SONOSITE MAXX SERIES ULTRASOUND SYSTEM

• K Number: K130173
• Device Name: SONOSITE MAXX SERIES ULTRASOUND SYSTEM
• Manufacturer: FUJIFILM SONOSITE,INC.
• Date Cleared: 2013-03-25 ( 60 days)
• Product Code: IYN ITX IYO LLZ
• Regulation Number: 892.1550

Intended Use

The SonoSite Maxx™ Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.

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 a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power.

Predicate Devices

K082098, K101757, K113156, K112953

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound image processing techniques (noise reduction, compounding) but does not mention AI, ML, deep learning, or any related concepts. There is no information about training or test sets, which are typical for AI/ML-based devices.

Therapeutic

No
The device is described as a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data," indicating its purpose is for imaging and evaluation, not treatment.

Diagnostic

Yes
Explanation: The "Device Description" explicitly states that the SonoSite Maxx Series Ultrasound System is a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "full featured, general purpose, software controlled, diagnostic ultrasound system" and mentions operating on battery or AC power, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is a "general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body." This describes a device used for in vivo (within the living body) imaging and analysis, not in vitro (outside the living body) testing of biological samples.
• Device Description: The description reinforces that it's a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data." This is consistent with in vivo imaging.
• Anatomical Site: The listed anatomical sites are all parts of the human body being imaged directly.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are hallmarks of IVD devices.

Therefore, the SonoSite Maxx™ Series Ultrasound System is a diagnostic imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonoSite Maxx™ Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.

Product codes

90-IYN, 90-IYO, 90-ITX, LLZ

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 a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel

Indicated Patient Age Range

Pediatric, Neonatal, Adult

Intended User / Care Setting

qualified physician

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

Not Found

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

Not Found

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

The SonoSite Maxx Series Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence.

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

Not Found

Predicate Device(s)

K082098, K101757, K113156, K112953

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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K!30173
Page 1 of 9

510(K) Summary

MAR 2 5 2013

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:

FUJIFILM SonoSite, Inc. 21919 30" Drive SE Bothell, WA 98021-3904

Corresponding Official:	Scott Paulson
	Manager, Regulatory Affairs
E-mail:	[e-mail]
Telephone:	[phone]
Facsimile:	[phone]
Date prepared:	December 21, 2012

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

Proprietarv 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	LLZ

3} Identification of the predicate or legally marketed device:

FUJIFILM SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx™ Series Ultrasound System (K082098, K101757), the SonoSite Edge Ultrasound System (K113156), the Terason t3000 Ultrasound System (K112953).

1

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 a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power.

5) Intended Use:

The SonoSite Maxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel

2

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| Feature | SonoSite Maxx Series
Ultrasound System
(This Submission) | SonoSite Maxx Series
Ultrasound System
(K082098, K101757) | SonoSite Edge™ Ultrasound
System
(K113156) | Terason T3000 Ultrasound
System
(K112953) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | | | |
| Indications for
Use | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs and vascular)
Intra-operative (Neuro.)
Pediatric
Small Organ (breast, thyroid, testicle, prostate) | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicle, prostate) | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicle, prostate) | Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicle, prostate) |
| | Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac) | Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac) | Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac) | Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric |
| | Peripheral Vessel
Biopsy guidance
Needle guidance | Peripheral Vessel
Biopsy guidance
Needle guidance | Peripheral Vessel
Biopsy guidance
Needle guidance | Peripheral Vessel
Biopsy guidance
Needle guidance |
| Transducer
Types | Linear Array
Curved Linear Array
Intracavitary | Linear Array
Curved Linear Array
Intracavitary | Linear Array
Curved Linear Array
Intracavitary | Linear Array
Curved Linear Array |

3

| Feature | SonoSite Maxx Series
Ultrasound System
(This Submission) | SonoSite Maxx Series
Ultrasound System
(K082098, K101757) | SonoSite Edge™ Ultrasound
System
(K113156) | Terason T3000 Ultrasound
System
(K112953) |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Transducer
Frequency | 1.0-15.0 MHz | 1.0-15.0 MHz | 1.0-15.0 MHz | Unknown |
| | Phased Array
Static Probes
Trans-esophageal | Phased Array
Static Probes
Trans-esophageal
Wobbler Probes | Phased Array
Static Probes
Trans-esophageal | Phased Array
Endocavitary
Microconvex |
| Modes of
Operation | B-mode Grayscale Imaging
3D/4D Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Anatomical M-Mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes | B-mode Grayscale Imaging
3D/4D Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Anatomical M-Mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes | 2D/B-Mode
M-Mode
Power Doppler
Directional Power Doppler
Color Doppler
Pulsed Wave Spectral Doppler
Continuous Wave Spectral Doppler
Duplex Doppler (Simultaneous, Real-Time 2-D and Spectral Doppler Display)
Triplex Display (Simultaneous, Real-Time 2-D, Color Doppler and Spectral Doppler Display)
ECG trace |
| PW Doppler | Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler | Available |
| CW Doppler | Continuous Wave (CW) Doppler | Continuous Wave (CW) Doppler | Continuous Wave (CW) Doppler | Available |
| | SonoRes/SonoHD Noise Reduction
SonoMB Image Compounding
Steered CW Doppler
Velocity Color Doppler
Color TDI | SonoRes/SonoHD Noise Reduction
SonoMB Image Compounding
Steered CW Doppler
Velocity Color Doppler
Color TDI | SonoHD2 Noise Reduction
SonoMB/MBe Image Compounding
Steered CW Doppler
Velocity Color Doppler
Color TOI | |
| Velocity Color
Doppler | Available | Available | Available | Unknown |
| Elastography
(Strain), and
Strain Rate
Imaging | Available | Available | Available | Unknown |
| ECG Feature | Available | Available | Available | Available |
| DICOM | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Feature | SonoSite Maxx Series
Ultrasound System
(This Submission) | SonoSite Maxx Series
Ultrasound System
(K082098, K101757) | SonoSite Edge™ Ultrasound
System
(K113156) | Terason T3000 Ultrasound
System
(K112953) |
| IMT
Measurement | SonoCalc IMT provides the capability for
automated measurement of intima-
media thickness (IMT) of the carotid
artery. | SonoCalc IMT provides the capability for
automated measurement of intima-
media thickness (IMT) of the carotid
artery. | SonoCalc IMT provides the capability for
automated measurement of intima-
media thickness (IMT) of the carotid
artery. | Unknown |
| #Transmit
Channels | 128 digital channels | 128 digital channels | 128 digital channels | Unknown |
| #Receive
Channels | 128 digital channels (using SA) | 128 digital channels (using SA) | 128 digital channels (using SA) | Unknown |
| Patient Contact
Materials | Transducers:
Acrylonitrile-butadien-styrene (ABS)
Cycoloy
Dow Medical Adhesive, Type A
Epoxy paste adhesive,
Polysulfone
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone Rubber
Urethane

Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene (ABS) | Transducers:
Acrylonitrile-butadien-styrene (ABS)
Cycoloy
Dow Medical Adhesive, Type A
Epoxy paste adhesive,
Polysulfone
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone Rubber
Urethane

Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene (ABS) | Transducers:
Acrylonitrile-butadien-styrene (ABS)
Cycoloy
Dow Medical Adhesive, Type A
Epoxy paste adhesive,
Polysulfone
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone Rubber
Urethane

Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene (ABS) | Transducers (10VSS only):
Polycarbonate
Silicon Rubber
Poly-Vinyl-Chloride (PVC) |
| System
Characteristics | M Series:
Beamformer 128/128 using SA
(configurable)
Hand held display and control
Single 10.4" Liquid Crystal Display (LCD)
256 gray shades on LCD

Dimensions: 10.9"(W) x 11.8 (L) x 3.0"(H) | M Series:
Beamformer 128/128 using SA
(configurable)
Hand held display and control
Single 10.4" Liquid Crystal Display (LCD)
256 gray shades on LCD

Dimensions: 10.9"(W) x 11.8 (L) x 3.0"(H) | Edge:
Beamformer 128/128 using SA
(configurable)
Hand held display and control
Single 12.1" Liquid Crystal Display (LCD)
256 gray shades on LCD

Dimensions: 12.9"(W) x 12.4 (L) x 2.5" (H) | T3000

15.4" (diagonal) TFTLED backlit hi-res
widescreen display
Anti-glare screen
Adjustable brightness

Dimensions:14.35 x 9.82 x 2.25" |
| | Weight: 8.3 lbs
Battery operated (1.5 - 4 hour operation
per charge)

100 - 240V options, 50/60 Hz | Weight: 8.3 lbs
Battery operated (1.5 - 4 hour operation
per charge)

100 - 240V options, 50/60 Hz | Weight: 8.5 lbs
Battery operated (1.5 - 4 hour operation
per charge)

100 - 240V options, 50/60 Hz, 15VDC
output | Weight:10.5lbs/4.8kg

RechargeableLithium-lonbatteryor
ACpower |
| | Various obstetrical, cardiac, volume, M- | Various obstetrical, cardiac, volume, M- | | Universal medical-gradepower supply
Inputvoltage: 100to240 V AC |
| Feature | SonoSite Maxx Series
Ultrasound System
(This Submission) | SonoSite Maxx Series
Ultrasound System
(K082098, K101757) | SonoSite Edge™ Ultrasound
System
(K113156) | Terason T3000 Ultrasound
System
(K112953) |
| | mode, PW and CW Doppler
measurement and calculation packages

ECG acquisition and display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio and image
storage on removable media
Measurement on Recalled Images.

Wireless 802.11 (a\b\g) support for
image transfer and Bluetooth® 2.0. for
voice activated remote control. | mode, PW and CW Doppler
measurement and calculation packages

ECG acquisition and display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio and image
storage on removable media
Measurement on Recalled Images.

Wireless 802.11 (a\b\g) support for
image transfer and Bluetooth® 2.0. for
voice activated remote control. | Various obstetrical, cardiac, volume, M-
mode, PW and CW Doppler
measurement and calculation packages

ECG acquisition and display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio and image
storage on removable media

Wireless 802.11 (a\b\g) support for
image transfer | Frequency:50to60 Hz

Preset-specific caliper measurements
and annotations
User-configurable measurements and
annotations

Electronicbeam steering
OmniBeam™
TeraVision™ II
Split-screendualdisplay
Simultaneous2D/Color
Trapezoidal imaging |
| | S Series:
Beamformer 128/128 using SA
(configurable)
Hand held display and control
Single 10.4" Liquid Crystal Display (LCD)
256 gray shades on LCD

Dimensions: 11.5"(W) x 14.8 (L) x 2.8"(H)

Weight: 8.5 lbs
Battery operated (1.5 - 4 hour operation
per charge) | S Series:
Beamformer 128/128 using SA
(configurable)
Hand held display and control
Single 10.4" Liquid Crystal Display (LCD)
256 gray shades on LCD

Dimensions: 11.5"(W) x 14.8 (L) x 2.8"(H)

Weight: 8.5 lbs
Battery operated (1.5 - 4 hour operation
per charge) | Various obstetrical, cardiac, volume, and
M-mode measurement and calculation
packages

ECG acquisition and display capabilities
Image storage on removable media
Measurement on recalled images

Wireless 802.11 (a\b\g) support for
image transfer and Bluetooth® 2.0 for
voice activated remote control | |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Track 3 |

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7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The SonoSite Maxx Series Ultrasound System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to all applicable mandatory medical device safety standards. The Maxx Series system also complies with voluntary standards which are detailed in Table 1.1-2 of this premarket submission. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. All patient contact materials are biocompatible. Reports for these elements of product development are referenced in Attachment 6.

Summary of Clinical Tests:

The SonoSite Maxx Series Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence.

The SonoSite Maxx Series Ultrasound System is designed to comply with the following' standards.

Reference No.	Title
AAMI/ANSI/ISO 10993-1	ISO 10993-1:2003(E), Biological evaluation of medical devices - Part 1: Evaluation
and testing
AAMI/ANSI/ISO 10993-5	ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In
Vitro cytotoxicity
AAMI/ANSI/ISO 10993-12	ISO 10993-12:2007, Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials
AAMI/ANSI/ISO 10993-10	ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed-type hypersensitivity
AAMI/ANSI/ISO 10993-11	ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11: Tests for
systemic toxicity.
IEC 60601-1	IEC 60601-1:1988, Medical Electrical Equipment - Part 1: General Requirements
for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
IEC 60601-1-1	IEC 60601-1-1:2000, Medical electrical equipment - Part 1-1: General requirements
for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2	IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests (Edition 3)
IEC 60601-1-4	IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4:
General requirements for safety -- Collateral standard: Programmable electrical
medical systems, edition 1.1

FDA Consensus Standards

7

| IEC 60601-2-37 | IEC 60601-2-37:2001, Particular Requirements for the Safety of Ultrasonic
Medical Diagnostic and Monitoring Equipment |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
| NEMA UD 3-2004 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine |
| AAMI/ANSI EC53 | AAMI / ANSI EC53:1995/(R) 2008, ECG cables and leadwires |
| AIUM MUS | AIUM MUS, Medical Ultrasound Safety |
| ISO /FDIS 15223-1 | Medical devices - Symbols to be used with medical device labels, labelling, and
information to be supplied - Part 1: General requirements |

.

Miscellaneous Standards

通

Reference No.	Title
Title 21 CFR Part 820	Quality System Regulation - Medical Devices: Current Good Manufacturing Practice (CGMP); Final Rule
ISO 9001	ISO 9001:2008, Quality management systems -- Requirements International Organization for Standardization
ISO 13485	ISO 13485:2003, Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management to medical devices
RTCA D160E	Radio Technical Commission for Aeronautics: Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy
CAN/CSA C22.2	CAN/CSA C22.2, No. 60601-1, Canadian Standards Association, Medical Electrical Equipment-Part 1. General Requirements for Safety
EN 60529	Degrees of protection provided by enclosures (IP Code) (1992)
UL 94	Underwriters Laboratories, Inc., Tests for Flammability of Plastic Materials for Parts in Devices and Appliances, 5th Edition
CISPR 11	International Electrotechnical Commission, International Special Committee on Radio Interference. Industrial, Scientific, and Medical (ISM) Equipment - Radio-Frequency Disturbance Characteristics-Limits and Methods of Measurement. Classification for the ultrasound system, docking system, accessories, and peripherals when configured together: Group 1, Class A.
NEMA PS 3.15	Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. 118
HIPAA	The Health Insurance and Portability and Accountability Act, Pub.L. No. 104-191
HIPAA	45 CFR 160, General Administrative Requirements
HIPAA	45 CFR 164, Security and Privacy

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K130173
Page 9 of 9

8) Conclusion:

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The product development process conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable electro medical 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 FUJIFILM SonoSite, Inc. that the SonoSite Maxx™ Series Ultrasound System is substantially equivalent with regard to safety and effectiveness to other devices already cleared for market.

9

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2013

FujiFilm SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 24th Street NW BUFFALO MN 55313

Re: K130173

Trade/Device Name: SonoSite Maxx™ Series Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, LLZ Dated: March 12, 2013 Received: March 13, 2013

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 Maxx166 Series Ultrasound System as described in your premarket notification:

Transducer Model Number P11x/10-5 HFL38x/13-6 P10x/8-4 L38xi/10-5 HFL50x/15-6 P21x/5-1 C8x/8-5 ICTx/8-5 SLAx/13-6 C11x/8-5 L25x/13-6 TEEx/8-3 D2x/2 L38x/10-5

L52x/10-5

C60x/5-2

10

Page 2 - Mr. Mark Job

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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Mr. Joshua Nipper at [phone].

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosures

11

Indications for Use Form

510(k) Number (if known): TBD

Device Name: SonoSite Maxx™ Series Ultrasound System

Indications for Use:

The SonoSite Maxx™ Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) _ K130173

Page 1 of 1

12

Table 1.3- 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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD;
B+CD
Fetal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Abdominal	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Intra-operative (Abdominal
organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Pediatric	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Small Organ (breast, thyroid,
testicles, prostate)	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	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Trans-rectal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Trans-vaginal
Trans-urethral	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Trans-esoph. (non-Card.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Musculo-skel. (Superfic.)
Intra-luminal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Other (spec.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Cardiac Adult	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Trans-esophageal (card.)
Other (spec.)	P	P	P	P	P	B+M; B+PWD;
B+CWD; B+CD	Note 1
Peripheral vessel
Other (spec.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	P11x/10-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal organs
and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N			N	B+M; 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.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	N	N			N	B+M; B+CD	Note 1
Other (spec.)

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, 3-D/4-D imaging, SoneRes/SonoHD imaging, SonoMBIMBe compund imaging (TD), color TDI, elastography imaging, strain rate inaging, and imaging for guidance of biopsy. Color Doppler includes velocity color Doppler can be combined with any imaging to assist in the placement of needles and catheters in vascular or other and imaging guidance for peripheral neve block procedures. Includes imaging of spinal cord to provide guidance for central new block procedure archiving, communications and storage inchinality. M-Modes antomical M-Mode, and

All items marked "P" were previously cleared in 510(k) K082098.

13

Table 1.3- 2 Diagnostic Ultrasound Indications for Use Form – P11x/10-5 Transducer

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Dopler. M-Mode. SonoRes/SonoHD imaging for guidance of biopsy and imaging to assist in the placement of needler or other analomical structures. Color Doppler can be combined with any imaging mode, Can be used with disposable kit cleared with K113680.

14

Table 1.3-3 Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 Transducer

System:		SonoSite Maxx™ Series Ultrasound System
Transducer:		L38xi/10-5 MHz Transducer
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 Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal
Abdominal		P	P	P		P	B+M; B+PWD; B+CD	Note 1
Intra-operative (Abdominal organs and vascular)		P	P	P		P	B+M; B+PWD; B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric		P	P	P		P	B+M; B+PWD; B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)		P	P	P		P	B+M; B+PWD; 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; B+CD	Note 1
Musculo-skel. (Superfic.)		P	P	P		P	B+M; B+PWD; 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; B+CD	Note 1
Other (spec.)

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, iissue harmonic imaging, SonoRestSonoHD imaging, SonoMBMBa compound imaging, tissue Doppler imaging guidance for peripheral nerve block procedures, imaging of spinal cord to provide guidance for central nerve block procedures, imaging to guidance of biopsy and imaging to assist in the placement of needlers in vasular or other analorical structures. Color Doppler includes velocity can be combined with any imaging made. M-Made includes color M-Mode.

All items marked "P" were previously cleared in 510(k) K113156.

15

				Table 1.3-4 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
human body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Trans-vaginal	P	P	P		P	B+M; B+PWD;
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.)

Additional Comments:

Note 1: Other includes color power Dopder, combined B and color power Doppler, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMB compound imaging, tissue Dopter imaging, strain rate imaging, imaging, imaging for guidance of biopsy and inaging to assist in the placement of needles and cather annamical structures. Color Dopler includes velocity color Doppler. Odor Dopler can be combined
with any inaging mode. M-Mode includes and c

All items marked "P" were previously cleared in 510(k) K082098.

16

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	C11x/8-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	B+M; B+PWD;
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;
B+CWD; B+CD	Note 1
Small Organ (breast, thyroid, testicles, prostate)	P	P	P	P
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Adult Cephalic							2.
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;
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.)

Table 1.3-5 Diagnostic Ultrasound Indications for Use Form - C11x/8-5 Transducer

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

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, 3-D/4-D imaging, SonoRes'SonoHD imaging, SonoMB compound imaging, tissue Dopler inaging (TD), elastography imaging, imaging guidance for peripheral neve block procedures, inaging for guidance of biopsy and inae placement of needles in vasular or ther anamical structures. Color Dopler insute, and otor M-Mode, and otor M-Mode,

All items marked "P" were previously cleared in 510(k) K082098.

17

NALA 118 A MINITERALA ASSESSMENTIA 1110010
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
	human body as follows:
Clinical Application	Mode of Operation
	Color
Combined
Other
	B	M	PWD	CWD	Doppler	(Spec.)	(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				D
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-6 Diagnostic Ultrasound Indications for Use Form - D2x/2 Transducer

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

Additional Comments:

All items marked "P" were previously cleared in 510(k) K082098.

18

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	C60x/5-2 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
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;
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;
B+CD	Note 1
Other (spec.)

Table 1.3-7 Diagnostic Ultrasound Indications for Use Form - C60x/5-2 Transducer

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

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Dopler, 3-D/4-D imaging, SonaRes/SonoHD imaging, SonoMBMBe compound imaging (TD), elastography imaging, strain rate imaging, imaging, imaging guidance for peripheral nerve block procedures, imaging of spinal cod to provide guidal neve block procedures, imaging for guidance of biopsy and imaging to assist in the placement of needes and cathelers in vascular or other anatomical structures. 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) K082098.

19

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	HFL38x/13-6 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Other (spec.)

Table 1.3-8 Diagnostic Ultrasound Indications for Use Form - HFL38x/13-6 Transducer

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

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMEIMBe compound imaging, tissue Dopter imaging (TD), elastography imaging, imaging guidance for peripheral neve block procedures, inaging of spinal cord to provide guital nerve block procedures, imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vasular or other analomical structures, Color Doppler Color Doppler Color Doppler Color Doppler Color Doppler can be contined with any imaging mode. M-Mode includes anatomical M-Mode, and color M-Mode.

All items marked "P" were previously cleared in 510(k) K082098.

20

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	HFL50x/15-6 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
						B+M; B+PWD;
Musculo-skel. (Convent.)	P	P	P		P	B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Other (spec.)

Table 1.3-9 Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 Transducer

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

Additional Comments:

Note 1: Other includes color power. combined B and color pover. 3-D4-D imaging, issue hamonic inaging, Sonces:Sonchly inaging, Sonces: procedures, imaging of spiral cord to provide guidal neve block procedures, imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other s. Color Doppler includes velocity 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 cloared in 510(k) K082098.

21

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	ICTx/8-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the
				human body as follows:
	Mode of Operation
Clinical Application
					Color	Combined	Other
	B	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
Ophthalmic
	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Fetal
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles. prostate)
Neonatal Cephalic
Adult Cephalic
						B+M; B+PWD;
Trans-rectal	P	D	P		P	B+CD	Note 1
						B+M; B+PWD;
Trans-vaginal	P	P	P		P	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.)

Table 1.3-10 Diagnostic Ultrasound Indications for Use Form – ICTx/8-5 Transducer

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

Additional Comments:

Note 1 Cther includes color power Dopler, combined B and color power Dopler, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMB compund imaging (TD), elastography imaging, strain rate imaging, imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other and ones. Color Doppler includes velocity 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) K082098.

22

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	L25x/13-6 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic		P	P			P	B+M; B+CD	Note 1
Fetal
Abdominal		P	P			P	B+M; B+CD	Note 1
Intra-operative (Abdominal organs and
vascular)		P	P			P	B+M; B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric		P	P			P	B+M; B+CWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)		P	P			P	B+M; B+CD	Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)		P	P			P	B+M; B+CD	Note 1
Musculo-skel. (Superfic.)		P	P			P	B+M; B+CD	Note 1
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel		P	P			P	B+M; B+CD	Note 1
Other (spec.)

Table 1.3-11 Diagnostic Ultrasound Indications for Use Form – L25x/13-6 Transducer

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

Additional Comments:

Note 1: Other includes color power Doppler, combined B and color power Doppler, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMBIMBe compound imaging (TD), elastography imaging, strain rate imaging, imaging guidance for peripheral nene block procedures, imaging for guidance of biopsy and inthe placement of needles and cathelers in vascular or ther anatomical structures. Color Doppler includes velocity color Doppler can be contined with any imaging mode. M-Mode includes anatomical M-Mode, and color M-Mode.

All items marked "P" were previously cleared in 510(k) K082098.

23

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	L38x/10-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Other (spec.)

Table 1.3-12 Diagnostic Ultrasound Indications for Use Form - L38x/10-5 Transducer

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

Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Dopler, 3-D/4-D imaging, SonoRes/SonoHD imaging. SonoMB compound imaging (issue Dopler imaging, strain rate imaging, imaging, imaging, imaging guidance for peripheral neve block procedures, imaging of spinal cor to rovide puber procedures, maing to guidace of biops; andinaging basissi in he drement in nedes
and cathers in vascular o the anatomical stuctures. Co

All items marked "P" were previously cleared in 510(k) K082098.

24

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	L52x/10-5 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Other (spec.)

Table 1.3-13 Diagnostic Ultrasound Indications for Use Form – L52x/10-5 Transducer

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

Additional Comments:

Note 1: Other includes color power Dopler. 3-D14-D imaging, tissue harmonic imaging, SonoRes(SonoHD imaging, SonoMB conpound imaging (TDI), elastography imaging, strain rate imaging, inaging lor guidance of biopsy and imaging to assis in the placement of needles and cather in vacular or other anatomical stuctures. 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) K082098.

25

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	P10x/8-4 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Fetal	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Abdominal	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Intra-operative (Neuro.)	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	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	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	Note 1
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; 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.)

Table 1.3-14 Diagnostic Ultrasound Indications for Use Form – P10x/8-4 Transducer

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

Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Dopler, 3-D/4-D imaging, tissue harmanic imaging, SonoRes/SonoHD imaging, SonoMB compond imaging (TD), color TDI, color TD. (Bastography imaging, imaging guidane fo peripheral neve Color Doppler includes velocity color Dopler 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) K082098.

26

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	P21x/5-1 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Fetal	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Abdominal	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	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	P	P	P		P	B+M; B+PWD; B+CD	Note 1
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD
B+CD	Note 1
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	Note 1
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; 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.)

Table 1.3-15 Diagnostic Ultrasound Indications for Use Form - P21x/5-1 Transducer
-----------------------------------------------------------------------------------	--

Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Dopler, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMB compound imaging (TDI), color TDI, elastography imaging, strain rate imaging, imaging, imaging in guidance of biopsy and imaging to assist in the placement of neasular or other analomical structures. Color Dopler includes velocity color Doppler. Color Doppler Color Doppler Color Doppler Color Dopp

Alf items marked "P" were previously cleared in 510(k) K082098.

27

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	SLAx/13-6 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Fetal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Abdominal	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Intra-operative (Neuro.)	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Laparoscopic	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Pediatric	P	P	P		P	B+M; B+PWD;
B+CD	Note 1
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD;
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;
B+CD	Note 1
Other (spec.)

Table 1.3-16 Diagnostic Ultrasound Indications for Use Form – SLAx/13-6 Transducer

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

Additional Comments:

Note 1: Other includes color power Dopler, 3-D4-D imaging, issue harmoric imaging, tissue harmoric imaging, SonoRes/SonoHD imaging, Sonte conporn inagng, issue Dopler inaging, imaging, imaging guidane o or oribras inversions inversions inversions investions investions in concerner ancours and color M-Moce

All items marked "P" were previously cleared in 510(k) K082098.

28

System:	SonoSite Maxx™ Series Ultrasound System
Transducer:	TEEx/8-3 MHz Transducer
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
Doppler	Combined
(Spec.)	Other
(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
Cardiac Pediatric
Trans-esophageal (card.)	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	Note 1
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-17 Diagnostic Ultrasound Indications for Use Form – TEEx/8-3 Transducer

viously cleared by FDA; E= added under this appendix

Additional Comments:

Note 1: Other includes color power Dopler, combined B and color power Dopler, 3-DV-D imaging, tissue harmonic imaging, SonoRes/SonoHD imaging, real minded one poper commer on the may in ate maging, insting, ingling, ingling, inglig, inglig, inglig, inglig, inglig, inglig, inglig
to assistinthe placenter in racular 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) K082098.

Prescription Use (Per 21 CFR 801.109)

Smh.p).

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) = K130173