SONOLINE G60 S ULTRASOUND SYSTEM

K052894 · Siemens Medical Solutions USA, Inc. · IYN · Nov 23, 2005 · Radiology

Device Facts

• Record ID: K052894
• Device Name: SONOLINE G60 S ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SONOLINE G60 S™ ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, 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

The SONOLINE G60 S is a multi-purpose diagnostic ultrasound system. It transmits ultrasonic energy into the body via a transducer; reflected echoes are processed to generate 2D images of anatomical structures and fluid flow. Doppler principles are utilized to display blood flow as a spectrum or color-coded 2D images. The system includes various transducers for specific clinical applications. It is used in clinical settings by healthcare professionals to perform measurements and analysis for diagnostic purposes. The system supports advanced imaging modes including Ensemble tissue harmonic imaging, 3D imaging, B&W/Power SieScape panoramic imaging, and contrast agent imaging. Output is displayed on-screen for clinician review to aid in clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. The device conforms to safety and performance standards including UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 (acoustic output), AIUM/NEMA UD-3 (thermal/mechanical indices), and ISO 10993 (biocompatibility).

Technological Characteristics

Multi-purpose diagnostic ultrasound system. Supports B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Color Velocity Imaging modes. Connectivity includes various transducer arrays (convex, linear, phased sector, endovaginal, TEE). Operates according to ALARA principles. Complies with IEC 1157, EN 60601-1, and EMC requirements. Software-based analysis packages for measurements.

Indications for Use

Indicated for ultrasound imaging or fluid flow analysis of the human body in clinical applications including abdominal, fetal, pediatric, small organ, neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, laparoscopic, and musculoskeletal (conventional/superficial). 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 G50 and SONOLINE G60 STM Diagnostic Ultrasound Systems (K040060)
• SONOLINE G20 Diagnostic Ultrasound System (K042833)
• SONOLINE Orchid Diagnostic Ultrasound System (K043016)
• ACUSO CV70 Cardiovascular System (K050240)

Submission Summary (Full Text)

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K052894
SONOLINE G60 S
TM Ultrasound System

Special 510(k) Submission

Siemens Medical Solutions USA, Inc. Ultrasound Division

### NOV 2 3 2005

#### SECTION 11

# 510(k) Summary of Safety and Effectiveness

| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Iskra Mraković<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Submission Date: | October 13, 2005 |
| Device Name: | SONOLINE G60 STM Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |

Classification:

Regulatory Class: II Review Category: Tier II Classification Panel: Radiology

21 CFR 892.1550

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

#### Predicate Device(s):

- # K040060 (January 28, 2004), cleared as SONOLINE G50™ and SONOLINE G60 . STM Diagnostic Ultrasound Systems.
- # K042833 (October 27, 2004), cleared as SONOLINE G20™ Diagnostic Ultrasound . System.
- # K043016 (November 16, 2004), cleared as SONOLINE Orchid™ Diagnostic . Ultrasound System.
- # K050240 (March 9, 2005), cleared as ACUSO CV70™ Cardiovascular System. .

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#### Device Description:

The G60S system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products that are already cleared for USA distribution under the following 510(k) PreMarket Notification number:

- # K040060 (January 28, 2004) cleared as SONOLINE G50TM and SONOLINE . G60 STM Ultrasound Systems.
The G60S ultrasound system has been designed to conform to the following product safety standards:

- UL 2601-1, Safety Requirements for Medical Equipment ●
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic ● Ultrasound
- AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Device Directive ●
- . Safety and EMC Requirements for Medical Equipment
- EN 60601-1 ●
- · EN 60601-1-1
- . EN 60601-1-2
- IEC 1157 Declaration of Acoustic Power ●
- ISO 10993 Biocompatibility .
- The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)

#### Intended Use:

The SONOLINE G60 S™ ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, 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.

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#### Technological Comparison to Predicate Device:

The G60S™ is substantially equivalent in its technologies and functionality to the SONOLINE G50™ and SONOLINE G60 S™ Diagnostic Ultrasound Systems that are already cleared under 510(k) premarket notification number K040060.

The G60S functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post-processing of received echoes is performed to generate twodimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations' functions.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

NOV 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Iskra Mrakovic Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393

Re: K052894

Trade Name: SONOLINE G60 STM Ultrasound System Regulation Number: 21 CFR 892.1550; 892.1560; 892.1570 Regulation Name: Ultrasonic pulsed Doppler imaging system; Ultrasonic pulsed echo imaging system; Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN; IYO; ITX Dated: October 13, 2005 Received: November 14, 2005

Dear Ms. Mrakovic:

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 G60 STM Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

C5-2; C6-2; C8-5; 5.0C50+; C6-3 3D; EV9-4; Endo-VII; Endo-V 3D; EC9-4; 5.0L45; 7.5L70; LB5-2; L10-5; VF13-5; VF13-5SP; 7.5L50I; 7.5L50Q; LAP8-4; P4-2; 5.0P10; MPT7-4; CW2; CW5; P9-4; CH5-2

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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.

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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, Marvland 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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:

#### SONOLINE G60 S™ Ultrasound System

Intended Use:

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

| Clinical Application | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative (Note 6) | | P | P | P | | P | P | | BMDC | Note 3 |
| Intraoperative Neurological | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ (Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,7 |
| Transesophageal | | P | P | P | E | P | P | | BMDC | Note 2,3,7 |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Laparoscopic | | P | P | P | | P | P | | BMDC | Note 3 |
| Musculo-skeletal (Conventional) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Musculo-skeletal (Superficial) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

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)

> > Prescription Use (Per 21 CFR 801.109)

Maneye Brogdon
ivision Sign-Off)
vision of Reproductive, Abdominal,
ad Rod

Radiological Devices
510(k) Number KA52894

Indications for Use Forms

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510(k) Number (if known):

Device Name:

Intended Use:

C5-2 Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2.3,4,5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; 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

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)

> > Prescription Use (Per 21 CFR 801.109)

Nancy C. Beardon

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Division Sign Division of Reproductive, Abdominal, and Radiological Devices 51(%) Number

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510(k) Number (if known):

Device Name:

Intended Use:

C6-2 Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System 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 | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; 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

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)

> > Prescription Use (Per 21 CFR 801.109)

Danny C. Brandon

(Division Sig Division of Reproductive, A and Radiological Device 510(k) Number

Section 6

Indications for Use Forms

Pg. 3 of 27

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510(k) Number (if known):

Device Name:

Intended Use:

C8-5 Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System 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 | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Intraoperative (Note 6) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Small Organ (Note 1) | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | E | E | E | | E | E | | BMDC | Note 3,4,5,7 | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Musculo-skeletal (Superficial) | | E | E | E | | E | E | | BMDC | Note 3,4,5 | |
| Other (specify) | | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; 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)

> > Prescription Use (Per 21 CFR 801.109)

Nancy C. Broughton

(Division Sign-Off Division of Reproc and Radio 510(k) Num

Indications for Use Forms

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510(k) Number (if known):

'

Device Name:

Intended Use:

5.0C50+ Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System 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 | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Small Organ (Note 1) | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | E | E | E | E | E | E | | BMDC | Note 3,4,5 |
| Musculo-skeletal (Superficial) | | E | E | E | E | E | E | | BMDC | Note 3,4,5 |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; 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 S 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)

Mauree Gordon

(DMsion Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052894

Section 6

Indications for Use Forms

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510(k) Number (if known):

Device Name:

C6-3 3D Mechanically Driven 3D Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System

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 Velocity Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | E | E | E | | E | E | | BMDC | Note 2,3,4,5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; 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)

> > Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Division Sign-Division of Reproductiv and Radiological Device 510(k) Number

Indications for Use Forms

------------------------------------------------------------------------------------

Pg. 6 of 27

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

.

### Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex Array Endovaginal Transducer for use with: SONOLINE G60 S Ultrasound System 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 | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | | | | | | | | | |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; 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)

> > Prescription Use (Per 21 CFR 801.109)

Nancy C. broadin

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number

\$\qquad\$ K052894

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for Use Forms

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

510(k) Number (if known):

Device Name:

#### Endo-VII Mechanical Sector Endovaginal Transducer for use with: SONOLINE G60 S Ultrasound System

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 | | P | P | | | | | | BM | Note 3 | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative Abdominal | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | | | | | | BM | Note 3 | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | BM | Note 3 | | |
| Transvaginal | | P | P | | | | | | BM | Note 3 | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; 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

Note 4 B&W SieScape panoramic imaging

Note S 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)

Vancy C. Hogdon
(Division Sign-Off)

Division of Reproductive, Abd and Radiological Devices 510(k) Number

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

510(k) Number (if known):

Device Name:

# Endo-V 3D Mechanical Sector Endovaginal Transducer for use with:

Intended Use:

SONOLINE G60 S Ultrasound System

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 | | P | P | | | | | | BM | Note 3 | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Note 6) | | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | | | | | | BM | Note 3 | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | BM | Note 3 | | | |
| Transvaginal | | P | P | | | | | | BM | Note 3 | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

. ... . . . . . . . . . . . . . . . . .

.. .. ...

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

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

Contrast agent imaging Note 7

> (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)

Nawyc trogdon
(Division Sign-Off)
Division of B

Division of Reproductive, Abdominal, and Radiological Devices ் 1 (k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

EC9-4 Convex Array Endovaginal Transducer for use with: SONOLINE G60 S Ultrasound System

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 | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | | | | | | | | | |
| Intraoperative Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note S 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)

Daveyc Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K052894

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

510(k) Number (if known):

Device Name:

Intended Use:

BE9-4 Convex Array Endocavity Transducer for use with: SONOLINE G60 S Ultrasound System

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 | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | | | | | | | | | |
| Intraoperative Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

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)

Nancy C Brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K062899

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

510(k) Number (if known):

Device Name:

Intended Use:

5.0L45 Linear Array Transducer for use with: SONOLINE G60 S Ultrasound System 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 | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ (Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note l 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)

> > Prescription Use (Per 21 CFR 801.109)

Mancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
Medical Devices
2052894

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for Use Forms

ﻟﻤﺴﺘﻌﻤﺎ ﻋﻠﻰ ﻣﻌﻬﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ

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

510(k) Number (if known):

Device Name:

7.5L70 Linear Array Transducer for use with: SONOLINE G60 S Ultrasound System

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 | | | | | | | | | | |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Small Organ (Note 1) | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac…