(12 days)
No
The device description focuses on standard ultrasound functionalities and image processing, with no mention of AI, ML, or related concepts.
No.
The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis", which is for diagnostic purposes, not therapeutic.
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" mentions that the system "provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes." The listed predicate devices also include "Diagnostic Ultrasound System" in their names.
No
The device description explicitly states it is a "highly portable, software controlled ultrasound system" and mentions hardware components like transducers, ECG cable assembly, and a main system control panel.
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 for diagnosis, monitoring, or screening.
- Device Function: The SonoSite TITAN™ is an ultrasound system. It uses sound waves to create images of internal structures of the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This involves imaging the body directly, not analyzing samples.
Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended uses of the SonoSite TITAN™ high-resolution ultrasound system as defined by FDA guidance documents, are:
Fetal - OB/GYN
Abdominal
Trans-rectal
Intra-operative (Abdominal organs and vascular)
Trans-vaginal
Laparoscopic
Trans-urethral
Pediatric
Musculo-skel. (Conventional)
Small Organ (breast, thyroid, testicles.)
Musculo-skel. (Superficial)
Neonatal Cephalic
Cardiac Adult
Adult Cephalic
Cardiac Pediatric
Peripheral vessel
Typical examinations performed using the SonoSite TITAN™ high-resolution ultrasound system 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. The ECG is not used to diagnose cardiac arrhythmias and is not designed for 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 quidance 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 Doppler (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 transvaqinally. 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX, 90-LLZ
Device Description
The SonoSite TITAN™ high-resolution ultrasound systemis 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 TITAN™ high-resolution ultrasound system 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
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-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel, eyes (Ophthalmic)
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.
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
KO30949
D02576A-510(K) Submission-SonoSite TITAN high-resolution ultrasound system 06-Mar-2003
APR 0 7 2003 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: | March 6, 2003 |
- 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 TITAN™ high-resolution ultrasound system (subject to change)
Classification Names
| Name | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Picture Archiving And Communications System | 892.2050 | 90-LLZ |
3) Identification of the predicate or legally marketed device:
SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the Philips Ultrasound HDI® 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 TITAN™ high-resolution ultrasound systemis 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 TITAN™ high-resolution ultrasound system 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 TITAN™ high-resolution ultrasound system 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
510(K) Summary Of Safety And Effectiveness
2
- f. EN 60601-1-2:2001, European Norm, Medical Electrical Equipment. General 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. Requirements for for Safety-Section 25. Specification Particular 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 i.
- Medical Ultrasound Safety. American Institute of Ultrasound in Medicine k. (AIUM), 1994
- NEMA PS3.15 2000, Digital Imaging and Communications in Medicine . (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
- g. 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 TITAN™ high-resolution ultrasound system as defined by FDA guidance documents, are:
| Fetal - OB/GYN | Trans-rectal |
|---|---|
| Abdominal | Trans-vaginal |
| Intra-operative | |
| (Abdominal organs and vascular) | Trans-urethral |
| Laparoscopic | Musculo-skel. (Conventional) |
| Pediatric | Musculo-skel. (Superficial) |
| Small Organ | |
| (breast, thyroid, testicles.) | Cardiac Adult |
| Neonatal Cephalic | Cardiac Pediatric |
| Adult Cephalic | Peripheral vessel |
3
Typical examinations performed using the SonoSite TITAN™ high-resolution ultrasound system 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.
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 quidance 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 Doppler (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 transvaqinally. 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.
CPD or DCPD images can be used as an adjunctive method, not as a screening tool, Warning: 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
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, resembling an eagle or bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 7 2003
SonoSite, Inc. % Ms. Laura Danielson TUV Product Service 1775 Old Highway 8 NW Suite 104 NEW BRIGHTON MN 55112-1891
Re: K030949
Trade Name: TITANTM High-Resolution Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 IYN and LLZ Dated: March 25, 2003 Received: March 26, 2003
Dear Ms. Danielson:
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 TITAN™ High-Resolution Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C11/7-4 |
|---|
| C11/8-5 |
| C15/4-2 |
| C60/5-2 |
| HST/10-5 |
| ICT/7-4 |
| C8/8-5 |
7
ICT/8-5 L25/10-5 L38/10-5 L52/10-5 L52-S/10-5 2MHz Doppler Pencil
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 letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (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.
Sincerely yours,
David Le. Hyman
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
8
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | N/A | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| 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) | N | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; | ||||||||
| B+CD | Note 1 | |||||||
| Fetal Imaging | Intra-operative (Neuro.) | |||||||
| Laparoscopic | N | N | N | B+M; B+PWD | Note 1 | |||
| & Other | 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 | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| 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 | Peripheral vessel | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 |
Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form - TITAN 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 lmaging, Tissue Harmonic Imaging for guidance of biopsy. Included with this 510k are imaging to assist in the placement of needles and cathelers in vascular or other anatomical structures. Musculo-skel. (Superfic.) imaging previously cleared in 510(k) K003399. Included with this 510(k) is picture programs and storage functionality previously cleared in 510(k) K023957.
Color Doppler includes Velocity Color Doppler. Division
Prescription Use (Per 21 CFR 801.109) Indications for Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030949
Section 4.3
25 of 961 pages
9
Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form - C11/7-4 Transducer
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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) | N | N | N | N | N | B+M; B+PWD; | ||||
| B+CWD; B+CD | Note 1 | |||||||||
| Intra-operative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal Imaging | ||||||||||
| & 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 | 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.) | 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 |
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 Inaging for guidance of biopsy. 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.
Prescription Use (Per 21 CFR 801.109)
David A. Bergman
(Division Sign-C Division of Reproductive, and Radiological D 510(k) Numbe
10
| System: | SonoSite TITAN™ high-resolution ultrasound system | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | N | N | N | N | N | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles.) | N | N | N | N | N | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | ||||||||
| Neonatal Cephalic | |||||||||
| 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.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| 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 | ||||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 |
Table 4.3- 3 Diagnostic Ultrasound Indications for Use Form - C11/8-5 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, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy. 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.
Prescription Use (Per 21 CFR 801.109)
Daniel R. Lyman
(Division Sign-Off) Division of Reproductive, A and Radiological D 510(k) Number
Indications for Use
11
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 | N | N | N | B+M; B+PWD | 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 | B+M; B+PWD | Note 1 | |||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | B+M; B+PWD | Note 1 | |||||
| Pediatric | N | N | N | |||||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | N | N | N | B+M; B+PWD | Note 1 | |||
| Neonatal Cephalic | N | N | N | 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.) | N | N | N | B+M; B+PWD | 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- 4 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:
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. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
28
Color Doppler includes Velocity Color Doppler.
Prescription Use (Per 21 CFR 801.109)
David R. Legrown
(Division Division c productive. Abdo and Radiological Dev 510(k) Numbe
Section 4.3
of 961 pages
12
Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form - C60/5-2 Transducer
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | |||||||||
| Pediatric | N | N | N | 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 | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| 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. 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.
Prescription Use (Per 21 CFR 801.109)
David A. Leymm
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological De 510(k) Number
Indications for Use
13
Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form - HST/10-5 Transducer
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||
|---|---|---|---|---|---|---|---|---|
| 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) | 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 | Note 1 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | 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:
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. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Musculo-skel. (Superfic.) imaging previously cleared in 510(k) K003399.
Color Doppler includes Velocity Color Doppler.
Prescription Use (Per 21 CFR 801.109)
David R. Segmann
(Division Sign-Off) Division of Reproductive, A and Radiologi 510(k) Number
14
Table 4.3- 7 Diagnostic Ultrasound Indications for Use Form - ICT/7-4 Transducer
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | ICT/7-4 7.0-4.0 MHz Intracavitary Transducer | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as | |||||||||
| follows: | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | Specific | Color | Combined | Other | ||||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | (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 | Laparoscopic | |||||||||
| & Other | 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 | Peripheral vessel | |||||||||
| 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 Inaging for guidance of biopsy. 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.
Prescription Use (Per 21 CFR 801.109)
David M. Segmon
(Division Sic Division of Reproductive, A and Radi 510(k) Numb
Indications for Use
15
Table 4.3- 8 Diagnostic Ultrasound Indications for Use Form -- C8/8-5 Transducer
| System: | SonoSite TITAN™ high-resolution ultrasound system | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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: | ||||||||
| 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.) |
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. 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.
Prescription Use (Per 21 CFR 801.109)
Daniel A. Hyman
(Division Sign-Off) Division of Reproductive, A and Radiological Devic 510(k) Number
16
| System: | SonoSite TITAN™ high-resolution ultrasound system | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | ICT/8-5 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 Imaging | |||||||||
| & Other | Fetal | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid, testicles.) | |||||||||
| 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.) |
Table 4.3- 9 Diagnostic Ultrasound Indications for Use Form – ICT/8-5 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, combined B and Directional Color Power Doppler, 3-D Insting , Tissue Harmonic Imaging for guidance of biopsy. 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.
Prescription Use (Per 21 CFR 801.109)
Daniel R. Leyman
(Division Sign-Of Division of Reproductive, Abdomir and Radiological Devices 510(k) Number
17
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | N | N | N | B+M; B+PWD | Note 1 | |||||
| Abdominal | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Intra-operative (Abdominal | ||||||||||
| organs and vascular) | N | N | N | B+M; B+PWD | Note 1 | |||||
| Fetal Imaging | Intra-operative (Neuro.) | |||||||||
| Laparoscopic | N | N | N | B+M; B+PWD | Note 1 | |||||
| & Other | Pediatric | |||||||||
| Small Organ (breast, thyroid, testicles.) | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Neonatal Cephalic | ||||||||||
| 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 | B+M; B+PWD | Note 1 | |||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | N | N | N | N | 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- 10 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, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Musculo-skel. (Superfic.) imaging previously cleared in 510(k) K003399.
Color Doppler includes Velocity Color Doppler.
Prescription Use (Per 21 CFR 801.109)
David R. Segarra
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Section 4.3
34 of 961 pages
18
Table 4.3- 11 Diagnostic Ultrasound Indications for Use Form - L38/10-5 Transducer
| System: | SonoSite TITAN™ high-resolution ultrasound 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 | N | N | N | B+M; B+PWD | Note 1 | |||
| Abdominal | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | N | N | N | B+M; B+PWD | Note 1 | |||
| Fetal Imaging | Intra-operative (Neuro.) | |||||||
| Laparoscopic | N | N | N | B+M; B+PWD | Note 1 | |||
| & Other | Pediatric | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | ||||||||
| 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 | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | N | N | N | N | 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 |
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 Harmonic Imaging for guidance of biopsy. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical stuctures. Musculo-skel. (Superfic.) imaging previously cleared in 510(k) K003399.
Color Doppler includes Velocity Color Doppler.
Prescription Use (Per 21 CFR 801.109)
Daniel A. Legrain.
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 10(k) Number
19
| Table 4.3- 12 Diagnostic Ultrasound Indications for Use Form – L52/10-5 & L52-S/10-5 | |
|---|---|
| Transducers |
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | L52/10-5 and L52S/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 | B+M; B+PWD | Note 1 | |||||
| Abdominal | N | N | N | N | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Intra-operative (Abdominal | ||||||||||
| organs and vascular) | N | N | N | B+M; B+PWD | Note 1 | |||||
| Fetal Imaging | Intra-operative (Neuro.) | |||||||||
| Laparoscopic | N | N | N | B+M; B+PWD | Note 1 | |||||
| & 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 | 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.) | N | N | N | B+M; B+PWD | Note 1 | |||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | N | N | N | N | B+M; B+PWD; | ||||
| 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:
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. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Musculo-skel. (Superfic.) imaging previously cleared in 510(k) K003399.
Color Doppler includes Velocity Color Doppler.
Prescription Use (Per 21 CFR 801.109)
Daniel A. Leyman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
20
Table 4.3- 13 Diagnostic Ultrasound Indications for Use Form - 2 MHz Doppler Pencil
| System: | SonoSite TITAN™ high-resolution ultrasound system | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||
| 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 | Cardiac Adult | N | |||||||||
| Cardiac Pediatric | N | ||||||||||
| Trans-esophageal (card.) | |||||||||||
| Other (spec.) | |||||||||||
| Peripheral | |||||||||||
| Vessel | Peripheral vessel | ||||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Prescription Use (Per 21 CFR 801.109)
David A. Seligmann
(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices 5 1 (Xk) Number
Indications for Use