Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Abdominal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. 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 Orchid 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, Harmonic Imaging, or 3D imaging on a CRT display.

AI/ML Overview

The provided 510(k) summary for the Siemens SONOLINE Orchid M Diagnostic Ultrasound System is for a general purpose diagnostic ultrasound system. As such, the acceptance criteria and study information provided are primarily focused on its substantial equivalence to predicate devices, adherence to safety standards, and intended uses, rather than performance metrics in a clinical diagnostic study with ground truth.

Therefore, the following information will be structured to reflect the content available in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (general-purpose diagnostic ultrasound), acceptance criteria are typically met through adherence to recognized national and international safety, performance, and acoustic output standards, as well as demonstration of substantial equivalence to already cleared devices. Clinical performance is implied by the successful implementation of these standards and the equivalence to predicate devices, rather than being expressed in specific diagnostic metrics like sensitivity or specificity from a diagnostic study.

Acceptance Criteria Category	Reported Device Performance (as per 510(k) Summary)
Safety Standards Adherence	UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA 1998 (Thermal and Mechanical Acoustic Output Indices), AIUM/NEMA UD-2 1998 (Acoustic Output Measurement), 93/42/EEC Medical Devices Directive, EN 60601-1, EN 60601-1-1, EN 60601-1-2, IEC 61157 (Acoustic Power), ISO 10993 (Biocompatibility)
Substantial Equivalence	Declared substantially equivalent to SONOLINE Antares (K033196), SONOLINE G50/G60 S (K040060), and SONOLINE G20 (K040502). All systems transmit ultrasound, post-process echoes for display, and allow specialized measurements and calculations.
Intended Use Compatibility	Capable of performing imaging for General Radiology, Abdominal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications, with measurement and analysis packages.
Transducer Compatibility	Compatible with P4-2 Phased Sector Array, CH5-2 Convex Array, VF10-5 Linear Array, L9-5 Linear Array, EC9-4 Convex Array Endocavity, EV9-4 Convex Array, VF13-5 Linear Array, P7-4 Phased Array, BE9-4 Convex Array, each with specific approved clinical applications and modes.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary provided does not describe a clinical performance study with a "test set" of patient data in the way one would for an AI/CADe device. Instead, the "testing" relates to engineering verification and validation against safety standards and benchmarks established by predicate devices. Therefore, there is no specific sample size of patient data mentioned for a test set.

The data provenance is thus not applicable in the context of clinical images for a diagnostic performance validation. The information refers to compliance with performance specifications derived from engineering tests and comparisons to existing ultrasound systems, rather than clinical 'data'.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As there is no clinical performance "test set" of patient data described with specific diagnostic outcomes, the concept of "ground truth" established by experts for such a set is not applicable to this 510(k) summary. The ground truth, in a broader sense, for the predicates and the new device is the established medical utility and safety of diagnostic ultrasound as a modality.

4. Adjudication Method for the Test Set

Again, because no clinical test set with specific diagnostic outcomes is detailed, an adjudication method for establishing ground truth is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This document describes a traditional diagnostic ultrasound system, not an AI or CADe (Computer-Aided Detection/Diagnosis) device. Therefore, no MRMC comparative effectiveness study was done regarding human readers improving with AI assistance. The device itself does not incorporate AI for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a diagnostic ultrasound system and does not implement a standalone algorithm for diagnostic interpretation without human input. Its function is to acquire and display real-time ultrasound data for a human operator to interpret.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this type of device clearance, the "ground truth" is not clinical diagnostic ground truth for specific cases. Instead, the clearance hinges on the device meeting established performance parameters (e.g., image quality, acoustic output, measurement accuracy from phantom or engineering tests) that are considered safe and effective, and demonstrating substantial equivalence to predicate devices that have themselves established a safe and effective "ground truth" for diagnostic imaging.
The document implicitly relies on the proven clinical utility and safety of predicate diagnostic ultrasound devices, supported by adherence to recognized engineering and safety standards.

8. The Sample Size for the Training Set

As this is a traditional diagnostic ultrasound system and not an AI/ML powered device, the concept of a "training set" of data for an algorithm is not applicable. The device's functionality is based on established ultrasound physics and signal processing, not learned patterns from a training dataset.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned, this point is not applicable.

Summary

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K043016

NOV 1 6 2004

510(K) SUMMARY

Orchid 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 Solutions USA, Inc., Ultrasound Division 22010 S.E. 51st Street Issaquah, WA 98029

Contact Person:

Patrick J Lynch Regulatory Affairs

Phone: (425) 557-1825 (425) 391-9198 FAX:

Date Prepared:

September 24, 2004

2. Proprietary Name:

SONOLINE Orchid M Diagnostic Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

21 CFR 892.1550
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:

K033196, 10/16/2003, SONOLINE Antares Diagnostic Ultrasound System with Clarify VE K040060, 01/28/2004, SONOLINE G50&60 S Diagnostic Ultrasound Systems K040502, 03/09/2004, SONOLINE G20 Diagnostic Ultrasound System

4. Device Description:

The Orchid, has been designed to meet the following product safety standards:

제 UL 60601-1, Safety Requirements for Medical Equipment
H CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
에 AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Accustic Output Indices on Diagnostic Ultrasound Equipment

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AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound H
위 93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment 내
- 내 EN 60601-1
- EN 60601-1-1
- I EN 60601-1-2
IEC 61157 Declaration of Acoustic Power ll
ISO 10993 Biocompatibility II

5. Intended Uses:

The Orchid ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

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:

The Orchid is substantially equivalent to the SONOLINE Antares, cleared via K033196, the SONOLINE G50/G60 S, cleared via K040060 and the SONOLINE G20, cleared via K040502. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

End of 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2004

Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 2501 Street NW BUFFALO MN 55313

Re: K043016

Trade Name: SONOLINE ORCHID 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 Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: October 29, 2004 Received: November 2, 2004

Dear Mr. Job:

.We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Transducer Model Number

P4-2 Phased Sector Array CH5-2 Convex Array

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VF10-5 Linear Array L9-5 Linear Array EC9-4 Convex Array Endocavity EV9-4 Convex Array VF13-5 Linear Array P7-4 Phased Array BE9-4 Convex Array

Ìf 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 Eederal 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 all the Act's requirements, 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 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:

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled,

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Page 3 - Mr. Job

"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 information on Jour respensional Consumer Assistance at its toll-free number (800) 638-204) or Nandracturers, 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,

Nancy C Brogdon

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

Enclosure(s)

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510(k) Number (if known):

Device Name: Intended Use:

SONOLINE ORCHID Diagnostic Ultrasound Systems

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)	Other(Specify)
Ophthalmic
Fetal		N	N	N	N	N	N		BMDC	Note 2,3
Abdominal		N	N	N	N	N	N		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		BMDC	Note 2,3
Small Organ(Note 1)		N	N	N	N	N	N		BMDC	Note 2,3
Neonatal Cephalic		N	N	N	N	N	N		BMDC	Note 3
Adult Cephalic		N	N	N	N	N	N		BMDC	Note 2
Cardiac		N	N	N	N	N	N		BMDC	Note 2,3
Transesophageal
Transrectal		N	N	N	N	N	N		BMDC	Note 2,3
Transvaginal		N	N	N	N	N	N		BMDC	Note 2,3
Transurethral
Intravascular
Peripheral vessel		N	N	N	N	N	N		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional		N	N	N	N	N	N		BMDC	Note 2,3
Musculo-skeletalSuperficial		N	N	N	N	N	N		BMDC	Note 2,3
Other (specify)

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

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Daniel R. Lynn
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number K43016

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

510(k) Number (if known):

Device Name:

Intended Use:

P4-2 Phased Sector Array Transducer for use with: SONOLINE ORCHID Diagnostic Ultrasound Systems 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)	Other(Specify)
Ophthalmic
Fetal		N	N	N	N	N	N			Note 2,3
Abdominal		N	N	N	N	N	N		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N			Note 2,3
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic		N	N	N	N	N	N		BMDC	Note 2,3
Cardiac		N	N	N	N	N	N		BMDC	Note 2,3
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

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

David A. Lyman
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices

510(k) Number K04301

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

510(k) Number (if known):

Device Name:

Intended Use:

CH5-2 Convex Array Transducer for use with: SONOLINE ORCHID Diagnostic Ultrasound Systems 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)	Other(Specify)
Ophthalmic
Fetal		N	N	N		N	N		BMDC	Note 2,3
Abdominal		N	N	N		N	N		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N		N	N		BMDC	Note 2,3
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

David G. Lynn

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

June, 30, 2004

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

510(k) Number (if known):

Device Name:

Intended Use:

VF10-5 Linear Array Transducer for use with: SONOLINE ORCHID Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation Clinical Application Color Color Amplitude Combined Other A B PWD CWD M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal Abdominal N N N N N BMDC Note 2,3 Intraoperative (Note 6) Intraoperative Neurological Pediatric N N N N N BMDC Note 2,3 Small Organ N N N N N BMDC Note 2,3 (Note 1) Neonatal Cephalic N N N N N BMDC Note 2,3 Adult Cephalic Cardiac Transesophageal Transrectai Transvaginal Transurethral Intravascular Peripheral vessel N N N N N BMDC Note 2,3 Laparoscopic Musculo-skeletal N N N N N BMDC Note 2,3 Conventional Musculo-skeletal N N N N N BMDC Note 2,3 Superficial Other (specify)

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

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

David R. Larson

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

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

510(k) Number (if known):

Device Name:

L9-5 Linear Array Transducer for use with: SONOLINE Orchid Diagnostic Ultrasound Systems

Intended Use:

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)	Other(Specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N		N	N		BMDC	Note 2,3
Small Organ(Note 1)		N	N	N		N	N		BMDC	Note 2,3
Neonatal Cephalic		N	N	N		N	N		BMDC	Note 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		BMDC	Note 2,3
Musculo-skeletalSuperficial		N	N	N		N	N		BMDC	Note 2,3
Other (specify)

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

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

David A. Layman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K043016

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

510(k) Number (if known):

Device Name:

Intended Use:

EC9-4 Convex Array Endocavity Transducer for use with: SONOLINE ORCHID Diagnostic Ultrasound Systems 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)	Other(Specify)
Ophthalmic
Fetal		N	N	N		N	N		BMDC	Note 2,3
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		BMDC	Note 2,3
Transvaginal		N	N	N		N	N		BMDC	Note 2,3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaqing

David h. heznor

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex Array Transducer for use with: SONOLINE ORCHID Diagnostic Ultrasound Systems 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)	Other(Specify)
Ophthalmic
Fetal		N	N	N		N	N		BMDC	Note 2,3
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		BMDC	Note 2,3
Transvaginal		N	N	N		N	N		BMDC	Note 2,3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Daniel h. Lyonn

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

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

510(k) Number (if known):

Device Name:

Intended Use:

VF13-5 Linear Array Transducer for use with: SONOLINE ORCHID Diagnostic Ultrasound Systems 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N		N	N		BMDC	Note 2,3
Small Organ(Note 1)		N	N	N		N	N		BMDC	Note 2,3
Neonatal Cephalic		N	N	N		N	N		BMDC	Note 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		BMDC	Note 2,3
Musculo-skeletalSuperficial		N	N	N		N	N		BMDC	Note 2,3
Other (specify)

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

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panorarnic imaging Note 4

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

David G. Lyman

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

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

510(k) Number (if known):

Device Name:

Intended Use:

P7-4 Phase Array Transducer for use with: SONOLINE ORCHID Diagnostic Uitrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation								Other(Specify)
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocity Imaging		Combined(Specify)
Ophthalmic
Fetal		N	N	N	N	N	N		BMDC	Note 2,3
Abdominal		N	N	N	N	N	N		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		BMDC	Note 2,3
Small Organ(Note 1)
Neonatal Cephalic		N	N	N	N	N	N		BMDC	Note 2,3
Adult Cephalic
Cardiac		N	N	N	N	N	N		BMDC	Note 2,3
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

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Danielle lyons

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

510(k) Number K043016

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

510(k) Number (if known):

Device Name:

Intended Use:

BE9-4 Convex Array Transducer for use with: SONOLINE ORCHID Diagnostic Ultrasound Systems 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)	Other(Specify)
Ophthalmic
Fetal		N	N	N	N	N	N		BMDC	Note 2,3
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N	N	N	N		BMDC	Note 2,3
Transvaginal		N	N	N	N	N	N		BMDC	Note 2,3
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

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

David R. Ingram

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

June, 30, 2004

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.