Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound system with various imaging modes, measurement capabilities, and data handling features. There is no mention of AI, ML, or any features that would typically indicate the use of such technologies for image analysis, diagnosis, or workflow optimization beyond standard digital processing.

Therapeutic

No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" system, indicating its use for diagnostic purposes, not therapeutic intervention.

Diagnostic

Yes.
The "Intended Use / Indications for Use" states "Diagnostic ultrasound imaging or fluid flow analysis of the human body," and the "Device Description" mentions "The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-carried ultrasound system" and mentions hardware components like transducers, ECG cable assembly, and a main system control panel. While it is "software controlled," it is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The SonoSite hand-carried ultrasound system (C2 Series) is an ultrasound imaging system. It uses sound waves to create images of internal structures within the human body (in vivo).
Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This is an in vivo diagnostic procedure.
Device Description: The description details the system's capabilities for acquiring and displaying real-time ultrasound data, performing measurements on anatomical structures, and supporting various imaging modes. These are all functions related to in vivo imaging.

The device is a diagnostic imaging device, but it does not perform in vitro testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended uses of the SonoSite hand-carried ultrasound system (C2 Series). as defined by FDA quidance documents, are:

Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles.)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel

Typical examinations performed using the SonoSite hand-carried ultrasound system (C2 Series) are:

Abdominal Imaging Applications:
This system transmits ultrasound energy into the abdomen of patients using 2D, M-mode, color power Doppler (CPD), directional color power Doppler (DCPD), velocity color Doppler (VCD), Tissue Harmonic Imaging (THI), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler 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, M-mode, directional color power Doppler (DCPD), velocity color Doppler (VCD), color Doppler, Tissue Harmonic Imaging (THI), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler 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 or absence of pathology. The heart can be imaged transthoracic. The patient's electrocardiogram (ECG) may be obtained and is used for accurate timing of diastolic and systolic function.

Cephalic Imaging Applications:
This system transmits ultrasound energy into the heads of adults and neonates using 2D, M-mode, color power Doppler (CPD), directional color power Doppler (DCPD), velocity color Doppler (VCD), and pulsed wave (PW) Doppler to obtain ultrasound images. The patient's blood flow can be evaluated transcranially.

Gynecology and Infertility Imaging Applications:
This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, Mmode, color power Doppler (CPD), directional color power Doppler (DCPD), velocity color Doppler (VCD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The uterus, ovaries, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaqinally.

Interventional and Intraoperative Imaging Applications:
This system transmit ultrasound energy into the various parts of the body using 2D. color power Doppler (CPD), directional color power Doppler (DCPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images that provide guidance during interventional and intraoperative procedures. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance during abdominal and vascular intraoperative procedures.

Obstetrical Imaging Applications:
This system transmits ultrasound energy into the pelvis of pregnant women using 2D, M-mode, color power Doppler (CPD), directional color power (DCPD), velocity color Doppler (VCD), color Doppler, Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding anatomical structures can be assessed for the presence or absence of pathology trans-abdominally or transvaginally. CPD and DCPD 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,

Warning: CPD or DCPD images can be used as an adjunctive method, not as a screening tool for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation (IUGR).

Pediatric and Neonatal Imaging Applications:
This system transmits ultrasound energy into the pediatric or neonatal patients using 2D, M-mode, color power Doppler (CPD), directional color power Doppler (DCPD), velocity color Doppler (VCD), pulsed wave (PW) and continuous wave (CW) Doppler to obtain ultrasound images. The pediatric abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal heads, and surrounding anatomical structures can be assessed for the presence or absence of pathology.

Prostate Imaging Applications:
This system transmits ultrasound energy into the prostate of an adult male using 2D, Mmode, color power Doppler (CPD), velocity color Doppler (VCD), and pulsed wave (PW) Doppler to obtain ultrasound images. The prostate gland can be assessed for the presence or absence of pathology transrectally.

Superficial Imaging Applications:
This system transmits ultrasound energy into various parts of the body using 2D. M-mode, color power Doppler (CPD), velocity color Doppler (VCD), and pulsed wave (PW) Doppler to obtain ultrasound images. The breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, and surrounding anatomical structures can be assessed for the presence or absence of pathology.

Vascular Imaging Applications:
This system transmits ultrasound energy into the various parts of the body using 2D, Mmode, color power Doppler (CPD), velocity color Doppler (VCD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The carotid arteries, deep veins 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Product codes (comma separated list FDA assigned to the subject device)

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

Device Description

The SonoSite hand-carried ultrasound system, C2 Series is a highly portable, software controlled ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler (VCD) and Directional Color Power Doppler, or in a combination of these modes.

The System has an electrocardiography (ECG) display feature and supports a 3lead ECG cable assembly to collect data for M-mode measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The system includes Digital Imaging and Communications (DICOM) to capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images.

The SonoSite hand-carried ultrasound system (C2 Series) is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.

Frequency Range: 2.0 - 10.0 MHz
Transducer Types: Linear array, Curved array, Intracavitary array, Static probes

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intra-operative (Abdominal organs and vascular), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac (Adult, Pediatric), Peripheral vessel, Thorax, Heads (adults and neonates), Pelvis, Prostate, Limbs/Arms/Legs.

Indicated Patient Age Range

Adult, Pediatric, Neonatal. Fetal.

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K014116, K010374, K011224

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

K023957

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:	Michael A. Hoffman
	Director – Quality Assurance and Regulatory Affairs
E-mail:	michael.hoffman@sonosite.com
Telephone:	(425) 951-1297
Facsimile:	(425) 951-1201
Date prepared:	November 13, 2002

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

Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

SonoSite hand-carried ultrasound system (C2 Series) (subject to change)

Classification Names

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

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 hand-carried ultrasound system (K014116), (K010374) and the Philips Ultrasound HDI® 5000 Ultrasound System (K011224). Where applicable, this new Submission references sections of K014116 and K010374 to signify that the sections remain the same as for those predicate devices.

1

Device Description: 4)

The SonoSite hand-carried ultrasound system, C2 Series is a highly portable, software controlled ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler (VCD) and Directional Color Power Doppler, or in a combination of these modes.

The System has an electrocardiography (ECG) display feature and supports a 3lead ECG cable assembly to collect data for M-mode measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The system includes Digital Imaging and Communications (DICOM) to capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images.

The SonoSite hand-carried ultrasound system (C2 Series) is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.

Frequency Range:	2.0 - 10.0 MHz
Transducer Types:	Linear array
	Curved array
	Intracavitary array
	Static probes

The SonoSite hand-carried ultrasound system (C2 Series) is designed to comply with the standards listed below.

a. ANSI/AAMI EC 53: 1995 + Amendments, ECG Cables and Electrodes except for sections 4.4 and 4.5.9.
b. CAN/CSA-C22.2, No. 601.1:1998, Canadian Standards Association, Medical Electrical Equipment-Part 1. General Requirements for Safety
c. EN 60529. European Norm, Degrees of Protection Provided by Enclosures (I.P. Code)
d. EN 60601-1:1997. European Norm, Medical Electrical Equipment-Part 1. General Requirements for Safety
e. EN 60601-1-1:1993, European Norm, Medical Electrical Equipment Part 1. General Requirements for Safety-Section 1-1. Collateral Standard. Safety Requirements for Medical Electrical Systems

2

EN 60601-1-2:2001. European Norm. Medical Electrical Equipment. General f. Requirements for Safety-Collateral Standard. Electromagnetic Compatibility. Requirements and Tests, Second Edition
g. EN 60601-2-25:1996, European Norm, Medical Electrical Equipment-Part 2. ` Particular Requirements for Safety-Section 25. Specification for Electrocardiographs
h. IEC 61157:1992, International Electrotechnical Commission, Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
ISO 10993 Biological Evaluation of Medical Devices and Related Tests ...:
i. JIS-T-100x Series, Japanese Standards for Medical Electrical Equipment
Medical Ultrasound Safety, American Institute of Ultrasound in Medicine k. (AIUM), 1994
NEMA PS3.15 2000, Digital Imaging and Communications in Medicine ﺎ . (DICOM) Part 15: Security Profile.
m. NEMA UD2-1998. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
n. NEMA UD3-1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
o. RTCA/DO160D:1997, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B
p. UL 2601-1:1999, Underwriters Laboratories, Inc., Medical Electrical Equipment-Part 1: General Requirements for Safety
q. UL 94, Fifth Edition, Underwriters Laboratory, Inc., Tests for Flammability of Plastic Materials for Parts in Devices and Appliances

5) Intended Use:

The intended uses of the SonoSite hand-carried ultrasound system (C2 Series). as defined by FDA quidance documents, are:

Fetal - OB/GYN	Trans-rectal
Abdominal	Trans-vaginal
Intra-operative	Trans-urethral
(Abdominal organs and vascular)
Laparoscopic	Musculo-skel. (Conventional)
Pediatric	Musculo-skel. (Superficial)
Small Organ	Cardiac Adult
(breast, thyroid, testicles.)
Neonatal Cephalic	Cardiac Pediatric
Adult Cephalic	Peripheral vessel

3

Typical examinations performed using the SonoSite hand-carried ultrasound system (C2 Series) are:

Abdominal Imaqinq Applications:

This system transmits ultrasound energy into the abdomen of patients using 2D, M-mode, color power Doppler (CPD), directional color power Doppler (DCPD), velocity color Doppler (VCD), Tissue Harmonic Imaging (THI), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler 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, M-mode, directional color power Doppler (DCPD), velocity color Doppler (VCD), color Doppler, Tissue Harmonic Imaging (THI), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler 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 or absence of pathology. The heart can be imaged transthoracic. The patient's electrocardiogram (ECG) may be obtained and is used for accurate timing of diastolic and systolic function.

The ECG is not used to diagnose cardiac arrhythmias and is not designed for Warning: long term cardiac rhythm monitoring.

Cephalic Imaging Applications:

This system transmits ultrasound energy into the heads of adults and neonates using 2D, M-mode, color power Doppler (CPD), directional color power Doppler (DCPD), velocity color Doppler (VCD), and pulsed wave (PW) Doppler to obtain ultrasound images. The patient's blood flow can be evaluated transcranially.

Gynecology and Infertility Imaging Applications:

This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, Mmode, color power Doppler (CPD), directional color power Doppler (DCPD), velocity color Doppler (VCD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The uterus, ovaries, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaqinally.

Interventional and Intraoperative Imaging Applications:

This system transmit ultrasound energy into the various parts of the body using 2D. color power Doppler (CPD), directional color power Doppler (DCPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images that provide guidance during interventional and intraoperative procedures. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance during abdominal and vascular intraoperative procedures,

4

Obstetrical Imaging Applications:

This system transmits ultrasound energy into the pelvis of pregnant women using 2D, M-mode, color power Doppler (CPD), directional color power (DCPD), velocity color Doppler (VCD), color Doppler, Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding anatomical structures can be assessed for the presence or absence of pathology trans-abdominally or transvaginally. CPD and DCPD 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,

| Warning: | CPD or DCPD images can be used as an adjunctive method, not as a screening tool
for the detection of structural anomalies of the fetal heart and as an adjunctive
method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation
(IUGR). |

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

Pediatric and Neonatal Imaging Applications:

This system transmits ultrasound energy into the pediatric or neonatal patients using 2D, M-mode, color power Doppler (CPD), directional color power Doppler (DCPD), velocity color Doppler (VCD), pulsed wave (PW) and continuous wave (CW) Doppler to obtain ultrasound images. The pediatric abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal heads, and surrounding anatomical structures can be assessed for the presence or absence of pathology.

Prostate Imaging Applications:

This system transmits ultrasound energy into the prostate of an adult male using 2D, Mmode, color power Doppler (CPD), velocity color Doppler (VCD), and pulsed wave (PW) Doppler to obtain ultrasound images. The prostate gland can be assessed for the presence or absence of pathology transrectally.

Superficial Imaging Applications:

This system transmits ultrasound energy into various parts of the body using 2D. M-mode, color power Doppler (CPD), velocity color Doppler (VCD), and pulsed wave (PW) Doppler to obtain ultrasound images. The breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, and surrounding anatomical structures can be assessed for the presence or absence of pathology.

Vascular Imaging Applications:

This system transmits ultrasound energy into the various parts of the body using 2D, Mmode, color power Doppler (CPD), velocity color Doppler (VCD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The carotid arteries, deep veins 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.

5

Technological Characteristics: 6)

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 or Mmode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, CW Doppler, velocity color Doppler, Color Power Doppler, and directional color power Doppler, and duplex imaging) 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 (AIUM/NEMA. 1998) 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.

The device's acoustic output limits are:

All applications:

ISPTA (d)	720 mW/cm² (Maximum)
TIS/TIB/TIC	0.1 - 4.0 (Range)
Mechanical Index (MI)	1.9 (Maximum)
ISPPA (d)	0 - 700 W/cm² (Range)

The limits are the same as predicate Track 3 devices.

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 13 2002

SonoSite, Inc. % Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K023957

Trade Name: SonoSite Hand-carried Ultrasound System (C2 Series) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO. and ITX Dated: November 26, 2002 Received: November 27, 2002

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 Hand-carried Ultrasound System, as described in your premarket notification:

Transducer Model Number

C11/7-4 7.0-4.0 MHz Curved Array C11e/10-5 10.0-5.0 MHz Curved Array

7

C15/4-2 4.0-2.0 MHz Curved Array C60/5-2 5.0-2.0 MHz Curved Array HST/10-5 10.0-5.0 MHz Linear Array ICT/7-4 7.0-4.0 MHz Intracavitary C8/8-5 8.0-5.0 MHz Prostate ICTe/10-5 10.0 -5.0 MHz Intracavitary L25/10-5 10.0-5.0 MHz Linear Array L38/10-5 10.0-5.0 MHz Intracavitary . L52/10-5 and L52S/10-5 10.0-5.0 MHz Linear Array 2.0 MHz Dual Element Circular 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

8

Page 3 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket " notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Lor

Sincerely yours,

Third St. Lynn

Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure(s)

9

K04 395 7

D02345B - C2 510(k) submission 13-Nov-2002, Pg. 29 of 587

System:	SonoSite hand-carried ultrasound system, version C2
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows::
Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Abdominal
Intra-operative
(Abdominal organs and
vascular)	P	P	P	P	N	B+M; B+PWD;
B+CWD;
B+CD	Note 1
Fetal Imaging	Intra-operative (Neuro.)
Laparoscopic	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
							B+M; B+PWD;
B+CWD;
B+CD
& Other	Pediatric
Small Organ (breast,
thyroid, testicles.)	P	P	P	P	N	B+M; B+PWD;
B+CD	Note 1
							B+M; B+PWD;
B+CWD;
	Neonatal Cephalic	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Adult Cephalic	N	N	N		N	B+M;
B+PWD;
B+CD	Note 1
	Trans-rectal	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Trans-vaginal
Trans-urethral	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P			B+M; B+PWD	Note 1
	Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1

	Cardiac Adult	P	P	P	P	N	B+M; B+PWD;
B+CWD;
B+CD	Note 1
Cardiac	Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)	P	P	P	P	N	B+M; B+PWD;
B+CWD;
B+CD	Note 1


Peripheral
Vessel	Peripheral vessel
Other (spec.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1

Table 1- Diagnostic Ultrasound Indications for Use Form - C2 System

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(K) K014116. Included with this 510k inveging to assist in the placement of needles and catheters in vascular or other anatomical structures.

Color Doppler includes Velocity Color Doppler.

Prescription Use (Per 21 CFR 801.109)

David G. Watson
(Division Sign-Off)

Indications for Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023957
S

Section 4.3

10

Table 2 - Diagnostic Ultrasound Indications for Use For

System:			SonoSite hand-carried ultrasound system, version C2
Transducer:			C11/7-4 7.0 - 4.0 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 I only)		Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic		Ophthalmic
		Fetal
		Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic	P	P	P	P	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
Fetal Imaging
& Other		Pediatric
Small Organ (breast,
thyroid, testicles.)	P	P	P	P	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
		Neonatal Cephalic	P	P	P	P	N	B+M; B+PWD;
B+CD	Note 1
		Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac		Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)	P	P	P	P	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
Peripheral
Vessel		Peripheral vessel
Other (spec.)	P	P	P	P	N	B+M; B+PWD;
B+CD	Note 1

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D rroso in other mades over refror a pridance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

Color Doppler includes Velocity Color Doppler.

David A. Segegm

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

11

K023757

D02345B - C2 510(k) submission 13-Nov-2002, Pg. 31 of 587

Table 3 - Diagnostic Ultrasound Indications for Use Form - C11e/10-5 Transducer
---------------------------------------------------------------------------------

System:	SonoSite hand-carried ultrasound system, version C2
Transducer:		C11e/10-5 10.0 - 5.0 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 I only)		Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic		Ophthalmic
		Fetal
		Abdominal	N	N	N	N	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
		Intra-operative (Abdominal
organs and vascular)
		Intra-operative (Neuro.)
Fetal Imaging		Laparoscopic
& Other		Pediatric
Small Organ (breast,
thyroid, testicles.)	N	N	N	N	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
		Neonatal Cephalic	N	N	N	N	N	B+M; B+PWD;
B+CD	Note 1
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skel. (Convent.)
		Musculo-skel. (Superfic.)
		Intra-luminal
		Other (spec.)
		Cardiac Adult
Cardiac		Cardiac Pediatric	N	N	N	N	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
		Trans-esophageal (card.)
		Other (spec.)
Peripheral
Vessel		Peripheral vessel	N	N	N	N	N	B+M; B+PWD;
B+CD	Note 1
		Other (spec.)

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

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Coior Power Doppier, combined B and Diet Power Doppler, Co Note 1: Other Includes Color Power Depler over Depple, Combition of any office of a filter his only of the Michiel Octor of Pine Housed With this 16. Included with this new imaging, Tissue Tramonic maging, and maging for gridation of breasular or other anatomical structures.

Color Doppler includes Velocity Color Doppler.

Ehrind G. Slayman

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

12

K023957

e 4 - Diagnostic Ultrasound Indications for Use Form - C15/4-2 Tr

System:		SonoSite hand-carried ultrasound system, version C2
Transducer:		C15/4-2 4.0 - 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 I only)		Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined.
(Spec.)	Other
(Spec.)
Ophthalmic		Ophthalmic
		Fetal	P	P	P			B+M; B+PWD	Note 1
		Abdominal	P	P	P	P	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
		Intra-operative (Abdominal
organs and vascular)	P	P	P			B+M; B+PWD	Note 1
Fetal Imaging
& Other		Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P			B+M; B+PWD	Note 1
		Small Organ (breast,
thyroid, testicles.)	P	P	P			B+M; B+PWD	Note 1
		Neonatal Cephalic	P	P	P			B+M; B+PWD	Note 1
		Adult Cephalic	N	N	N		N	B+M; B+PWD;
B+CD	Note 1
		Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
		Musculo-skel. (Convent.)	P	P	P			B+M; B+PWD	Note 1
Cardiac		Cardiac Adult	P	P	P	P	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
		Cardiac Pediatric	P	P	P	P	N	B+M; B+PWD;
B+CWD; B+CD	Note 1
		Trans-esophageal (card.)
Other (spec.)							Note 1
		Peripheral vessel	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
Peripheral
Vessel		Other (spec.)

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

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harnonic Imaging for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needies and catheters in vascular or other analorrical structures. Color Doppler includes Velocity Color Doppler.

David G. Legnon

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number .

13

System:		SonoSite hand-carried ultrasound system, version C2
Transducer:		C60/5-2 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 I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Abdominal	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Intra-operative (Abdominal
organs and vascular)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Intra-operative (Neuro.)
Laparoscopic
Fetal Imaging
	Pediatric	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
& Other	Small Organ (breast,
thyroid, testicles.)
	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	P	P		N	B+M; B+PWD;
B+CD	Note 1
Cardiac	Cardiac Pediatric
Trans-esophageal (card.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

Table 5 - Diagnostic Ultrasound Indications for Use Form - C60/5-2 Transducer

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

Color Doppler includes Velocity Color Doppler.

Daniel A. Logemann

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number .

14

K03 3.4.5.7

			Table 6 - Diagnostic Ultrasound Indications for Use Form - HST/10-5 Transducer

System:			SonoSite hand-carried ultrasound system, version C2
Transducer:			HST/10-5 10.0-5.0 MHz Linear Array Transducer
Intended Use:			Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:


		Clinical Application		Mode of Operation
General
(Track I only)		Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic		Ophthalmic
		Fetal
		Abdominal
		Intra-operative (Abdominal
organs and vascular)	E	E	E		N	B+M; B+PWD;
B+CD	Note 1
		Intra-operative (Neuro.)
Fetal Imaging		Laparoscopic
								B+M; B+PWD;
B+CD
& Other		Pediatric	E	E	E		N	B+M; B+PWD;
B+CD	Note 1
		Small Organ (breast,
thyroid, testicles.)	E	E	E		N	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.)	E	E	E			B+M; B+PWD;
B+CD	Note 1
		Musculo-skel. (Superfic.)	E	E	E		N	B+M; B+PWD;
B+CD	Note 1
		Intra-luminal
		Other (spec.)

		Cardiac Adult
Cardiac		Cardiac Pediatric
		Trans-esophageal (card.)
Other (spec.)

Peripheral
Vessel		Peripheral vessel
Other (spec.)	E	E	E		N	B+M; B+PWD;
B+CD	Note 1

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

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, combined B and Directional Color Power Dopler, 3-D Imaging, Tissue Harnonic Imaging for guidance of biopsy previously cleared through 510(K) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Color Doppler includes Velocity Color Doppler.

David C. Bohrman

(Division Sign-Off) Division of Reproductive, Abdom ം i Radiological Devices ്(k) Number _________________________________________________________________________________________________________________________________________________________________

15

K023457.

Table 7 - Diagnostic Ultrasound Indications for Use Form - ICT/7-4 Transdu

| Clinical Application | | | Mode of Operation | | | | | Other
(Spec.) | |
|---------------------------|----------------------------------------------------|--|-------------------|---|-----|-----|------------------|---------------------|---------------------|
| General
(Track I only) | Specific
(Tracks I & III) | | B | M | PWD | CWD | Color
Doppler | | Combined
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | P | P | P | | N | B+M; B+PWD;
B+CD | Note 1. |
| | Abdominal | | | | | | | | |
| | Intra-operative (Abdominal
organs and vascular) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast,
thyroid, testicles.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | P | P | P | | N | B+M; B+PWD;
B+CD | Note 1 |
| | Trans-vaginal | | P | P | P | | N | 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 | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |

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

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(K) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Color Doppler includes Velocity Color Doppler.

David C. Leyman

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _

16

K04 3757

System:	SonoSite hand-carried ultrasound system, version C2
Transducer:	C8/8-5 8.0- 5.0 MHz Prostate Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as
follows:
Clinical Application
Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	B+M; B+PWD;
B+CD	Note 1
	Abdominal
	Intra-operative (Abdominal
organs and vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
Pediatric
	Small Organ (breast,
thyroid, testicles.)
	Neonatal Cephalic
Adult Cephalic
	Trans-rectal	N	N	N		N	B+M; B+PWD;
B+CD	Note 1
	Trans-vaginal	N	N	N		N	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	Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral
Vessel	Peripheral vessel
Other (spec.)

Diagnostic Ultrasound Indications for Use Form - C8/8-5

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

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

Color Doppler includes Velocity Color Doppler.

Daniel G. Legrain

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

17

KLB 3951

			Table 9 - Diagnostic Ultrasound Indications for Use Form - ICTe/10-5 Transduce

		Mode of Operation
System:	SonoSite hand-carried ultrasound system, version C2
Transducer:	ICTe/10-5 10.0- 5.0 MHz Intracavitary Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as
follows:
	Clinical Application

	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
General
(Track I only)
Ophthalmic	Ophthalmic
							B+M; B+PWD;
B+CD	Note 1
	Fetal	N	N	N	N	N	B+M; B+PWD;
B+CD	Note 1
	Abdominal
	Intra-operative (Abdominal
organs and vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
Small Organ (breast,
thyroid, testicles.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	B+M; B+PWD;
B+CD	Note 1
	Trans-vaginal	N	N	N	N	N	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k ine imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Color Doppler includes Velocity Color Doppler.

Color Doppler includes Velocity Color Doppler

Quist G. Legman

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

18

K023957

		Clinical Application			Mode of Operation
System:	SonoSite hand-carried ultrasound system, version C2
Transducer:	L25/10-5 10.0-5.0 MHz Linear Array
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
		General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
	Ophthalmic	Ophthalmic
			Fetal	P	P	P			B+M; B+PWD	Note 1
			Abdominal	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
			Intra-operative (Abdominal
organs and vascular)	P	P	P			B+M; B+PWD	Note 1
Fetal Imaging			Intra-operative (Neuro.)
Laparoscopic	P	P	P			B+M; B+PWD	Note 1
& Other			Pediatric
Small Organ (breast,
thyroid, testicles.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
			Neonatal Cephalic
Adult Cephalic	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
			Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P			B+M; B+PWD	Note 1
			Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
Cardiac			Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
Peripheral			Peripheral vessel
Other (spec.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1

Table 10 - Diagnostic Ultrasound Indications for Use Form – L25/10-5 Transduc

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

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D rround in Stree Harmonic Inc. Depirer just be of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Color Doppler includes Velocity Color Doppler.

Color Doppler includes velocity Color Doppler

David K. Sezman

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

19

| SonoSite hand-carried ultrasound system, version C2

System:
Transducer:	L38/10-5 10.0- 5.0 MHz Intracavitary Transducer
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P			B+M; B+PWD	Note 1
	Abdominal
Intra-operative (Abdominal
organs and vascular)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic	P	P	P			B+M; B+PWD	Note 1
& Other	Pediatric
Small Organ (breast,
thyroid, testicles.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Neonatal Cephalic	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P			B+M; B+PWD	Note 1
	Musculo-skel. (Superfic.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
	Intra-luminal
	Other (spec.)
Cardiac Adult
Cardiac	Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
Peripheral
Vessel	Peripheral vessel
Other (spec.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1

Table 11 - Diagnostic Ultrasound Indications for Use Form - L38/10-5 Transo

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

Additional Comments:

Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Color Doppler includes Velocity Color Doppler.

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 5 10(k) Number _

20

KD23957

Table 12 - Diagnostic Ultrasound Indications for Use Form -- L52/10-5 & L52-S/10-5 Transducers

Clinical Application			Mode of Operation
General
(Track I only)		Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic		Ophthalmic
		Fetal	P	P	P			B+M; B+PWD	Note 1
		Abdominal	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
		Intra-operative (Abdominal
organs and vascular)	P	P	P			B+M; B+PWD	Note 1
		Intra-operative (Neuro.)
Laparoscopic	P	P	P			B+M; B+PWD	Note 1
Fetal Imaging
& Other		Pediatric	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
		Small Organ (breast,
thyroid, testicles.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
		Neonatal Cephalic
Adult Cephalic	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
		Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P			B+M; B+PWD	Note 1
		Musculo-skel. (Superfic.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
		Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac		Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1
Peripheral
Vessel		Peripheral vessel
Other (spec.)	P	P	P		N	B+M; B+PWD;
B+CD	Note 1

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(K) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

Color Doppler includes Velocity Color Doppler.

David A. Legum

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

21

K 023957

.

System:	SonoSite hand-carried ultrasound system, version C2
Transducer:		Doppler Pencil Transducer 2.0 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
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Abdominal
organs and vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (breast,
thyroid, testicles.)
	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	Cardiac Adult				N
	Cardiac Pediatric				N
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

Table 13 - Diagnostic Ultrasound Indications for Use Form - 2 MHz Doppler Pencil

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

Daniel A. Lehman

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