SONOSITE MAXX SERIES ULTRASOUND SYSTEM

K082098 · Sonosite,Inc. · IYN · Aug 25, 2008 · Radiology

Device Facts

• Record ID: K082098
• Device Name: SONOSITE MAXX SERIES ULTRASOUND SYSTEM
• Applicant: Sonosite,Inc.
• Product Code: IYN · Radiology
• Decision Date: Aug 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

The device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications: Ophthalmic, Adult Cephalic, Fetal - OB/GYN, Trans-rectal, Abdominal, Trans-vaginal, Intra-operative (Abdominal organs and vascular), Musculo-skel. (Conventional), Intra-operative (Neuro.), Musculo-skel. (Superficial), Laparoscopic, Cardiac Adult, Pediatric, Cardiac Pediatric, Small Organ (breast, thyroid, testicles, prostate), Trans-esophageal (card.), Neonatal Cephalic, Peripheral vessel.

Device Story

SonoSite Maxx Series is a software-controlled diagnostic ultrasound system. It acquires high-resolution, real-time ultrasound data using various transducers. Modes include 2D, 2D Chroma, THI, M-Mode, PW/CW Doppler, Color Power/Velocity Doppler, Anatomical/Color M-Mode, PW/Color Tissue Doppler, Elastography, Strain Rate, tissue 4D, and flow 3D. Used in clinical settings by physicians/technicians for diagnostic imaging and fluid flow analysis. Output is displayed for clinical decision-making, aiding in diagnosis and procedural guidance (e.g., needle/catheter placement). Includes SiteLink Image Manager for PC download and DICOM/Clips Bundle for image management/quantification.

Clinical Evidence

Bench testing only. The device was verified and validated according to the manufacturer's design control process, conforming to 21 CFR 820, ISO 9001:2000, and ISO 13485. Compliance with electromedical safety standards was verified through independent evaluation.

Technological Characteristics

Software-controlled diagnostic ultrasound system. Supports multiple imaging modes (2D, Doppler, M-Mode, 3D/4D, Elastography). Connectivity includes DICOM and PC-based image management. Transducers are provided for various clinical applications. Conforms to electromedical safety standards.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body across various clinical applications including ophthalmic, fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel. 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

• SonoSite Maxx™ Series Ultrasound System (K071134)
• SonoSite MicroMaxx® Ultrasound System (K053069)
• SonoSite MicroMaxx® Ultrasound System (K043559)
• Philips Medical Systems HDP 5000 Ultrasound System (K034003)
• Philips Medical Systems HDP 5000 Ultrasound System (K011224)
• GE Logiq 9 Ultrasound System (K061129)

Submission Summary (Full Text)

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Image /page/0/Picture/22 description: The image shows the logo for SonoSite. The logo consists of a stylized, abstract symbol above the word "SonoSite." The symbol is a dark, curved shape that resembles a stylized "S" or a swirling motion. The word "SonoSite" is written in a serif font, with the letters slightly spaced apart.

AUG 2 5 2008

SonoSite, Inc. 21949 30th Drive SF Bothell, WA 98021-3904 USA

Telephone:[phone] Facsimile:1 425.951.1201 www.sonnsite.com

### 510(K) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

### 1) Submitter's name, address, telephone number, contact person:

SonoSite, Inc., 21919 30th Drive SE, Bothell, WA 98021-3904 USA

| Corresponding Official: | Christopher J. Hartzog, Sr. Regulatory Affairs Specialist |
|-------------------------|-----------------------------------------------------------|
| E-mail: | chris [e-mail] |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date prepared: | July 1, 2008 |

- 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name Diagnostic Ultrasound System with Accessories

Proprietary Name

SonoSite Maxx™ Series Ultrasound System (subject to change)

Classification Names

| Name | FR Number | Product Code |
|---------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Picture Archiving And Communications System | 892.2050 | 90-LLZ |

### 3) Identification of the predicate or legally marketed device:

SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx™ Series Ultrasound System (K071134), the SonoSite MicroMaxx® Ultrasound System (K053069 and K043559), the Philips Medical Systems HDP 5000 Ultrasound System (K034003 and K011224) and the GE Logiq 9 Ultrasound System (K061129),

### 4) Device Description:

The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, 2D Chroma, THI, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler, Anatomical M-Mode, Color M-Mode, Pulsed Wave Tissue Doppler Imaging (PW-TDI), Color Tissue Doppler Imaging (Color-TDI), Elastography (Strain), Strain Rate Imaging, tissue 4D and flow 3D imaging or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections.

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### 5) Indications for Use

The device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications:

| Ophthalmic | Adult Cephalic |
|-------------------------------------------------------|------------------------------|
| Fetal - OB/GYN | Trans-rectal |
| Abdominal | Trans-vaginal |
| Intra-operative<br>(Abdominal organs and vascular) | Musculo-skel. (Conventional) |
| Intra-operative (Neuro.) | Musculo-skel. (Superficial) |
| Laparoscopic | Cardiac Adult |
| Pediatric | Cardiac Pediatric |
| Small Organ<br>(breast, thyroid, testicles, prostate) | Trans-esophageal (card.) |
| Neonatal Cephalic | Peripheral vessel |

### 5) Comparison with Predicate Devices

The SonoSite Maxx™ Series Ultrasound System is of a comparable type and substantially equivalent to the current SonoSite Maxx™ Series Ultrasound System. It has the same technological characteristics, safety and effectiveness features, the same physical design and materials. The system has the same intended use and basic operating modes as the SonoSite, Philips HD15000 and GE Logiq 9 predicate devices.

### 6) Performance Data

The device is verified and validated according to the company's design control process.

### 7) Conclusion

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The product development process conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable electromedical device safety standards with compliance verified through independent evaluation and ongoing factory audits. Medical diagnostic ultrasound has an established history of safety and effectiveness. It is the opinion of SonoSite, Inc. that the SonoSite Maxx™ Series Ultrasound System is substantially equivalent with regard to safety and effectiveness to other devices already cleared for marketing.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.

### Public Health Service

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

### AUG 2 5 2008

SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street NW BUFFALO MN 55313

Re: K082098

Trade/Device Name: SonoSite Maxx™ Series Ultrasound System (SiteLink™ Image Manager and SonoSite® DICOM/Clips Bundle) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LLZ Dated: July 24, 2008 Received: July 25, 2008

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 SonoSite Maxx™ Series Ultrasound System (SiteLink™ Image Manager and SonoSite® DICOM/Clips Bundle), as described in your premarket notification:

### Transducer Model Number

| BPTRTx/8-5 | D5x/5 | ICTx/8-5 |
|------------|-------------|-----------|
| C8x/8-5 | C60x/5-2 | L25x-13-6 |
| C11x/8-5 | HFL38x/13-6 | L38x/10-5 |
| D2x/2 | HFL50x/15-6 | L52x/10-5 |

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

| LAPx/12-5 | TCDx/2 | WC40x/6-2 |
|--------------|------------|-------------|
| MiniTEEx/7-3 | TEEx/8-3 | WC60x/6-2 |
| P10x/8-4 | L25Bx/10-5 | WI.25x/12-5 |
| P17x/5-1 | LFL38x/7-3 | WL40x/12-5 |
| P21x/5-1 | P21Dx/5-1 | WMC15x/12-4 |
| SLAx/13-6 | P21MCx/5-1 | WMC20x/12-4 |
| SLTx/10-5 | P21Sx/7-1 | WTVx/9-3 |

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

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

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

"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 Andrew Kang, M.D. at [phone].

Sincerely yours,

Noyn M. Why

( 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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# K082098

### Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form – SonoSite Maxx™ Series Ultrasound System

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------------|------------------|
| Transducer: | N/A | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | P | P | P | | P | B+M; B+PWD;<br>B+CD | |
| Fetal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Abdominal<br>Intra-operative (Abdominal<br>organs and vascular) | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Intra-operative (Neuro.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Laparoscopic | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Pediatric<br>Small Organ (breast, thyroid,<br>testicles, prostate) | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Neonatal Cephalic | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Adult Cephalic | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-rectal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-vaginal<br>Trans-urethral | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Musculo-skel. (Superfic.)<br>Intra-luminal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Other (spec.) | | | | | | | |
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.)<br>Other (spec.) | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Peripheral vessel<br>Other (spec.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |

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

### Additional Comments:

ker : One coper coper copie, 2-04 mont insuna mayn, Sonde chockers mayin, Sonde conte conte conte conte conte conte conte conte conte conter mange contracioner or propor or measurements on recalled Images.

All items marked "P" were previously cleared in 510(k) K071134. (DiviSiON

Prescription Use (Per 21 CFR 801.109)

huzd In Whhy

Division of Reproductive, Abdominal and

Indications for Use

Radiological J10(k) Number

Section 4.3

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

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: SiteLink™ Image Manager

Indications for Use: SiteLink™ Image Manager is a software accessory for SonoSite Maxx Series medical diagnostic ultrasound systems. SiteLink enables image download, in full resolution .bmp format or compressed .jpg format, from SonoSite systems to a Windows-based PC.

ਡ Over-The-Counter Use: Prescription Use: or (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Arpitk Whan
(Division Sign-Off)

ion of Reproductive, Abdominal and ological Devices J(k) Number __

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

### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: SonoSite® DICOM/Clips Bundle

Indications for Use: The SonoSite® DICOM/Clips Bundle is a software option available on SonoSite Maxx Series™ medical diagnostic uitrasound systems. It is intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

| Prescription Use: | <span style="text-decoration: underline;"><b> </b></span> \u2713 or Over-The-Counter Use: <span style="text-decoration: underline;"><b> </b></span> \u25a1 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | (Part 21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Vorich Whing
(Division Sign-Off)

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

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

## 082010

## Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form – BPTRTx/8-5 Transducer

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|-------------------|---------------------|------------------|
| Transducer: | BPTRTx/8-5 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows: | | | | | | |
| Clinical Application | | | | | Mode of Operation | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>testicles. prostate) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-vaginal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |

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

### Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Doppler, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMB compound imaging (TD), elastography imaging, strain rate imaging, imaging, imaging to asist in the placement of needles and cather in vascular or other and courses. Color Dopler includes velocity color Doppler. Color Doppler Color Doppler Color Doppler Color Do

All items marked "P" were previously cleared in 510(k) K071134.

Hopal M. Whting

n of Reproductive, Abdominal and

iological Devices
510(k) Number K08

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

K082098

## Table 4.3- 3 Diagnostic Ultrasound Indications for Use Form – C8x/8-5 Transducer

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|-----|-----|------------------|---------------------|------------------|
| Transducer: | C8x/8-5 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | | | |
| Clinical Application | | Mode of Operation | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid, testicles. prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-vaginal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |

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

### Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Doppier, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMB compound imaging, tissue Dopler imaging, strain rate imaging, imaging for guidance of biopsy and imaging to assist in the placement of needles and cather in vascular or other anatomical stuctures. Color Doppler Color Doppler. Color Doppler can be combined with any imaging mode. M-Mode includes anatomical M-Mode, and color M-Mode.

All items marked "P" were previously cleared in 510(k) K071134.

Irmin In Why

tive. Abdominal and

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

Kof2098

## Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form - C11x/8-5 Transducer

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|---------------|----------------------------|---------------|
| Transducer: | C11x/8-5 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 |
| Intra-operative (Neuro.) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 |
| Neonatal Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 |
| Other (spec.) | | | | | | | |

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

### Additional Comments:

Not 1: Ohe includes color power Dopler, Copler, Clarkeringing, Sonces/Sonol inaging, Sonces/SonoHinaging, Sonces/Sonolfor insging, velocity color Doppier. Color Doppler can be combined with any imaging mode. M-Mode, and color M-Mode.

All items marked "P" were previously cleared in 510(k) K071134.

(Divisio productive. Abdominal a Radiolo 510 (k) Nur

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

# K082098

## Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form - D2x/2 Transducer

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer: | D2x/2 MHz Dual Element Circular Array | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid, testicles. prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | P | | | |
| Cardiac Pediatric | | | | P | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |

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

### Additional Comments:

All items marked "P" were previously cleared in 510(k) K071134.

Arastm Wh

(Division Sign-Off) ിടിഠന Sign Olym Only adiological Devices 510(k) Number -

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

K082098

## Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form – D5x/5 Transducer

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer: | D5x/5 MHz Dual Element Circular Array | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid, testicles. prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | P | | | |
| Cardiac Pediatric | | | | P | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |

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

### Additional Comments:

All items marked "P" were previously cleared in 510(k) K071134.

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

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

1<082098

| Table 4.3- 7 Diagnostic Ultrasound Indications for Use Form - C60x/5-2 Transducer | | | |
|-----------------------------------------------------------------------------------|--|--|--|
| | | | |

| System: | | SonoSite Maxx™ Series Ultrasound System | | | | | |
|----------------------------------------------------|---|---------------------------------------------------------------------------------------|-----|-----|---------------|---------------------|---------------|
| Transducer: | | C60x/5-2 MHz Transducer | | | | | |
| Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Abdominal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Neuro.)<br>Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Small Organ (breast, thyroid, testicles, prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Other (spec.) | | | | | | | |

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

### Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Dopler, 3-D/4-D imaging, tissue harmonic imaging, SonoRes/SonoHD imaging, SonoMB compound imaging (IDI), elastography imaging, strain rate imaging, imaging guidance for peripheral neve block procedures, inaging of spiral cord or central nere block procedures, inaging to guidace of biops and in the placement imaging mode. M-Mode includes anatomical M-Mode, and color M-Mode.

All items marked "P" were previously cleared in 510(k) K071134.

***_***а, а также и другие.

visit radio 510/k)

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

## Co82098

## Table 4.3- 8 Diagnostic Ultrasound Indications for Use Form - HFL38x/13-6 Transducer

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | |
|----------------------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------|-----|-----|------------------|---------------------|------------------|
| Transducer: | HFL38x/13-6 MHz Transducer | | | | | | |
| Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Other (spec.) | | | | | | | |

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

### Additional Comments:

Not 1: Other include color power Doper, S-04-0 imaging, itsue hamoni maging, SonoResSoonHinaging,
Sondal conporimaging (TD), alstorany inaging, strain and ing guidance to ent and catheters in vasular or other anatomical structures velocity color Dopler. Color Doppler can be combined with any imaging mode M-Mode includes anatomical M-Mode, and color M-Mode.

All items marked "P" were previously cleared in 510(k) K071134.

Arqui M. Wray

(Division Sic nductive Division of R ladiologic 510(k) Number

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

## Table 4.3- 9 Diagnostic Ultrasound Indications for Use Form -- HFL50x/15-6 Transducer

| System: | | SonoSite Maxx™ Series Ultrasound System | | | | | |
|----------------------------------------------------|---|---------------------------------------------------------------------------------------|-----|-----|------------------|---------------------|------------------|
| Transducer: | | HFL50x/15-6 MHz Transducer | | | | | |
| Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Small Organ (breast, thyroid, testicles, prostate) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1 |
| Other (spec.) | | | | | | | |

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

### Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Dopler, 3-D/4-D imaging, SonoRes/SonoHD imaging, r in a connuction polyner connect books on the maging, issue name in and processorial integrig
Sonole corpoint insune number in and popel maging, strain maging guidance for estina other alleying took only magniti, translang, magnig gudanes ne phock on pockers
ing of spint ont by one block processors, inaging produces of bases in to pacement of M-Mode Includes anatomical M-Mode, and color M-Mode.

All items marked "P" were previously cleared in 510{k) K071134.

Prescription Use (Per 21 CFR 801.109)

Jorge M. Wong

(Divisio Divisio Aadle 510(k) Nu

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

K082098

### Table 4.3- 10 Diagnostic Ultrasound Indications for Use Form – ICTx/8-5 Transducer

| System: | SonoSite Maxx™ Series Ultrasound System | | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|-------------------|---------------------|------------------|--|
| Transducer: | ICTx/8-5 MHz Transducer | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the<br>human body as follows: | | | | |…