The SonoSite NanoMaxx 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 and exam types include: Fetal/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Peripheral Vessel; Intra-operative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.

Device Description

The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, Color Power Doppler or in a combination of these modes. The hand-carried system weighs less than 6 pounds and has a touch screen interface with minimal controls to facilitate disinfection and cleaning. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system also includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images, which is used in conjunction with traditional risk assessment models to assess individual cardiovascular disease risk. The system includes security support to facilitate HIPAA compliance. The system includes a variety of accessories including a stand, dock featuring a video in/out port, a printer port, printer, VESA mounting arm and needle guide kits. The system includes two USB host supports for peripherals such as input devices and storage devices. Input devices include wired and wireless devices such as keyboard, and mouse. Storage devices include devices such as memory sticks, hard drives, and CDs. The system also features SiteLink™ allowing an additional method for the export of patient data. The System/Transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The System monitor displays the current output level in terms of the bioeffects indices ("Mechanical Index [MI]" and "Thermal Index [TI]") in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.

AI/ML Overview

The provided text is a 510(k) Summary for the SonoSite NanoMaxx™ Series Ultrasound System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed studies demonstrating novel performance against defined acceptance criteria. Therefore, the document does not contain explicit acceptance criteria or detailed study information of the type requested.

The document primarily focuses on:

Substantial Equivalence: Stating that the device is substantially equivalent to existing SonoSite Maxx Series Ultrasound Systems and Philips Medical Systems HDP 5000 Ultrasound System.
Device Description: A general overview of the SonoSite NanoMaxx system's features, modes of operation (2D, Doppler, Color Power Doppler), measurement capabilities, and compliance with various medical device standards.
Intended Use/Indications for Use: Listing the clinical applications for which the device is intended (e.g., Fetal/OB, Abdominal, Cardiac, Vascular, etc.) for the system as a whole and for specific transducers.
Technological Characteristics: Highlighting acoustic output limits and adherence to bioeffects indices standards.

Therefore, many sections of your requested output table cannot be filled from the provided text. The information below reflects what can be extracted.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from document)	Reported Device Performance (from document)
Acoustic Output Limits:	Met:
- ISPTA (d) Maximum: 720 mW/cm²	- ISPTA (d): 720 mW/cm² (Maximum)
- Tis/Tib/Tic Range: 0.0 - 4.0	- Tis/Tib/Tic: 0.0 - 4.0 (Range)
- Mechanical Index (MI) Maximum: 1.9	- Mechanical Index (MI): 1.9 (Maximum)
- ISPPA (d) Range: 0 - 700 W/cm²	- ISPPA (d): 0 - 700 W/cm² (Range)
Compliance with Standards:	Met (Implicitly stated by compliance with standards): The system is designed to comply with a range of standards including: - AAMI/ANSI/ISO 10993 (Biological evaluation of medical devices)- IEC 60601-1 (General requirements for safety)- IEC 60601-2-37 (Safety of ultrasonic medical diagnostic and monitoring equipment)- NEMA UD 2-2004 (Acoustic Output Measurement Standard)- NEMA UD 3-2004 (Real-Time Display of Thermal and Mechanical Acoustic Output Indices, explicitly stating adherence to on-screen display feature)- ISO 9001:2008 (Quality management systems)- 21 CFR Part 820 (Quality System Regulation)- EN ISO 13485:2003 (Quality management systems for regulatory purposes)- EN ISO 14971:2000 (Application of risk management)- RTCA D160E (Emission of Radio Frequency Energy)
Intended Use: (as defined by FDA guidance documents and listed clinical applications; functional equivalence to predicate devices)	Met (Implicitly stated through substantial equivalence to predicate devices and listed indications): The device functions to "acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, Color Power Doppler or in a combination of these modes." It provides "measurement capabilities for anatomical structures and fetal biometry." The listed indications for use are extensive, covering: Fetal/OB, Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculo-skeletal (Conventional & Superficial), Cardiac (Adult & Pediatric), and Intra-operative (abdominal organs, vascular, spinal cord for nerve blocks).
Functional Equivalence: (to predicate devices, meaning it operates in the same way and produces similar diagnostic information capabilities)	Met (Explicitly stated): "This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D mages. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, velocity color) are the same as a combination of the predicate devices identified in item 3." It also claims the limits for acoustic output are "the same as predicate Track 3 devices."

Regarding a "study that proves the device meets the acceptance criteria":

For a 510(k) submission, the "study" is often a comparison to a predicate device, focusing on functional, technological, and safety equivalence rather than a new clinical trial demonstrating efficacy or performance against novel criteria. The document states:

"SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx Series Ultrasound System (K071134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224)."

This implies that the "proof" is based on demonstrating that the NanoMaxx system has the same technological characteristics, intended use, and similar performance to these legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The document itself does not describe a specific clinical performance study designed to test specific acceptance criteria on a patient cohort for the purpose of this 510(k). The "studies" primarily referenced are compliance with various engineering, safety, and quality standards.

Filling the additional information points:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a test set or clinical study with a specified sample size.
- The "study" here is essentially the comparison of technical specifications and intended uses to predicate devices.
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):
- Not applicable. No test set with ground truth established by experts is described for this 510(k) submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set adjudication is described.
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:
- No. This is a diagnostic ultrasound system, not an AI-assisted interpretation device. The document does not describe any MRMC study or AI components.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a diagnostic ultrasound system requiring a human operator to perform imaging and interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No specific ground truth establishment is described for performance evaluation beyond general functional equivalence to predicate devices and compliance with technical standards.
The sample size for the training set:
- Not applicable. This document is for a conventional ultrasound system and does not mention machine learning or AI models requiring a "training set."
How the ground truth for the training set was established:
- Not applicable. As above.

Summary

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KOS205Y

OCT - 2 2009

510(K) Summary of Safety and Effectiveness

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

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

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

Corresponding Official:	Daina L. Graham
	Vice President, Regulatory Affairs and Quality Assurance
E-mail:	Daina.Graham@sonosite.com
Telephone:	(425) 951-1275
Facsimile:	(425) 951-1201
Date prepared:	June 19, 2009

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

SonoSite NanoMaxx™ 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
Medical image communications device	892.2020	LMD

ldentification of the predicate or legally marketed device: 3)

SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx Series Ultrasound System (K071134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224).

4) Device Description:

The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time

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ultrasound data in 2D, Doppler, Color Power Doppler or in a combination of these modes. The hand-carried system weighs less than 6 pounds and has a touch screen interface with minimal controls to facilitate disinfection and cleaning.

The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system also includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images, which is used in conjunction with traditional risk assessment models to assess individual cardiovascular disease risk.

The system includes security support to facilitate HIPAA compliance.

The system includes a variety of accessories including a stand, dock featuring a video in/out port, a printer port, printer, VESA mounting arm and needle guide kits. The system includes two USB host supports for peripherals such as input devices and storage devices. Input devices include wired and wireless devices such as keyboard, and mouse. Storage devices include devices such as memory sticks, hard drives, and CDs. The system also features SiteLink™ allowing an additional method for the export of patient data.

The System/Transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The System monitor displays the current output level in terms of the bioeffects indices ("Mechanical Index [MI]" and "Thermal Index [T]]") in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.

Frequency Range:	1.0 - 13.0 MHz
Transducer Types:	Linear array	Phased array
	Curved array

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 10993-12	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	Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988
IEC 60601-2-37	Medical Electrical Equipment - Part 2-37; Particular requirements for the safety ofultrasonic medical diagnostic and monitoring equipment (2001)

FDA Consensus Standards

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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

Miscellaneous Standards

...

Reference No.	Title
ISO 9001:2008	Quality management systems - Requirements International Organization forStandardization (2008)
Title 21 CFR Part 820	Quality System Regulation - Medical Devices: Current Good Manufacturing Practice(CGMP); Final Rule
EN ISO 13485:2003	Medical devices - Quality management systems - Requirements for regulatorypurposes (2003)
EN ISO 14971:2000	Medical devices - Application of risk management to medical devices (2000)(ISO 14971:2000)
RTCA D160E	Radio Technical Commission for Aeronautics: Environmental Conditions and TestProcedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy

and the comments of the comments of the comments of

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5) Intended Use:

The intended uses of the SonoSite NanoMaxx Series Ultrasound System as defined by FDA quidance documents, are:

Peripheral vessel
Fetal - OB/GYN
Abdominal
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Cardiac
Pediatric
Small Organ
(breast, thyroid, testicles, prostate)

Typical examinations performed using the SonoSite NanoMaxx Series Ultrasound System are

Abdominal Imaging Applications

This system transmits ultrasound energy into the abdomen of patients using 2D, color Doppler (Color), color power Doppler (CPD) to obtain ultrasound images. The liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally.

Cardiac Imaging Applications

This system transmits ultrasound energy into the thorax of patients using 2D, to obtain ultrasound images. The heart, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heart size can be assessed for the presence of pathology.

Gynecology and Infertility Imaging Applications

This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, color Doppler, and color power Doppler (CPD) to obtain ultrasound images. The uterus, adnexa, and surrounding anatomical structures can be assessed for the presence of pathology transabdominally.

Interventional Imaging Applications

You can use the system for ultrasound guidance in drainage procedures, vascular line placement, peripheral nerve blocks, spinal nerve blocks and taps, amniccentesis and other obstetrical procedures, and provide assistance during abdominal, breast, and neurological surgery.

Obstetrical Imaging Applications

This system transmits uftrasound energy into the pelvis of pregnant women using 2D, color Doppler and color power Doppler (CPD) to obtain ultrasound images. The fetal anatomy, viability, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally. CPD imaging is intended for high-risk pregnant women. High-risk pregnancy indications include, but are not limited to, multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus.

Pediatric and Neonatal Imaging Applications

This system transmits ultrasound energy into the pediatric patients using 2D, color Doppler and color power Doppler (CPD) to obtain ultrasound images. The pediatric abdominal, pelvic, and surrounding anatomical structures can be assessed for the presence or absence of pathology.

Superficial Imaging Applications

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This system transmits ultrasound energy into various parts of the body using 2D, color Doppler and color power Doppler (CPD) to obtain ultrasound images. The breast, thyroid, testicle, iymph nodes, hernias, musculoskeletal structures, soft tissue structures, and surrounding anatomical structures can be assessed for the presence or absence of pathology. This system can be used to provide ultrasound guidance drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps.

Vascular Imaging Applications

This system transmits ultrasound energy into the various parts of the body using 2D, color Doppler and color power Doppler (CPD) to obtain ultrasound images. The carotid arteries, deep veins, and arteries in the arms and legs, superficial veins in the arms and legs, great vessels in the abdomen, and various small vessels feeding organs can be assessed for the presence or absence of pathology.

6) Technological Characteristics:

This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D mages. Dopler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, velocity color) are the same as a combination of the predicate devices identified in item 3. Transducer patient contact materials are biocompatible.

This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUMNEMA UD 3-2004) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.

ISPTA (d)	720 mW/cm²	Maximum
Tis/Tlb/Tlc	0.0 - 4.0	Range
Mechanical Index (MI)	1.9	Maximum
ISPPA (d)	0 - 700 W/cm²	Range

The device's acoustic output limits are:

The limits are the same as predicate Track 3 devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular fashion around the bird. The text is in all capital letters.

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

Sonosite, Incorporated % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

OCT = 2 2009

Re: K092058

Trade/Device Name: SonoSite NanoMaxx™ Series Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 7, 2009 Received: July 8, 2009

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 Elastography for SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C11n/8-5 C60n/5-2 L25n/13-6

L38n/10-5 P21n/5-1 Phased Array

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

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Page 2 - Mr. Mark Job

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 (OS) 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at (301) 796-6542.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known): # # K 092058

Device Name: NanoMaxx: SonoSite NanoMaxx™ Series Ultrasound System

Indications for Use:

Prescription Use: X (Part 21 CFR 801 Subpart D)

510(k) Number

AND/OR

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

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

Concurrence of CHRH, Office of Device Evaluation (ODE)

Concurrence of CHRP

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

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Table 1.3-1 Diagnostic Ultrasound Indications for Use Form - SonoSite NanoMaxx™ Series Ultrasound System

System:Transducer:Intended Use:Clinical Application
						Abdominal	N	N	B+CD, B+CPD	Note 1
						Intra-operative (Abdominal Organs,Vascular)	N	N	B+CD, B+CPD	Note 1
						Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	B+CD, B+CPD	Note 1
	Small Organ (Breast, Thyroid, Testicles,Prostate)	N	N	B+CD, B+CPD	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	B+CD, B+CPD	Note 1
	Musculo-skeletal (Superficial)	N	N	B+CD, B+CPD	Note 1
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult	N	N	B+CD, B+CPD	Note 1
	Cardiac Pediatric	N	N	B+CD, B+CPD	Note 1
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	B+CD, B+CPD	Note 1
	Other (Specify)

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

Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Dopler, and Color Velocity Imaging

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Dopler, Tissue Harmanic Imaging, SonoHD Compound Inaging, Tissue Dopler inaging. Color Dopler includes Color Dopler can be contined with any imaging note. Melutes inaging assist in the spinal cord to grovide guidance for central nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off, Division of Reproductive, Radiological De 510(k) Number

PAGE 53 of 1310

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System:Transducer:Intended Use:Clinical Application			SonoSite NanoMaxx™ Series Ultrasound System
			C11n/8-5 8.0-5.0 MHz Curved ArrayDiagnostic ultrasound imaging or fluid flow analysis of the human body as follows
			Mode of Operation
	General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N				N	B+CD, B+CPD	Note 1
	Intra-operative (Abdominal Organs,Vascular)	N				N	B+CD, B+CPD	Note 1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N				N	B+CD, B+CPD	Note 1
	Small Organ (Breast, Thyroid, Testicles,Prostate)	N				N
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N				N	B+CD, B+CPD	Note 1
	Other (Specify)

Table 1.3-2 Diagnostic Ultrasound Indications for Use Form - C11n/8-5 Transducer

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

Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Additional Comments:

Note 1: Other indudes Color Power Dopler, Sont Color Power SonolH Compund maging. Con Copper incluse
Color Velociy Dopler can be combined with any imaging mode. Includes i or other anatomical structures, and expanded intended use for peripheral nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

(Division S Division of eproductive, Abdomina Radiological Devices 510(k) Number

PAGE 54 of 1310

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System:			SonoSite NanoMaxx™ Series Ultrasound System
Transducer:		C60n/5-2 5.0-2.0 MHz Curved Array
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N				N	B+CD, B+CPD	Note 1
	Abdominal	N				N	B+CD, B+CPD	Note 1
	Intra-operative (Abdominal Organs,Vascular)	N				N	B+CD, B+CPD	Note 1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N				N	B+CD, B+CPD	Note 1
	Small Organ (Breast, Thyroid, Testicles,Prostate)	N				N	B+CD, B+CPD	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N				N	B+CD, B+CPD	Note 1
	Other (Specify)

Table 1.3-3 Diagnostic Ultrasound Indications for Use Form - C60n/5-2 Transducer

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

Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Additional Comments:

Note 1: Ober hokudes Color Power Dopler, Tissue Hamonic maging, Sonel Direction, Sonolf Dinajng, Sonola Compund imaging, placement of needles and cather in vascular or other analomical structures. Includes imaging of spinal cord to central nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

(Division Sign Off)

(Divisio Division of Reproductive. Abdom Radiological Devices 510(k) Number

PAGE 55 of 1310

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System:	SonoSite NanoMaxx™ Series Ultrasound System
Transducer:	L25n/13-6 13.0-6.0 MHz Linear Array
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application	Mode of Operation
	General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD CWD	ColorDoppler	Combined (Specify)	Other*(Specify)
	Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	Fetal
		Abdominal	N			N	B+CD, B+CPD	Note 1
		Intra-operative (Abdominal Organs,Vascular)	N			N	B+CD, B+CPD	Note 1
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric	N			N	B+CD, B+CPD	Note 1
		Small Organ (Breast, Thyroid, Testicles,Prostate)	N			N	B+CD, B+CPD	Note 1
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal (Conventional)	N			N	B+CD, B+CPD	Note 1
		Musculo-skeletal (Superficial)	N			N	B+CD, B+CPD	Note 1
		Intravascular
		Other (Specify)
	Cardiac	Cardiac Adult	N			N	B+CD, B+CPD	Note 1
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
		Other (Specify)
PeripheralVessel	Peripheral vessel	N			N	B+CD, B+CPD	Note 1
	Other (Specify)

Table 1.3-4 Diagnostic Ultrasound Indications for Use Form – L25n/13-6 Transducer

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

Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Additional Comments:

Note 1: Other includes Code Power Dopler, Sonol Coppler, Sonold Compund maging . Color Dopter includes Color
Velodiy Dopler . Cola Oopler can be combined with any imaging na structures and an expanded intended use for imaging guidance for peripheral nerve block procedures.

Prescription Use (Per 21 CFR 801.109)

(Divis Division of 510(k) Number

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

System:Transducer:Intended Use:Clinical Application		SonoSite NanoMaxx™ Series Ultrasound SystemL38n/10-5 10.05.0 MHz Linear Array TransducerDiagnostic ultrasound imaging or fluid flow analysis of the human body asfollows
								Abdominal	N	N	B+CD, B+CPD	Note 1
								Intra-operative (Abdominal Organs,Vascular)	N	N	B+CD, B+CPD	Note 1
									Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N		N	B+CD, B+CPD	Note 1
	Small Organ (Breast, Thyroid, Testicles,Prostate)	N		N	B+CD, B+CPD	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N		N	B+CD, B+CPD	Note 1
	Musculo-skeletal (Superficial)	N		N	B+CD, B+CPD	Note 1
	Intravascular
	Other (Specify)
	Cardiac	Cardiac Adult	N		N	B+CD, B+CPD	Note
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
PeripheralVessel	Peripheral vessel	N		N	B+CD, B+CPD	Note 1
	Other (Specify)

Table 1.3-5 Diagnostic Ultrasound Indications for Use Form - L38n/10-5 Transducer

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

Examples of other modes of operation may include Dopler, 3-D Imaging, Harmoric Imaging, Tlssue Molon Doppler, and Color Velocity Imaging

Additional Comments:

Note 1: Other includes Color Power Oopler, combined B and Color Power Dopler, SonoMB Compound Imaging. Coior Dopler includes Color Velocity Doppler. Color Dopler can be combined with any imaging to assist in the placement of needles and cathers in vascular of other anatomical stockues and imaging guidance for perioral neve block procedures. Includes imaging of spinal card to realiza neve block procedures.

Prescription Use (Per 21 CFR/801.109)

(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Device 510(k) Number

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System:		SonoSite NanoMaxx™ Series Ultrasound System
Transducer:		P21n/5-1 5.0-1.0 MHz Phased Array Transducer
Intended Use:Clinical Application		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Fetal Imaging &Other	Fetal		N	N	B+CD, B+CPD	Note 1
	Abdominal		N	N	B+CD, B+CPD	Note 1
	Intra-operative (Abdominal Organs,Vascular)		N	N	B+CD, B+CPD	Note 1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		N	N	B+CD, B+CPD	Note 1
	Small Organ (Breast, Thyroid, Testicles,Prostate)		N	N	B+CD, B+CPD	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult		N	N	B+CD, B+CPD	Note 1
	Cardiac Pediatric		N	N	B+CD, B+CPD	Note 1
	Intravascular (Cardiac)
	Trans-esoph. (Cardlac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		N	N	B+CD, B+CPD	Note 1
	Other (Specify)

Table 1.3-6 Diagnostic Ultrasound Indications for Use Form – P21n/5-1 Phased Array Transducer

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

Examples of other modes of operation may include Dopler, 3-D Inaging, Harmonic Imaging, Tissue Motion Dopler, and Color Velocity Imaging

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, Tissue Harmonic Inaging, SonoMB Compound Insuze, Tissue Doppler. Color Doppler includes Color Velocity Doppler can be combined with any imaging mode. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

Prescription Use (Per 21 CFR 801.109)

Heu Reem

(Division Bign-Off) Division of Reproductive, Abdom Radiological Devices 510(k) Number

PAGE 58 of 1310

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.