Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diagnostic ultrasound system and does not mention AI, ML, or related terms in the device description, intended use, or performance study sections.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" and its intended use is for "diagnostic imaging or fluid flow analysis" and to provide "information that is used for clinical diagnosis purposes," not for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system provides "information that is used for clinical diagnosis purposes." Additionally, the "Device Description" categorizes the Orchid as a "diagnostic ultrasound system." The predicate devices listed also identify themselves as "Diagnostic Ultrasound Systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components for acquiring ultrasound data (transducer, processing unit, etc.), even though it is "software-controlled."

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
Device Description: The description clearly states that the Orchid is a diagnostic ultrasound system. Ultrasound uses sound waves to create images of structures inside the body. It does not involve testing samples taken from the body.
Intended Use: The intended use describes diagnostic imaging and fluid flow analysis of the human body. This is consistent with an in vivo (within the body) imaging device, not an in vitro diagnostic device.

Therefore, based on the provided information, the Orchid is a diagnostic imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

Clinical Application	Mode of Operation					Color Doppler	Amplitude Doppler	Combined (Specify)	Other (Specify)
Fetal	N	N	N	N	N	N	N	BMDC	Note 2,3
Abdominal	N	N	N	N	N	N	N	BMDC	Note 2,3
Pediatric	N	N	N	N	N	N	N	BMDC	Note 2,3
Small Organ (Note 1)	N	N	N	N	N	N	N	BMDC	Note 2,3
Neonatal Cephalic	N	N	N	N	N	N	N	BMDC	Note 3
Adult Cephalic	N	N	N	N	N	N	N	BMDC	Note 2
Cardiac	N	N	N	N	N	N	N	BMDC	Note 2,3
Transrectal	N	N	N	N	N	N	N	BMDC	Note 2,3
Transvaginal	N	N	N	N	N	N	N	BMDC	Note 2,3
Peripheral vessel	N	N	N	N	N	N	N	BMDC	Note 2,3
Musculo-skeletal Conventional	N	N	N	N	N	N	N	BMDC	Note 2,3
Musculo-skeletal Superficial	N	N	N	N	N	N	N	BMDC	Note 2,3

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

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

UL 60601-1, Safety Requirements for Medical Equipment
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Accustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment
EN 60601-1
EN 60601-1-1
EN 60601-1-2
IEC 61157 Declaration of Acoustic Power
ISO 10993 Biocompatibility

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

General Radiology, Abdominal, Small Parts (breast, testes, thyroid, penis, prostate, etc.), Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal Cephalic, Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Fetal, Transrectal, Transvaginal

Indicated Patient Age Range

Neonatal/Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K033196, K040060, K040502

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 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.

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

1

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

2

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

3

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,

4

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)

5

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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)
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N	N	N	N	BMDC	Note 2,3
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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)
Intraoperative
Neurological
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-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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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)
Intraoperative
Neurological
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-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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
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
(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-skeletal
Conventional		N	N	N		N	N	BMDC	Note 2,3
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	BMDC	Note 2,3
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
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.

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	BMDC	Note 2,3
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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-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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N	BMDC	Note 2,3
Musculo-skeletal
Superficial		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 | Color
Doppler | Amplitude
Doppler | Color
Velocity 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) | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
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.

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N	N	N	N	BMDC	Note 2,3
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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