDC (N)	N	N
Pediatric		N	N	N		N	N		BMDC (N)	N	N
Small Organ(Specify) **		N	N	N		N	N		BMDC (N)	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular									BMDC (N)	N	N
Peripheral vessel		N	N	N		N	N		BMDC (N)	N	N
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		BMDC (N)	N	N
Musculo-skeletalSuperficial		N	N	N		N	N		BMDC (N)	N	N
Other (specify)

Other (Spool))
N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

** small organs (breast, testes, thyroid, penis, prostate)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) I WRITE BELOW TITAO ERE SON evice Evaluation (ODE)

David A. Segmen

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

510(k) Number (if known):

VF13-5 Linear Array Transducer for use with SONOLINE Omnia X/XS Device Name: Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		BMDC (N)		N
Small Organ(Specify)**		E	E	E	E	E	E		BMDC (E)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		E	E	E	E	E	E		BMDC (E)		N
Laparoscopic
Musculo-skeletalConventional		E	E	E	E	E	E		BMDC (E)		N
Musculo-skeletalSuperficial		E	E	E	E	E	E		BMDC (E)		N
Other (specify)

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

Additional Comments: _

** small organs (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 A. Segerson

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

510(k) Number (if known):

Device Name: Intended Use: VF13-5SP Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal		N	N	N		N	N		BMDC (N)		N
IntraoperativeNeurological		N	N	N		N	N		BMDC (N)		N
Pediatric		N	N	N		N	N		BMDC (N)		N
Small Organ(Specify)**		N	N	N		N	N		BMDC (N)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N		BMDC (N)		N
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		BMDC (N)		N
Musculo-skeletalSuperficial		N	N	N		N	N		BMDC (N)		N
Other (specify)

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

Additional Comments: _

** small organs (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 A. Bergman

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

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

510(k) Number (if known):

Device Name: Intended Use: 7.5L50I Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal
Abdominal		E	E	E		E	E		BMDC (E)		N
IntraoperativeAbdominal		P	P	P		P	P		BMDC (P)		N
IntraoperativeNeurological
Pediatric
Small Organ(Specify) **		N	N	N		N	N		BMDC (N)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		E	E	E		E	E		BMDC (E)		N
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		BMDC (N)		N
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments: _

** small organs (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 A. Bergman

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _

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

510(k) Number (if known):

Device Name: Intended Use:

7.5L50Q Linear Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMDC (P)		N
IntraoperativeAbdominal		E	E	E		E	E		BMDC (E)		N
IntraoperativeNeurological
Pediatric
Small Organ(Specify) **		N	N	N		N	N		BMDC (N)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		E	E	E		E	E		BMDC (E)		N
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		BMDC (N)		N
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments: _

** small organs (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 A. Segerson

(Division Sign-Off) Dension of Reproductive, Abdomin od Radiological Devices a Pilid Number_

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

510(k) Number (if known):

Device Name: Intended Use:

LAP8-4 Laparoscopic Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal		P	P	P		P	P		BMDC (P)		N
IntraoperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic		P	P	P		P	P		BMDC (P)		N
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)

Elniel A. Segarra

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

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

510(k) Number (if known):

Device Name: Intended Use:

P4-2 Phased Sector Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal
Abdominal		E	E	E	E	E	E		BMDC (E)	E
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic		E	E	E	E	E	E		BMDC (E)	E
Cardiac		E	E	E	E	E	E		BMDC (E)	E
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
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)

David A. Segura

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

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

510(k) Number (if known):

Device Name: Intended Use:

5.0P10 Phased Sector Array Transducer for use with SONOLINE Omnia X/XS Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC (P)
Abdominal		P	P	P	P	P	P		BMDC (P)
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		BMDC (N)
Small Organ(Specify)
Neonatal Cephalic		P	P	P	P	P	P		BMDC (P)
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC (P)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
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)

David M. Severson

(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices + 10(k) Number _______________________________________________________________________________________________________________________________________________________________

{26}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

MPT7-4 Phased Sector Array TEE Transducer for use with SONOLINE Omnia X/XS Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	3DImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal		N	N	N		N	N		BMDC (N)	N	N
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
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)

David A. Hegmann

12/19/01

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.