(16 days)
No
The document describes standard ultrasound imaging capabilities and measurements, including automated IMT measurement, but does not mention AI, ML, or related technologies.
No
The 'Intended Use / Indications for Use' section clearly states that the device is for "Diagnostic ultrasound imaging or fluid flow analysis", and the 'Device Description' reiterates its purpose as a "diagnostic ultrasound system". There is no mention of therapeutic applications.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" calls it a "diagnostic ultrasound system" and states that it provides "information used for clinical diagnostic purposes."
No
The device description explicitly states it is a "full featured, general purpose, software controlled, diagnostic ultrasound system" and mentions accepting "curved or linear transducers." This indicates it includes hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this is a diagnostic ultrasound system. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging and fluid flow analysis of the human body, not the analysis of biological samples.
Therefore, the SonoSite High-Resolution Ultrasound System (C3 Series) is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended uses of the SonoSite High-Resolution Ultrasound System (C3 Series) as defined by FDA guidance documents, are:
Fetal - OB/GYN
Abdominal (Abdominal organs and vascular)
Intra-operative (Neuro.)
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
Trans-esophageal (card.)
Peripheral vessel
Typical examinations performed using the SonoSite High-Resolution Ultrasound System (C3 Series) are:
Abdominal Imaging Applications
Cardiac Imaging Applications
Gynecology and Infertility Imaging Applications
Interventional and Intraoperative Imaging Applications
Obstetrical Imaging Applications
Pediatric and Neonatal Imaging Applications
Prostate Imaging Applications
Superficial Imaging Applications
Vascular Imaging Applications
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The SonoSite High-Resolution Ultrasound System (C3 Series) is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes.
The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler 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 the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.
The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.
The SonoSite High-Resolution Ultrasound System (C3 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, cardiac, pelvis, lower abdomen, various parts of the body, prostate, breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, carotid arteries, deep veins, superficial veins, great vessels, fetal anatomy, fetal heart.
Indicated Patient Age Range
Fetal, pediatric, neonatal, adult.
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.
K030949, K011224, K011188, K020353
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.
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
§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for SonoSite. The logo consists of a stylized, curved shape above the word "SonoSite." The curved shape is black and appears to be a stylized wave or arc. The word "SonoSite" is in a bold, sans-serif font, with a small trademark symbol to the right of the word.
JAN 1 2 2005
SonoSite, Inc.
21919 30ᵗʰ Drive SE
Bothell, WA 98021-3904 USA
Telephone:1.425.951.1200
Facsimile:1.425.951.1201
510(K) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1) Submitter's name, address, telephone number, contact person:
SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
| 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: | December 9, 2004 |
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 High-Resolution Ultrasound System (C3 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 |
Identification of the predicate or legally marketed device: 3)
SonoSite, Inc. believes that the System described in this Substantially equivalent to a combination of the SonoSite TITAN™ Ultrasound System (K030949), Philips Ultrasound HD1 5000 Ultrasound System (K011224), the GE LOGIQ 9 Diagnostic Ultrasound System (K011188) and the Siemens OMNIA X/XS Diagnostic Ultrasound System (K020353).
1
4) Device Description:
The SonoSite High-Resolution Ultrasound System (C3 Series) is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes.
The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler 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 the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.
The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.
The SonoSite High-Resolution Ultrasound System (C3 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 - 12.0 MHz |
|---|---|
| Transducer Types: | Linear array |
| Curved array | |
| Intracavitary array | |
| Phased array | |
| Static probes |
The SonoSite High-Resolution Ultrasound System (C3 Series) is designed to comply with the standards listed below.
| Reference no. | Title |
|---|---|
| EN 540 | Clinical investigation of medical devices for human subjects (1993) |
| EN 980 A1 | Graphical symbols for use in the labeling of medical devices (2003) |
| EN 1041 | Information supplied by the manufacturer with medical devices (1998) |
| EN ISO 13485 | Medical devices - Quality management systems - Requirements for regulatory purposes (2003) |
| EN ISO 14971 | Medical devices - Application of risk management to medical devices (2000) (ISO 14971:2000) (Superseded standard: EN 1441) |
| EN ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing (1997) (ISO 10993-1:1997) |
| EN 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988 |
| EN 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988 |
| Reference no. | Title |
| Amendment A1 | 1:1988/A1:1991 |
| EN 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601- |
| Amendment A2 | 1:1988/A2:1995 + corrigendum June 1995 |
| EN 60601-1-1 | Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (2001) (IEC 601-1-1:2001) |
| EN 60601-1-2 | Medical electrical equipment - Part 1: General requirements for safety; 2. collateral standard: electromagnetic compatibility; requirements and tests (2001) (IEC 60601-1-2:2001) |
| EN 60601-2-37 | Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (2001) (IEC 60601-2-37:2001) |
| Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994 | |
| Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1993 | |
| Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1998 | |
| ANSI/AAMI | |
| EC53:1995 | ECG Cables and Electrodes except for sections 4.4 and 4.5.9 |
| ASTM D5276-98 | Standard Test Methods for Drop Test of Loaded Containers by Free Fall |
| ASTM D999-96 | Standard Methods for Vibration Testing of Shipping Containers |
| CEI/IEC 61157:1992 | International Electrotechnical Commission, Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment |
| D00017 | Quality System Manual (SonoSite) |
| EN 60529 | Degrees of protection provided by enclosures (IP Code) (1991 |
| ISO 9001: 1994 | Quality Systems - Model for quality assurance in design, development, production, installation and servicing |
| JIS T 0601-1 | Medical Electrical Equipment - Part 1: General Requirements for Safety (Japan) (1999) |
| JIS T 1507 | Electronic Linear Scanning Ultrasonic Diagnostic Equipment (Japan) (1989) |
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
| NEMA UD 3-2004 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine |
| 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 |
| Title 21 CFR Part 820 | Quality System Regulation - Medical Devices: Current Good Manufacturing Practice (CGMP); Final Rule |
| UL 60601-1 | Underwriters Laboratories, Medical Electrical Equipment-Part 1: General Requirements for Safety (2003) |
| ACR-NEMA DICOM | |
| version 3.0 - 2003 | Digital Imaging and Communications in Medicine |
510(K) Summary Of Safety And Effectiveness
Page 2 of 6
2
3
5) Intended Use:
The intended uses of the SonoSite High-Resolution Ultrasound System (C3 Series) as defined by FDA guidance documents, are:
| Fetal - OB/GYN | Trans-rectal |
|---|---|
| Abdominal | Trans-vaginal |
| Intra-operative | |
| (Abdominal organs and vascular) | Trans-urethral |
| Intra-operative (Neuro.) | Musculo-skel. (Conventional) |
| Laparoscopic | Musculo-skel. (Superficial) |
| Pediatric | Cardiac Adult |
| Small Organ | |
| (breast, thyroid, testicles.) | Cardiac Pediatric |
| Neonatal Cephalic | Trans-esophageal (card.) |
| Adult Cephalic | Peripheral vessel |
Typical examinations performed using the SonoSite High-Resolution Ultrasound System (C3 Series) are:
Abdominal Imaging Applications
This system transmits ultrasound energy into the abdomen of patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) 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, color Doppler (Color), Tissue Harmonic Imaging (THI), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler to obtain ultrasound images. The heart muscle, cardiac valves, great vessels, and surrounding anatomical structures can be assessed for, overall cardiac performance, size, fluid, and the presence or absence of pathology. Quanitification of size, function, and hymodynamic performance can also be assessed. The heart can be imaged transthoracicly or transesophageal imaging can be used to monitor the heart during surgical procedures such as cardiac bypass or valve replacements.
The patient's electrocardiogram (ECG) may be obtained and is used for accurate timing of diastolic and systolic function.
Warning: The ECG is not used to diagnose cardiac arrhythmias and is not designed for long term cardiac rhythm monitoring.
Gynecology and Infertility Imaging Applications
This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, M Mode, color power Doppler (CPD), color Doppler (Color)Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The uterus, ovaries, adnexa, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally.
4
Interventional and Intraoperative Imaging Applications
This system transmits ultrasound energy into the various parts of the body using 2D, M-Mode, color Doppler (Color), color power Doppler (CPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images that provide quidance during interventional and intraoperative procedures. This system can be used to provide ultrasound quidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance during abdominal, vascular, and neurological intraoperative procedures.
- Warning: This system is not intended for use in providing guidance for central nerve blocks, i.e., the brain and spinal cord, or for ophthalmic applications.
Obstetrical Imaging Applications
This system transmits ultrasound energy into the pelvis of pregnant women using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), 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 transabdominally or transvaginally. CPD and color Doppler (Color) imaging is intended for high-risk pregnant women. High-risk pregnancy indications include, but are not limited to, multible pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus,
- Warning: To prevent injury or misdiagnosis do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been validated to be proven effective for these two uses. CPD, or Color 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 Doppler (Color), color power Doppler (CPD), pulsed wave (PW) Doppler, 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, M Mode, color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The prostate gland can be assessed for the presence or absence of pathology.
5
Superficial Imaging Applications
This system transmits ultrasound energy into various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), 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. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, and peripheral nerve blocks.
- Warning: This system is not intended for use in providing guidance for central nerve blocks, i.e., the brain and spinal cord, or for ophthalmic applications.
Vascular Imaging Applications
This system transmits ultrasound energy into the various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), 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.
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 or M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Dopler, CW Doppler, velocity color Doppler, 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 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.
The device's acoustic output limits are:
All applications:
| ISPTA (d) | 720 mW/cm² (Maximum) |
|---|---|
| Tls/Tib/Tlc | 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
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes resembling human profiles or faces, stacked one above the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2005
SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K043559
Trade Name: SonoSite High-Resolution Diagnostic Ultrasound System (C3 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: December 20, 2004 Received: December 27, 2004
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 High-Resolution Diagnostic Ultrasound System (C3 Series), as described in your premarket notification:
Transducer Model Number
2MHZ Doppler Pencil C8/8-5
7
C11/8-5
C15/4-2
C60/5-2
C60e/5-2
HFL38/12-5
HST/10-5
HST/12-7
HST/12-8
ICT/8-5
LAP/10-5
L25/10-5
L38/10-5
L38e/10-5
L52/10-5
L52-S/10-5
MPT/7-4
P/4-2
P/7-4
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:
8
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 nouticate 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 If you attire 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 other general micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Dorgenson
Image /page/8/Picture/7 description: The image shows a handwritten symbol or abbreviation that appears to be "fxr". The writing is in black ink and is slightly slanted. The background is plain white.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
9
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Fetal | N | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1 | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Pediatric | N | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | N | N | N | 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 | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | |||||||
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1 | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | N | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1 | |||||||
| Peripheral | Peripheral vessel | |||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
| 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 4.3- 1 Diagnostic Ultrasound Indications for Use Form – C3 System
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Hammic maging, Tissue Noter I. Only maddes Ooler Forer Bopper, Solor Doppler includes Velocity Color Doppler. Color Doppler can be Dopper imaging and inisting or guladino of assist in the placement of needles and catheters in vascular on other analonical combined will ally maging mode. This placement of nesser and earlines of previously dearced in K030949. An expanded intended use for imaging guidance for peripheral nerve blook procedures was previously deared in K033367.
Daniel A. Serman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043559
10
Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form - 2 MHz Doppler Pencil
Emil A. Bergman
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number
11
| SonoSite High-Resolution Ultrasound System (C3 Series) | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
| Transducer: | C8/8-5 8.0-5.0 MHz Curved 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 | |||||||
| N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | |||||||
| 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 | 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.) | ||||||||
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
| Transducer: | C11/8-5 8.0-5.0 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 | ||||||||
| B+M; B+PWD; | ||||||||
| B+CWD; | ||||||||
| B+CD | ||||||||
| Abdominal | N | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; | ||||||||
| B+CD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | N | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Fetal Imaging | Laparoscopic | |||||||
| B+M; B+PWD; | ||||||||
| B+CWD; | ||||||||
| B+CD | ||||||||
| & 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 | ||||||||
| B+M; B+PWD; | ||||||||
| B+CWD; | ||||||||
| B+CD | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal | ||||||||
| (card.) | N | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; | ||||||||
| B+CD | Note 1 | |||||||
| Other (spec.) | ||||||||
| B+M; B+PWD; | ||||||||
| B+CD | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | |||||||
| Other (spec.) |
Table 4.3- 3 Diagnostic Ultrasound Indications for Use Form – C8/8-5 Transducer
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic maging, Tissue Nole 1. Online Includes Color Fore. Bopper, continue a and Gelority Color Doppler. Color Doppler and be Dopper inlaging and inlaging for goldance on blogs). User event of needles and catheters in vascular or other anatomical structures was cleared in K030949.
Daniel A. Snyderman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043559
12
Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form - C11/8-5 Transducer
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Note 1. Only Includes Color Power Dopper, Color Pollor Dolor Pollor Doppler. Color Doppler an be Dopper maging and inloging or gologics or blogs; Uter Popply Marcelles in vasular or there analonical para ha combined will any maging moot. "India in a souse. An expanded intended use for imaging guidance for peripheral nerve blook procedures was previously cleared in K033367
Damil A. Olymm
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043559
Indications for Use
7 of 905 pages
13
| SonoSite High-Resolution Ultrasound System (C3 Series)
| System: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| C15/4-2 4.0-2.0 MHz Curved Array | |||||||||
| Transducer: | |||||||||
| Diagnostic ultrasound imaging or fluid flow analysis of the human | |||||||||
| Intended Use: | |||||||||
| 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 | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Fetal | N | N | N | B+M; B+PWD; | |||||
| B+CWD; | |||||||||
| B+CD | Note 1 | ||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| (Abdominal organs and | |||||||||
| vascular) | N | N | N | N | N | B+CD | Note 1 | ||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Fetal Imaging | |||||||||
| & Other | Pediatric | ||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Neonatal Cephalic | N | N | N | 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 | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non- | |||||||||
| Card.) | |||||||||
| Musculo-skel. | |||||||||
| (Convent.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Musculo-skel. | |||||||||
| (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; | |||
| B+CWD; | |||||||||
| B+CD | Note 1 | ||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal | |||||||||
| (card.) | |||||||||
| Other (spec.) | N | N | N | N | N | B+M; B+PWD; | |||
| B+CWD; | |||||||||
| B+CD | Note 1 | ||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 |
Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form - C15/4-2 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
A Qurt Includes Color Power Dopler, combined B and Color Power Doppler, 3-D maging, Tissue Hamonic masure, Tissue Note : Other includes Color Power Dopler, combined Band Color Power Chamble hisale hasing.
Dopler maging mor minad B and Color Dopler induses Versity Cher Dopler. Color Dopl combined with any imaging modelin 510(k) K030949.
David A. Lynn
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) gmbe6f-905 pages
K043559 Section 4.3
20
Indications for Use
14
| SonoSite High-Resolution Ultrasound System (C3 Series) | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ||||||||
| C60/5-2 5.0-2.0 MHz Curved Array | ||||||||
| Transducer: | ||||||||
| Diagnostic ultrasound imaging or fluid flow analysis of the human | ||||||||
| Intended Use: | ||||||||
| body as follows: | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | |
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | B+M; B+PWD; | ||||||
| B+CD | ||||||||
| Fetal | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Abdominal | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | B+M; B+PWD; | ||||||
| B+CD | Note 1 | |||||||
| Pediatric | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Convent.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. | ||||||||
| (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Peripheral | ||||||||
| Vessel | Other (spec.) |
Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form - C60/5-2 Transducer
Additional Comments:
A COITI (Offical Color Power Doppler, combined B and Color Power Doppler, 3-D maging, Tissue
Note 1: Other includes Color Power Linery, Color Donner includes Velocity Color D Note 1: Other includes Color Power Doppler, onmined Band Color Color Polor many of Color Dopler Cag he register and e Doppler imaging and imaging for guidanes of biopsy. Color Dopper noder Dobble Ook Bopper Ook Bopper Ook Bopper Ooke Bopper
combined with any imaging more in 156045 comotics was previously cleared in 510(K) K030949.
Erich Lyrum
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KD43559
15
| Table 4.3- 7 Diagnostic Ultrasound Indications for Use Form - C60e/5-2 |
|---|
| Transducer |
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | C60e/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 1 & 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 | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Convent.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. | ||||||||
| (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 |
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3-D maging, Tissue Hammonic maging, Tissue Noter . Other includes Color Fover Dopper, Gard Ookly Color Power Doppler. Color Doppler Color Doppler Color Doppler and be Dopper maging and inlaging to guidative of blogs). Other Doppics from Solor Sopper Ostice Oppion Boller andomical structures was previously cleared in 510(k) K030949.
Dymil A. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043559
16
| SonoSite High-Resolution Ultrasound System (C3 Series)
| HFL38/12-5 12.0-5.0 MHz Linear Array Transducer | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. | ||||||||
| (Superfic.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 |
Table 4.3- 8 Diagnostic Ultrasound Indications for Use Form - HFL38/12-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Auditional Oonnino Hoo.
Note 1: Other includes Color Power Doppler, 3-D Inaging, Tissee Hamming, Tissue Hammic Insue Note 1: Other includes Color Power Dopler, Color Power Doppler, S-D maging, Nor Dopper care (register color Dopler cap be Dopler Imaging and imaging for guidanes in the placer of needles and capped of there been and capacity of an arguist of other opper of other combined with any imaging mode. Includes imaging to assist in the pacentent of necure in 1995.
anatomical structures and an expanded intended use for imaging guidance for p
Daniel A. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043539
17
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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: | |||||||||
| Mode of Operation | |||||||||
| Clinical Application | Color | ||||||||
| Doppler | Combined | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | |||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| (Abdominal organs and | |||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & Other | Pediatric | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles.) | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Musculo-skel. | |||||||||
| (Superfic.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal | |||||||||
| (card.) | |||||||||
| Other (spec.) | B+M; B+PWD; | ||||||||
| B+CD | Note 1 | ||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 |
Table 4.3- 9 Diagnostic Ultrasound Indications for Use Form – HST/10-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
A Coll Lifer includes Color Power Doppler, 3-D imaging, Tssee Hamming, Tissue Hammin maging, Tissue
Note 1: Other includes Color Power Dopper, Color Donner includes Velocity Note 1: Other includes Color Power Doppler, combined Band Color Powel Doppler, 1936 Printent Magnigan
Doppler Imaging and imaging for guidance of biopsy. Color Doppler inclu combined with any imaging mode.
Prescription Use (Per 21 CFR 801.109)
David A. Symm
(Division Sign-Off) Division of Reproductive, and Radiological 510(k) Number
1
18
| Table 4.3-10 Diagnostic Ultrasound Indications for Use Form – HST/12-7 |
|---|
| Transducer |
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | HST/12-7 12.0-7.0 MHz Linear Array Transducer | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| B | M | PWD | CWD | Color | ||||||
| Doppler | Combined | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| General | ||||||||||
| (Track I only) | Specific | |||||||||
| (Tracks I & III) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| (Abdominal organs and | ||||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Intra-operative (Neuro.) | ||||||||||
| Laparoscopic | B+M; B+PWD; | |||||||||
| B+CD | ||||||||||
| Pediatric | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Small Organ (breast, | ||||||||||
| thyroid, testicles.) | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Musculo-skel. | ||||||||||
| (Superfic.) | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal | ||||||||||
| (card:) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | |||||||||
| Other (spec.) |
Additional Comments:
A (Urlinor) Our Power Dopler, combined B and Color Power Dopler, 3-D maging, Tissue Hammic Imaging, Tissue
Note 1: Other includes Color Power Case Denning includes Velocity Note 1: Other includes Color Power Dopper, comments of and Color Power Poppler, o Brintenia and Googler can be combined with any imaging mode.
Daniel A. Symm
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
19
| SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| System: | |||||||||
| Transducer: | HST/12-8 12.0-8.0 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) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | B+M; B+PWD; | |||||||
| B+CD | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles.) | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Musculo-skel. | |||||||||
| (Superfic.) | |||||||||
| Intra-luminal | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Trans-esophageal | ||||||||
| (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
Table 4.3- 11 Diagnostic Ultrasound Indications for Use Form – HST/12-8 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
A LIGIT Clorinal Color Power Doppler, combined B and Color Power Doppler, Tissue Hamonic maging, Tissue
Note 1: Other includes Color Power Chinary Cales Danaler Col Note 1: Other includes Color Power Doppler, comoned Band Color Powel Doppler, PD Integrily, Maging Maging Maging Maging combined with any imaging mode.
Eavid b. Lyman
(Division Sign-Off Division of Reproductive, Abdomina and Radiological Device 510(k) Number
20
| Table 4.3- 12 Diagnostic Ultrasound Indications for Use Form - 10178-5 | |
|---|---|
| Transducer |
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | ICT/8-5 8.0-5.0 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 | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| 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 | 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
Additional Comments:
Note 1: Other includes Color Power Doppler, contined B and Color Power Doppler, Tissue Harmonic maging, Tissue
Note 1: Other includes Color Power Chinane Catalogical vice Vel Note : Other Incudes Color Fower Dopper, Color Dopler in Chopler in Chor Doppler. Color Dopler can be Dopper imaging and maging to gultained in the place world of needles and capper of the bapter and a
combined with any imaging to assist in the placement of needles and cathet
Daniel A. Symm
(Division Sign-Off) Division of Reproductive, Abdomit and Radiological Devices 510(k) Number
21
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | LAP/10-5 10.0-5.0 MHz Linear Array Laparoscopic 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) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
Table 4.3- 13 Diagnostic Ultrasound Indications for Use Form – LAP/10-5 Laparoscopic Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Note I I waging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode.
David A. Ingram
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number
22
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| 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: | ||||||||
| 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 | B+M; B+CD | Note 1 | |||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | B+M; B+CD | Note 1 | ||||
| Fetal Imaging | Intra-operative (Neuro.) | |||||||
| Laparoscopic | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | N | N | N | B+M; B+CWD; | ||||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | N | N | N | B+M; B+CD | Note 1 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Convent.) | N | N | N | B+M; B+CD | Note 1 | |||
| Musculo-skel. | ||||||||
| (Superfic.) | N | N | N | B+M; B+CD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | N | N | N | B+M; B+CD | Note 1 |
Table 4.3- 14 Diagnostic Ultrasound Indications for Use Form - L25/10-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Noppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Imaging to assist in the placement of needles and catheters in vascular or other anatomical structures was previously cleared in K030949. An expanded intended use for imaging guidance for peripheral nerve block procedures was previously cleared in K033367.
David A. Ingram
(Division Sign-Off) Division of Renroduc tive Ah and Ra 510(k) Numbe
23
| Table 4.3- 15 Diagnostic Ultrasound Indications for Use Form - L38/10-5 | |
|---|---|
| Transducer |
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L38/10-5 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 | Other | ||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Fetal Imaging | ||||||||
| & Other | Intra-operative (Neuro.) | |||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. | ||||||||
| (Superfic.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 |
Additional Comments:
Note : Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Hammonic maging, Tissue Note 1: Offer Incudes Color Power Dopper, Color Dopler includes Velocity Color Doppler Color Doppler and be Doptier imaging and inliging to guidatice of biopier haddes and catheters piras outher opper anatomical combined with any into e. Integrig to assist in the placement of needing guidance for peripheral nerve block procedures was previously cleared in K033367.
David A. Seymann
(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 510jkj Number _
24
Table 4.3- 16 Diagnostic Ultrasound Indications for Use Form - L38e/10-5 Transducer
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L38e/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 | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | B+M; B+PWD; | |||||||
| B+CD | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. | ||||||||
| (Superfic.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
AQuirtTorrati O'OrHTHOTHES :
Note 1: Other includes Color Power Doppler, 3-D major , Tissee Harmonic maging, Tissue Harmonic maging, Tissue Note 1: Oher Includes Color Power Doppler, Color Dopler in Color in Color Doctory Color Doctor of Color Dopler can be Dopler Imaging and imaging for guidatice of bidging to assist in the placement of needes and cather any and repear of research of necessary of needes and cather combined with any imaging mode. Includes inlaging to about in the processed in the procedures.
Daniel A. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043559
25
| Table 4.3- 17 Diagnostic Ultrasound Indications for Use Form - L52/10-5 |
|---|
| Transducer |
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L52/10-5 10.0-5.0 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 I only) | Specific | |||||||
| (Tracks 1 & 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 | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Fetal Imaging | ||||||||
| & Other | Intra-operative (Neuro.) | |||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. | ||||||||
| (Superfic.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Other (spec.) |
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Noter : Online manager only : One Deppler includes Velocity Color Doppler includes Velocity Color Doppler can be Dopper maging and maging to guance of blogs). Universe volong of the Dopper - Gold Dopper - Gold Dopper dence structures was previously cleared in K030949.
David A. Leppan
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
26
| Table 4.3- 18 Diagnostic Ultrasound Indications for Use Form – L52-S/10-5 |
|---|
| Transducer |
| System: | SonoSite High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L52-S/10-5 10.0-5.0 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 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 | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Fetal Imaging | ||||||||
| & Other | Intra-operative | |||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Pediatric | ||||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. | ||||||||
| (Superfic.) | N | N | N | 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 | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Peripheral | ||||||||
| Vessel | Other (spec.) |
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3-D Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode.
Daniel A. Simpson
(Division Sign-Off) Division of roductive, Abdom and Rad 510(k) Numb
27
Table 4.3- 19 Diagnostic Ultrasound Indications for Use Form - MPT/7-4 Trans-Esophageal Echocardiography Transducer
| System: | SonoSite High-Resolution Ultrasound System (C3 series) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | MPT/7-4 7.0-4.0 MHz Trans-esophageal Echocardiography 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) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | 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 Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | N | N | N | N | N | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | ||||||||
| 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, 3-D Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler can be combined with any imaging mode.
Prescription Use (Per 21 CFR 801.109)
David A. Lyman
(Division Sign-Division of Reproductive, Abdomi and Radiolog 510(k) Numbe
Indications for Use
28
| System: | SonoSite High-Resolution Ultrasound System (C3 series) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | P/4-2 4.0-2.0 MHz Phased Array Transducer | ||||||||||
| 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 I & III) | B | M | PWD | CWD | Color | ||||||
| Doppler | Combined | ||||||||||
| (Spec.) | Other | ||||||||||
| (Spec.) | |||||||||||
| Ophthalmic | Ophthalmic | B+M; B+PWD | |||||||||
| B+CD | Note 1 | ||||||||||
| Fetal | N | N | N | N | B+M; B+PWD | ||||||
| B+CD | Note 1 | ||||||||||
| Abdominal | |||||||||||
| Intra-operative | |||||||||||
| (Abdominal organs and | |||||||||||
| vascular) | N | N | N | N | N | B+M; B+PWD; | |||||
| B+CWD; B+CD | Note 1 | ||||||||||
| N | N | N | N | B+M; B+PWD | |||||||
| B+CD | Note 1 | ||||||||||
| Intra-operative (Neuro.) | |||||||||||
| Fetal | |||||||||||
| Imaging | |||||||||||
| & Other | Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | B+M; B+PWD | Note 1 | |||||
| Small Organ (breast, | |||||||||||
| thyroid, testicles.) | N | N | N | N | B+M; B+PWD | ||||||
| B+CD | Note 1 | ||||||||||
| Neonatal Cephalic | N | N | N | 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 | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD | ||||||
| B+CD | Note 1 | ||||||||||
| Musculo-skel. (Superfic.) | |||||||||||
| Intra-luminal | |||||||||||
| Other (spec.) | |||||||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD: | |||||
| B+CWD; B+CD | Note 1 | ||||||||||
| 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 | B+M; B+PWD; B+CD | Note 1 | ||||
| Other (spec.) |
Table 4.3- 20 Diagnostic Ultrasound Indications for Use Form - P/4-2 Phased Array 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, 3-D Imaging, Tissue Harmonic maging, Tissue Noter : Onlier Includes Color Fower Doppier, confident includes Velocity Color Doppler and ed Dopper maging to gate inis in gate, includes inaging to assist in the placement of needles and cathelers in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
David A. Sygman
enroductive,
Indications for Use
29
Table 4.3- 21Table 4.3- 20 -- Diagnostic Ultrasound Indications for Use Form -- P/7-4 Phased Array Transducer Intended Use Form
| System: | SonoSite High-Resolution Ultrasound System (C3 series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | P/7-4 7.0-4.0 MHz Phased Array Transducer | |||||||
| 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.) | ||||||||
| Mode of Operation | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | N | N | N | N | B+M; B+PWD | ||
| B+CD | Note 1 | |||||||
| Abdominal | N | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | B+M; B+PWD | Note 1 | ||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | N | N | N | N | B+M; B+PWD | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | N | N | N | 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 | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | |||||||
| 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 | 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:
Additional Other includes Color Power Doppler, combined B and Color Power Doppler, S-D Imaging, Tissue Hamonic maging, Tissue Note 1: Other includes Color Power Dopper includes Velocity Color Doppler of Only Color Color Color Color Color Color Color Color Color Color Color Color Color Color Color So Dopper imaging and imaging for guddined of blopsy. Ollor Dopper Industry of Select Occurrent of needles and cathers in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
David A. Bergman
(Division Sic Division of P and Radi 510kk) Nu
Indications for Use