SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM

K043016 · Siemens Medical Solutions USA, Inc. · IYN · Nov 16, 2004 · Radiology

Device Facts

• Record ID: K043016
• Device Name: SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended 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.

Device Story

Orchid is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via various transducers (phased, convex, linear arrays). The system processes these signals to display images in B-Mode, M-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Amplitude Doppler, Harmonic Imaging, or 3D imaging on a CRT display. It includes analysis packages for anatomical measurements and fluid flow quantification. Used in clinical settings by healthcare professionals for diagnostic purposes. Output is displayed on-screen to assist clinicians in diagnosis and clinical decision-making. Benefits include non-invasive visualization of internal structures and hemodynamics.

Clinical Evidence

Bench testing only. The device complies with safety standards including UL 60601-1, CSA C22.2 No. 601-1, and AIUM/NEMA standards for acoustic output and thermal/mechanical indices. Biocompatibility is verified per ISO 10993.

Technological Characteristics

Mobile, software-controlled diagnostic ultrasound system. Transducers: Phased Sector, Convex, and Linear Arrays. Imaging modes: B, M, PW/CW Doppler, Color/Amplitude Doppler, Harmonic, 3D. Connectivity: On-screen display of thermal/mechanical indices. Safety standards: UL 60601-1, IEC 60601-1-2, ISO 10993. Sterilization: Not specified (transducers).

Indications for Use

Indicated for diagnostic imaging or fluid flow analysis of the human body in general radiology, abdominal, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, urology, vascular, and musculoskeletal applications. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• SONOLINE Antares Diagnostic Ultrasound System with Clarify VE (K033196)
• SONOLINE G50&60 S Diagnostic Ultrasound Systems (K040060)
• SONOLINE G20 Diagnostic Ultrasound System (K040502)

Submission Summary (Full Text)

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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: [phone] [phone] 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

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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:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. 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 [phone].

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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | BMDC | Note 2,3 |
| Small Organ<br>(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<br>Conventional | | N | N | N | N | N | N | | BMDC | Note 2,3 |
| Musculo-skeletal<br>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

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

Daniel R. Lynn
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number K43016

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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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | N | N | N | | | Note 2,3 |
| Abdominal | | N | N | N | N | N | N | | BMDC | Note 2,3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | | Note 2,3 |
| Small Organ<br>(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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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

> (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, 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Abdominal | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Small Organ<br>(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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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

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

> > Prescription Use (Per 21 CFR 801.109)

David G. Lynn

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

June, 30, 2004

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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

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

David R. Larson

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

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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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Small Organ<br>(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<br>Conventional | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Musculo-skeletal<br>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

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

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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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

> (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 h. heznor

---

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

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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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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

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

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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Small Organ<br>(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<br>Conventional | | N | N | N | | N | N | | BMDC | Note 2,3 |
| Musculo-skeletal<br>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

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

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<br>(Specify) | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|---------------------------|--------------------|-----------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity Imaging | | Combined<br>(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<br>(Note 6) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | BMDC | Note 2,3 | |
| Small Organ<br>(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<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>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

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

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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | N | N | N | | BMDC | Note 2,3 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(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

> (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 R. Ingram

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

June, 30, 2004