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
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K082098 , K101757 , K113156 , K112953
• Predicate For: K133454 , K140254 , K160734 , K172059 , K202160

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.

AI/ML Overview

The provided document is a 510(k) summary for the FUJIFILM SonoSite Maxx™ Series Ultrasound System and its associated transducers. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing novel clinical studies to establish new acceptance criteria. Therefore, the document primarily lists the features and performance of the device and compares them to the predicate devices, rather than defining specific acceptance criteria for performance metrics and studies to prove they are met.

Based on the document, here's the information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

The document does not define specific quantitative "acceptance criteria" for the device's imaging performance (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence by demonstrating that the device's technological characteristics, intended use, and indications for use are comparable to legally marketed predicate devices and that it complies with relevant safety and performance standards.

The "reported device performance" is implicitly that it performs equivalently to the predicate devices for the listed applications and modes. The tables provided (Table 1.3-1 to 1.3-17) list the clinical applications and modes of operation for the main system and each transducer. "P" indicates that these indications and modes were "previously cleared" for the predicate devices, which implies the current device meets existing performance expectations for these.

Feature/Metric	Acceptance Criteria (Implicitly met by Predicate Equivalence)	Reported Device Performance (Implicitly Equivalent to Predicate)
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body	Same as predicate devices (SonoSite Maxx™ Series Ultrasound System, SonoSite Edge Ultrasound System, Terason t3000 Ultrasound System)
Indications for Use (System)	Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-Rectal/Vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel, Biopsy/Needle guidance, etc.	Same as predicate devices, with some minor additions/modifications (e.g., this submission includes "Cardiac Adult" and "Trans-esophageal (cardiac)" for the main system, and specific transducer tables indicate which modes are available for each application, marked "P" for previously cleared in predicate K082098, K113156). Specific modes are B, M, PWD, CWD, Color Doppler, Combined.
Transducer Types	Linear Array, Curved Linear Array, Intracavitary	Same as most predicate devices (Terason T3000 only lists Linear and Curved Linear Array, but other SonoSite predicates include Intracavitary).
Transducer Frequency	1.0-15.0 MHz	Same as SonoSite Maxx Series (K082098, K101757) and SonoSite Edge Ultrasound System (K113156).
Modes of Operation	B-mode, 3D/4D, Tissue Harmonic, M-mode, Anatomical M-Mode, Color M-Mode, Color Power Doppler, Zoom, Combination Modes, PW Doppler, CW Doppler, SonoRes/SonoHD Noise Reduction, SonoMB Image Compounding, Steered CW Doppler, Velocity Color Doppler, Color TDI, Elastography, Strain Rate Imaging, ECG, DICOM (3.0), IMT Measurement	Same as SonoSite Maxx Series (K082098, K101757) and SonoSite Edge Ultrasound System (K113156), with the Terason t3000 having a slightly different set of named features.
Electrical, Thermal, Mechanical, EMC Safety	Conformance to applicable mandatory medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, etc.)	Found to conform to all applicable mandatory medical device safety standards.
Biocompatibility	Conformance to AAMI/ANSI/ISO 10993 series	All patient contact materials are biocompatible, conforming to AAMI/ANSI/ISO 10993 series.
Acoustic Output	Conformance to NEMA UD 2-2004, NEMA UD 3-2004, AIUM MUS	Evaluated and found to conform to these standards.
Quality System	Conformance to 21 CFR 820, ISO 9001, ISO 13485	Product development process conforms to these quality systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "The SonoSite Maxx Series Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." This means there was no specific "test set" of patient data used for clinical performance validation as would be the case for a new or significantly modified device. The data provenance is therefore not applicable in the context of clinical performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies were performed, there was no "test set" or explicit "ground truth" establishment by experts for performance metrics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical studies with test sets were performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical imaging device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical studies with specific performance endpoints requiring ground truth were performed. The "ground truth" for this 510(k) submission relies on demonstrating substantial equivalence to predicate devices that have an established history of safety and effectiveness, meaning their performance was already accepted by regulatory bodies.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device that requires a training set and ground truth for it.

In summary:

The submission for the SonoSite Maxx™ Series Ultrasound System is a 510(k) premarket notification. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. For such submissions, extensive new clinical performance studies are often not required if the device is sufficiently similar to existing ones.

In this case, the manufacturer has established substantial equivalence by:

• Comparing the Intended Use and Indications for Use of the new device and its transducers to those of predicate devices (K082098, K101757, K113156, K112953). The tables indicate that almost all applications and modes ("P" for previously cleared) are identical or highly similar to those cleared for the predicate devices.
• Detailing the Technological Characteristics (e.g., transducer types, frequency, modes of operation, system specifications) and showing they are equivalent to or improve upon predicate devices without introducing new safety or effectiveness concerns.
• Demonstrating compliance with a comprehensive list of national and international safety and performance standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, NEMA UD series for acoustic output). These standards define a baseline of acceptable performance and safety for such devices.
• Explicitly stating that clinical studies were not required, as the equivalence was demonstrated through non-clinical testing and comparison to predicates.

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).

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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

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Technological Characteri (9 Sonolite Max Seies Vitrasund System is Track Indamental scientife tembley a Max seritif technoleg a Max serit
and Edge Utrasound System is Trace Utrasond System is ubstantily OMA Access Systems LL

Feature	SonoSite Maxx SeriesUltrasound System(This Submission)	SonoSite Maxx SeriesUltrasound System(K082098, K101757)	SonoSite Edge™ UltrasoundSystem(K113156)	Terason T3000 UltrasoundSystem(K112953)
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body
Indications forUse	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organs and vascular)Intra-operative (Neuro.)PediatricSmall Organ (breast, thyroid, testicle, prostate)	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organs and vascular)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (breast, thyroid, testicle, prostate)	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organs and vascular)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (breast, thyroid, testicle, prostate)	Fetal - OB/GYNAbdominalIntraoperative (abdominal organs and vascular)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (breast, thyroid, testicle, prostate)
	Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)	Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)	Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)	Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac Pediatric
	Peripheral VesselBiopsy guidanceNeedle guidance	Peripheral VesselBiopsy guidanceNeedle guidance	Peripheral VesselBiopsy guidanceNeedle guidance	Peripheral VesselBiopsy guidanceNeedle guidance
TransducerTypes	Linear ArrayCurved Linear ArrayIntracavitary	Linear ArrayCurved Linear ArrayIntracavitary	Linear ArrayCurved Linear ArrayIntracavitary	Linear ArrayCurved Linear Array

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Feature	SonoSite Maxx SeriesUltrasound System(This Submission)	SonoSite Maxx SeriesUltrasound System(K082098, K101757)	SonoSite Edge™ UltrasoundSystem(K113156)	Terason T3000 UltrasoundSystem(K112953)
TransducerFrequency	1.0-15.0 MHz	1.0-15.0 MHz	1.0-15.0 MHz	Unknown
	Phased ArrayStatic ProbesTrans-esophageal	Phased ArrayStatic ProbesTrans-esophagealWobbler Probes	Phased ArrayStatic ProbesTrans-esophageal	Phased ArrayEndocavitaryMicroconvex
Modes ofOperation	B-mode Grayscale Imaging3D/4D Grayscale ImagingTissue Harmonic ImagingM-modeAnatomical M-ModeColor M-ModeColor Power DopplerZoomCombination Modes	B-mode Grayscale Imaging3D/4D Grayscale ImagingTissue Harmonic ImagingM-modeAnatomical M-ModeColor M-ModeColor Power DopplerZoomCombination Modes	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination Modes	2D/B-ModeM-ModePower DopplerDirectional Power DopplerColor DopplerPulsed Wave Spectral DopplerContinuous Wave Spectral DopplerDuplex 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 ReductionSonoMB Image CompoundingSteered CW DopplerVelocity Color DopplerColor TDI	SonoRes/SonoHD Noise ReductionSonoMB Image CompoundingSteered CW DopplerVelocity Color DopplerColor TDI	SonoHD2 Noise ReductionSonoMB/MBe Image CompoundingSteered CW DopplerVelocity Color DopplerColor TOI
Velocity ColorDoppler	Available	Available	Available	Unknown
Elastography(Strain), andStrain RateImaging	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 SeriesUltrasound System(This Submission)	SonoSite Maxx SeriesUltrasound System(K082098, K101757)	SonoSite Edge™ UltrasoundSystem(K113156)	Terason T3000 UltrasoundSystem(K112953)
IMTMeasurement	SonoCalc IMT provides the capability forautomated measurement of intima-media thickness (IMT) of the carotidartery.	SonoCalc IMT provides the capability forautomated measurement of intima-media thickness (IMT) of the carotidartery.	SonoCalc IMT provides the capability forautomated measurement of intima-media thickness (IMT) of the carotidartery.	Unknown
#TransmitChannels	128 digital channels	128 digital channels	128 digital channels	Unknown
#ReceiveChannels	128 digital channels (using SA)	128 digital channels (using SA)	128 digital channels (using SA)	Unknown
Patient ContactMaterials	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive, Type AEpoxy paste adhesive,PolysulfonePolyurethanePoly-Vinyl-Chloride (PVC)Silicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive, Type AEpoxy paste adhesive,PolysulfonePolyurethanePoly-Vinyl-Chloride (PVC)Silicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive, Type AEpoxy paste adhesive,PolysulfonePolyurethanePoly-Vinyl-Chloride (PVC)Silicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Transducers (10VSS only):PolycarbonateSilicon RubberPoly-Vinyl-Chloride (PVC)
SystemCharacteristics	M Series:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 10.4" Liquid Crystal Display (LCD)256 gray shades on LCDDimensions: 10.9"(W) x 11.8 (L) x 3.0"(H)	M Series:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 10.4" Liquid Crystal Display (LCD)256 gray shades on LCDDimensions: 10.9"(W) x 11.8 (L) x 3.0"(H)	Edge:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 12.1" Liquid Crystal Display (LCD)256 gray shades on LCDDimensions: 12.9"(W) x 12.4 (L) x 2.5" (H)	T300015.4" (diagonal) TFTLED backlit hi-reswidescreen displayAnti-glare screenAdjustable brightnessDimensions:14.35 x 9.82 x 2.25"
	Weight: 8.3 lbsBattery operated (1.5 - 4 hour operationper charge)100 - 240V options, 50/60 Hz	Weight: 8.3 lbsBattery operated (1.5 - 4 hour operationper charge)100 - 240V options, 50/60 Hz	Weight: 8.5 lbsBattery operated (1.5 - 4 hour operationper charge)100 - 240V options, 50/60 Hz, 15VDCoutput	Weight:10.5lbs/4.8kgRechargeableLithium-lonbatteryorACpower
	Various obstetrical, cardiac, volume, M-	Various obstetrical, cardiac, volume, M-		Universal medical-gradepower supplyInputvoltage: 100to240 V AC
Feature	SonoSite Maxx SeriesUltrasound System(This Submission)	SonoSite Maxx SeriesUltrasound System(K082098, K101757)	SonoSite Edge™ UltrasoundSystem(K113156)	Terason T3000 UltrasoundSystem(K112953)
	mode, PW and CW Dopplermeasurement and calculation packagesECG acquisition and display capabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaMeasurement on Recalled Images.Wireless 802.11 (a\b\g) support forimage transfer and Bluetooth® 2.0. forvoice activated remote control.	mode, PW and CW Dopplermeasurement and calculation packagesECG acquisition and display capabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaMeasurement on Recalled Images.Wireless 802.11 (a\b\g) support forimage transfer and Bluetooth® 2.0. forvoice activated remote control.	Various obstetrical, cardiac, volume, M-mode, PW and CW Dopplermeasurement and calculation packagesECG acquisition and display capabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaWireless 802.11 (a\b\g) support forimage transfer	Frequency:50to60 HzPreset-specific caliper measurementsand annotationsUser-configurable measurements andannotationsElectronicbeam steeringOmniBeam™TeraVision™ IISplit-screendualdisplaySimultaneous2D/ColorTrapezoidal imaging
	S Series:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 10.4" Liquid Crystal Display (LCD)256 gray shades on LCDDimensions: 11.5"(W) x 14.8 (L) x 2.8"(H)Weight: 8.5 lbsBattery operated (1.5 - 4 hour operationper charge)	S Series:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 10.4" Liquid Crystal Display (LCD)256 gray shades on LCDDimensions: 11.5"(W) x 14.8 (L) x 2.8"(H)Weight: 8.5 lbsBattery operated (1.5 - 4 hour operationper charge)	Various obstetrical, cardiac, volume, andM-mode measurement and calculationpackagesECG acquisition and display capabilitiesImage storage on removable mediaMeasurement on recalled imagesWireless 802.11 (a\b\g) support forimage transfer and Bluetooth® 2.0 forvoice 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: Evaluationand testing
AAMI/ANSI/ISO 10993-5	ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for InVitro cytotoxicity
AAMI/ANSI/ISO 10993-12	ISO 10993-12:2007, Biological evaluation of medical devices - Part 12: Samplepreparation and reference materials
AAMI/ANSI/ISO 10993-10	ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests forirritation and delayed-type hypersensitivity
AAMI/ANSI/ISO 10993-11	ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11: Tests forsystemic toxicity.
IEC 60601-1	IEC 60601-1:1988, Medical Electrical Equipment - Part 1: General Requirementsfor 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 requirementsfor 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 requirementsfor basic safety and essential performance - Collateral standard: Electromagneticcompatibility - 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 electricalmedical systems, edition 1.1

FDA Consensus Standards

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IEC 60601-2-37	IEC 60601-2-37:2001, Particular Requirements for the Safety of UltrasonicMedical 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 Indiceson 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, andinformation 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.

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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

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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	ColorDoppler	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 (Abdominalorgans 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-vaginalTrans-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 vesselOther (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 humanbody as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal organsand 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 thehuman body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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	ColorDoppler	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
	ColorCombinedOther
	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 thehuman body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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 thehuman body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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 thehuman body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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
FetalAbdominal
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 thehuman body as follows:
Clinical Application		Mode of Operation
		B	M	PWD	CWD	ColorDoppler	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 andvascular)		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 thehuman body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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 thehuman body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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	ColorDoppler	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+PWDB+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+PWDB+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+PWDB+CD	Note 1
Neonatal Cephalic	P	P	P		P	B+M; B+PWDB+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+PWDB+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 thehuman body as follows:
Clinical Application .	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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+PWDB+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+PWDB+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+PWDB+CD	Note 1
Neonatal Cephalic	P	P	P		P	B+M; B+PWDB+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+PWDB+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 thehuman body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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 thehuman body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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

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.