(14 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and measurement capabilities. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The image processing described is standard for ultrasound systems.
No
The device is described as being used for "Diagnostic ultrasound imaging or fluid flow measurement" and "clinical diagnostic purposes," indicating a diagnostic rather than therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow measurement 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."
No
The device description explicitly states it is a "software controlled ultrasound system" and mentions hardware components like transducers that are not detachable from the system. It also describes the process of sound waves being reflected back to the transducer and converted into electrical signals for processing and display, indicating a hardware component is integral to the device's function.
Based on the provided information, 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 device is an ultrasound system. Ultrasound uses sound waves to create images of internal body structures. It is a non-invasive imaging modality that does not involve testing samples taken from the body.
- Intended Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow measurement of the human body." This is consistent with the function of an ultrasound system, not an IVD.
- Device Description: The description details the technical aspects of an ultrasound system, including transducers, imaging modes (2D, Doppler), and measurement capabilities for anatomical structures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, this device falls under the category of a medical imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended clinical applications of the SonoSite Hand-Carried Ultrasound System (PowerSeries), as defined by FDA guidance documents are below. These applications are cumulative, as specific applications are dependent on the transducer attached to the System.
Fetal - OB/GYN | Musculo-skeletal (conventional) |
---|---|
Laparoscopic | Musculo-skeletal (superficial) |
Intraoperative (abdominal organs and vascular) | Neonatal Cephalic |
Abdominal | Pediatric |
Small Organ (breast, thyroid, testicle) | Cardiac (adult) |
Trans-vaginal | Cardiac (pediatric) |
Trans-rectal | Peripheral Vessel |
Typical examinations performed using the SonoSite Hand-Carried Ultrasound System (PowerSeries) may include the following. Again, the clinical applications themselves, and the modes of operation discussed within a clinical application, are dependent on the transducer attached to the system.
Abdomen:
This system transmits ultrasound energy into the upper and lower quadrants of the abdomen of an adult or pediatric patient to obtain 2D, CPD, PowerMap DCPD, Tissue Harmonic Imaging, or PW and CW Doppler images, which can be used to assess the presence and extent of some diseases and injuries.
Small Parts And Superficial Structures:
This system transmits ultrasound energy into the superficial structures of body to obtain 2D, CPD, or PW Doppler images of normal structure and some pathologies of the breast, thyroid, superficial soft tissue, shoulder joints, wrist, ankle, and knee, which can be used to assess the presence and extent of some diseases and iniuries.
Pediatric:
This system transmits ultrasound energy into the abdomen, pelvis and superficial structures of pediatric patients to obtain 2D, CPD, PowerMap DCPD, Tissue Harmonic Imaging, or PW and CW Doppler images of the abdominal organs, great vessels, pelvic structures, and pediatric hips, which can be used to assess the presence and extent of some diseases and injuries.
Cardiac:
This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap DCPD, M-mode, Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structures. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to assess the presence and extent of some injuries and diseases. As available, the ECG is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac rhythms and is not designed for long term cardiac rhythm monitoring.
Neonates:
Abdomen, cranium, pelvis and heart in neonates that weigh less than 1500 / kodoment or are less than 32 weeks gestation: This system transmits ultrasound gramo or are toos than, abdomen, pelvis soft tissue or heart of patients to obtain onergy mis and chanian DCPD, M-mode, or PW and CW Doppler images. These images will be used to assess the presence and extent of some diseases or injuries. Some examples of the pathology that ultrasound is used for include: Cranium - hemorrhage, ischemia, shunt placement and dilated ventricles; Organs - Thomormage, Is disease, gallbladder disease; Pelvis - ovarian / lottominal organo - athology and testicular disease; Soft tissue/superficial tissue - hip, lymph nodes and superficial cysts.
GYN/Infertility:
This system transmits ultrasound energy into the lower abdomen or vagina of a female patient to obtain 2D, CPD, PowerMap DCPD, M-mode, Tissue Harmonic Imaging, or PW Doppler images of the reproductive system, which can be used to assess the presence and extent of disease in the female pelvic organs, monitor ovarian follicle size, and as an aid in chorionic villi sampling (CVS) procedures.
Obstetrics:
This system transmits ultrasound energy into the abdomen or vagina of a pregnant woman to obtain 2D, M-mode, Tissue Harmonic Imaging, or PW Doppler images of a fetus, which can be used to estimate gestational age, number and weight, and assess the presence and extent of disease and confirm viability. CPD or PowerMap DCPD imaging is intended for high-risk pregnant women. High risk pregnancy indications include, but are not limited to multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus.
WARNING:
CPD or PowerMap 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).
Prostate:
This system transmits ultrasound energy through the prostate of an adult patient to obtain 2D, CPD, or PW Doppler images of structures, which can be used to assess the presence and extent of disease or injury. Measurements are available to calculate the volume of the prostate gland.
Vascular:
This system transmits ultrasound energy into various parts of the body using 2D, CPD, PowerMap DCPD, Tissue Harmonic Imaging, or PW Doppler to obtain ultrasound images. The most common structures imaged are carotid arteries, untrasound images. The most common causels in the abdomen, and peripheral line decep volns in the anno and adjology purposes. The system provides ultrasound access, and intervontional fully in the placement of needles and catheters in vascular or other anatomical structures.
Diagnostic ultrasound imaging or fluid flow measurement of the human body
Additional Comments:
Note 1: Other indludes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap Directional Color Power Doppler, 3-D Integing, Tissue Harmonic Imaging for guidance of biopsy previously cleared through : 10(k) K014116. Included with this 510k are imaging to assist in the placement of needles and calheters in vascular or other anatomical structures.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The SonoSite Hand-Carried Ultrasound System (PowerSeries) is a highly portable, software controlled ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D and other modes as Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and PowerMap Directional Color Power Doppler, or a combination of these modes with 2D. These modes of operation are dependent on the type of transducer that is attached to the system, with the exception of 2D.
The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System may include PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, non-diagnostic ECG capability for the collection of data for M-mode measurements, measurements and calculations, image storage and review, printing, and recording capabilities. Additionally, the system provides ultrasound guidance to assist in the placement of needles and catheters in vascular or other anatomical structures.
The SonoSite Hand-Carried Ultrasound System (PowerSeries) may have 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. The transducer is not detachable from the System.
Frequency Range: 2.0 - 10.0 MHz
Transducer Types: Linear array, Curved array, Intracavitary array
The SonoSite Hand-Carried Ultrasound System is designed to comply with the standards listed below.
EN 60601-1:1997
CAN/CSA C22.2, No. 601.1:1990 + Amendments
UL 2601-1:1997
JIS-T-100X-Series
EN 60601-1-1:1993 + Amendments
EN 60601-1-2:1993 + Amendments
RTCA/D0160D: 1997
ISO 10993 Biocompatibility Series
ANSI/AAMI EC53:1995 + Amendments, except for sections 4.4 and 4.5.9
CEI/IEC 61157:1992
Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1998
Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1993
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD2-1998
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 waves into the electrical signals that are processed and displayed as 2D or Mmode images. Doppler shift caused by blood flow is displayed, as available, as mode linager as spectrum analysis. The cumulative modes of this device (2D, PW Doppler, CW Doppler, Color Power Doppler, and PowerMap Directional Color Power Doppler) 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). 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:
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)
All applications:
The limits are the same as predicate Track 3 devices.
Mentions image processing
Sound waves are reflected back to the transducer and waves into the electrical signals that are processed and displayed as 2D or Mmode images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal - OB/GYN, Laparoscopic, Intraoperative (abdominal organs and vascular), Abdominal, Small Organ (breast, thyroid, testicle), Trans-vaginal, Trans-rectal, Musculo-skeletal (conventional), Musculo-skeletal (superficial), Neonatal Cephalic, Pediatric, Cardiac (adult), Cardiac (pediatric), Peripheral Vessel, Upper and lower quadrants of the abdomen, Superficial structures of body, Shoulder joints, Wrist, Ankle, Knee, Pelvis, Thorax, Heart, Great vessels, Anatomical or pathologic structures, Cranium, Ovaries, Testicles, Hip, Lymph nodes, Superficial cysts, Reproductive system, Prostate gland, Carotid arteries, Renal arteries, Peripheral vessels in the arms and legs.
Indicated Patient Age Range
Adult, Pediatric, Neonates (less than 1500 g or less than 32 weeks gestation), Pregnant women
Intended User / Care Setting
Clinician; Not specified but likely professional healthcare setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K014116, K010374, K961459, K993624
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
MAY 3 1 2002
K021628
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510(K) Summary Of Safety And Effectiveness
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with Title 21, Part 807, Section 92.
Submitter's name, address, telephone number, contact person: 1)
Michael A. Hoffman Director - Regulatory Affairs and Quality Systems SonoSite, Inc.
21919 30th Drive SE Bothell, WA 98021-3904
(425) 951 - 1297
E-mail: michael.hoffman@sonosite.com
Date prepared: April 24, 2002
Name of the device, including the trade or proprietary name if applicable, 2) the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
SonoSite Hand-Carried Ultrasound System (PowerSeries) (subject to change)
1
K021628
2076
Classification Names
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 |
3) Identification of the predicate or legally marketed device:
SonoSite, Inc. believes that System described in this Submission is substantially equivalent to predicate devices that include the SonoSite Hand-Carried Ultrasound System (K014116) and (K010374), the Advanced Technology Laboratories (ATL) HDI® 5000 Ultrasound System (K961459), and the Dymax Corp.Site-Rite 3 Ultrasound Scanner (K993624). Where applicable, this new Submission references sections of K014116 to signify that the sections in this Submission remain the same as the predicate device.
4) Device Description:
The SonoSite Hand-Carried Ultrasound System (PowerSeries) is a highly portable, software controlled ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D and other modes as Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and PowerMap™ Directional Color Power Doppler, or a combination of these modes with 2D. These modes of operation are dependent on the type of transducer that is attached to the system, with the exception of 2D.
The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System may include PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, non-diagnostic ECG capability for the collection of data for M-mode measurements, measurements and calculations, image storage and review, printing, and recording capabilities. Additionally, the system provides ultrasound guidance to assist in the placement of needles and catheters in vascular or other anatomical structures.
The SonoSite Hand-Carried Ultrasound System (PowerSeries) may have 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. The transducer is not detachable from the System.
2
- محمد الموارث الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق | י מי | ্ |
---|---|---|
2000 | 8 | ﮯ ﮐﮩﺎ ﮐﮧ ﺍﯾﮏ |
20 | 1 | |
15 |
Frequency Range: | 2.0 - 10.0 MHz |
---|---|
Transducer Types: | Linear array |
Curved array | |
Intracavitary array |
The SonoSite Hand-Carried Ultrasound System is designed to comply with the standards listed below.
EN 60601-1:1997 |
---|
CAN/CSA C22.2, No. 601.1:1990 + Amendments |
UL 2601-1:1997 |
JIS-T-100X-Series |
EN 60601-1-1:1993 + Amendments |
EN 60601-1-2:1993 + Amendments |
RTCA/D0160D: 1997 |
ISO 10993 Biocompatibility Series |
ANSI/AAMI EC53:1995 + Amendments, except for sections 4.4 and 4.5.9 |
CEI/IEC 61157:1992 |
Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), |
1994 |
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output |
Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in |
Medicine, 1998 |
Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound |
Equipment, American Institute of Ultrasound in Medicine, 1993 |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, |
NEMA UD2-1998 |
5) Intended Use:
The intended clinical applications of the SonoSite Hand-Carried Ultrasound System (PowerSeries), as defined by FDA guidance documents are below. These applications are cumulative, as specific applications are dependent on the transducer attached to the System.
Fetal - OB/GYN | Musculo-skeletal (conventional) |
---|---|
Laparoscopic | Musculo-skeletal (superficial) |
Intraoperative (abdominal organs and | |
vascular) | Neonatal Cephalic |
Abdominal | Pediatric |
Small Organ (breast, thyroid, testicle) | Cardiac (adult) |
Trans-vaginal | Cardiac (pediatric) |
Trans-rectal | Peripheral Vessel |
3
K021628
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Typical examinations performed using the SonoSite Hand-Carried Ultrasound System (PowerSeries) may include the following. Again, the clinical applications themselves, and the modes of operation discussed within a clinical application, are dependent on the transducer attached to the system.
Abdomen:
This system transmits ultrasound energy into the upper and lower quadrants of the abdomen of an adult or pediatric patient to obtain 2D, CPD, PowerMap DCPD, Tissue Harmonic Imaging, or PW and CW Doppler images, which can be used to assess the presence and extent of some diseases and injuries.
Small Parts And Superficial Structures:
This system transmits ultrasound energy into the superficial structures of body to obtain 2D, CPD, or PW Doppler images of normal structure and some pathologies of the breast, thyroid, superficial soft tissue, shoulder joints, wrist, ankle, and knee, which can be used to assess the presence and extent of some diseases and iniuries.
Pediatric:
This system transmits ultrasound energy into the abdomen, pelvis and superficial structures of pediatric patients to obtain 2D, CPD, PowerMap DCPD, Tissue Harmonic Imaging, or PW and CW Doppler images of the abdominal organs, great vessels, pelvic structures, and pediatric hips, which can be used to assess the presence and extent of some diseases and injuries.
Cardiac:
This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap DCPD, M-mode, Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structures. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to assess the presence and extent of some injuries and diseases. As available, the ECG is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac rhythms and is not designed for long term cardiac rhythm monitoring.
4
K621628
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Neonates:
Abdomen, cranium, pelvis and heart in neonates that weigh less than 1500 / kodoment or are less than 32 weeks gestation: This system transmits ultrasound gramo or are toos than, abdomen, pelvis soft tissue or heart of patients to obtain onergy mis and chanian DCPD, M-mode, or PW and CW Doppler images. These images will be used to assess the presence and extent of some diseases or injuries. Some examples of the pathology that ultrasound is used for include: Cranium - hemorrhage, ischemia, shunt placement and dilated ventricles; Organs - Thomormage, Is disease, gallbladder disease; Pelvis - ovarian / lottominal organo - athology and testicular disease; Soft tissue/superficial tissue - hip, lymph nodes and superficial cysts.
GYN/Infertility:
This system transmits ultrasound energy into the lower abdomen or vagina of a female patient to obtain 2D, CPD, PowerMap DCPD, M-mode, Tissue Harmonic Imaging, or PW Doppler images of the reproductive system, which can be used to assess the presence and extent of disease in the female pelvic organs, monitor ovarian follicle size, and as an aid in chorionic villi sampling (CVS) procedures.
Obstetrics:
This system transmits ultrasound energy into the abdomen or vagina of a pregnant woman to obtain 2D, M-mode, Tissue Harmonic Imaging, or PW Doppler images of a fetus, which can be used to estimate gestational age, number and weight, and assess the presence and extent of disease and confirm viability. CPD or PowerMap DCPD imaging is intended for high-risk pregnant women. High risk pregnancy indications include, but are not limited to multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus.
WARNING:
CPD or PowerMap 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).
Prostate:
This system transmits ultrasound energy through the prostate of an adult patient to obtain 2D, CPD, or PW Doppler images of structures, which can be used to assess the presence and extent of disease or injury. Measurements are available to calculate the volume of the prostate gland.
5
K0216.28
60fb
Vascular:
This system transmits ultrasound energy into various parts of the body using 2D, CPD, PowerMap DCPD, Tissue Harmonic Imaging, or PW Doppler to obtain ultrasound images. The most common structures imaged are carotid arteries, untrasound images. The most common causels in the abdomen, and peripheral line decep volns in the anno and adjology purposes. The system provides ultrasound access, and intervontional fully in the placement of needles and catheters in vascular or other anatomical structures.
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 waves into the electrical signals that are processed and displayed as 2D or Mmode images. Doppler shift caused by blood flow is displayed, as available, as mode linager as spectrum analysis. The cumulative modes of this device (2D, PW Doppler, CW Doppler, Color Power Doppler, and PowerMap™ Directional Color Power Doppler) 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). 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:
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) |
All applications:
The limits are the same as predicate Track 3 devices.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 31 2002
SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K021628
Trade Name: SonoSite Hand-Carried Ultrasound System (PowerSeries) 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 Regulatory Class: II Product Code: 90 IYN and IYO Dated: May 16, 2002 Received: May 17, 2002
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the SonoSite Hand-Carried Ultrasound System, as described in your premarket notification:
Transducer Model Number
C15/4-2, 4.0 - 2.0 MHz Curved Array L25/10-5, 10.0-5.0 MHz Linear Array C11/7-4, 7.0 - 4.0 MHz Curved Array ICT/7-4, 7.0 - 4.0 MHz Intracavitary Transducer L38/10-5, 10.0-5.0 MHz Linear Array
7
C60/5-2, 5.0 - 2.0 MHz Curved Array · L52/10-5, 10.0 -5.0 MHz Linear Array
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device. vou submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30. 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
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".
8
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
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 Hand-Carried Ultrasound System (PowerSeries)
Intended Use:
Diagnostic ultrasound imaging or fluid flow measurement 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 | P | P | P | B+M; B+PWD | Note 1 | ||
Abdominal | P | P | P | P | B+M; B+PWD; | |||
B+CWD | Note 1 | |||||||
Intra-operative (Abdominal | ||||||||
organs and vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | |||
Pediatric | P | P | P | P | B+M; B+PWD; | |||
B+CWD | Note 1 | |||||||
Small Organ (breast, | ||||||||
thyroid, testicles.) | P | P | P | B+M; B+PWD | Note 1 | |||
Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
Adult Cephalic | ||||||||
Trans-rectal | P | P | P | B+M; B+PWD | Note 1 | |||
Trans-vaginal | P | P | P | B+M; B+PWD | Note 1 | |||
Trans-urethral | ||||||||
Trans-esoph. (non-Card.) | ||||||||
Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-luminal | ||||||||
Other (spec.) | ||||||||
Cardiac | Cardiac Adult | P | P | P | P | B+M; B+PWD; | ||
B+CWD | Note 1 | |||||||
Cardiac Pediatric | P | P | P | P | B+M; B+PWD; | |||
B+CWD | Note 1 | |||||||
Trans-esophageal (card.) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | ||
Other (spec.) |
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other indludes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Tirectional Color Power Doppler, 3-D Integing, Tissue Harmonic Imaging for guidance of biopsy previously cleared through : 10(k) K014116. Included with this 510k are imaging to assist in the placement of needles and calheters in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
RA
10
SonoSite Hand-Carried Ultrasound System (PowerSeries) System:
Transducer:
Diagnostic ultrasound imaging or fluid flow measurement 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 | |||||||
Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
Abdominal | P | P | P | P | B+M; B+PWD; | |||
B+CWD | Note 1 | |||||||
Intra-operative (Abdominal | ||||||||
organs and vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
Small Organ (breast, | ||||||||
thyroid, testicles.) | P | P | P | B+M; B+PWD | Note 1 | |||
Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Card.) | ||||||||
Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (spec.) | ||||||||
Cardiac Adult | P | P | P | P | B+M; B+PWD; | |||
B+CWD | Note 1 | |||||||
Cardiac | Cardiac Pediatric | P | P | P | P | B+M; B+PWD; | ||
B+CWD | Note 1 | |||||||
Trans-esophageal (card.) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | 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 Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Note 1. Other holded Golor Power Joseph Joseph Joseph for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
Indications for Use
Division of Reproductive, Abdominat,
and Radiological Devices K021628
510(k) Number
11
SonoSite Hand-Carried Ultrasound System (PowerSeries) System:
L25/10-5 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 | Specific | B | M | PWD | CWD | Color | ||
Doppler | Combined | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
(Track I only) | (Tracks I & III) | |||||||
Ophthalmic | Ophthalmic | |||||||
Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
Abdominal | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-operative (Abdominal | ||||||||
organs and vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | ||
Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
Small Organ (breast, | ||||||||
thyroid, testicles.) | P | P | P | B+M; B+PWD | Note 1 | |||
Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Card.) | ||||||||
Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-luminal | ||||||||
Other (spec.) | ||||||||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | P | P | P | B+M; B+PWD | Note 1 | ||
Trans-esophageal (card.) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | 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 Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and cathers in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off Division of Reproductive, and Radiological Devices 510(k) Number
Indications for Use
12
SonoSite Hand-Carried Ultrasound System (PowerSeries)
C11/7-4 7.0 - 4.0 MHz Curved Array Transducer:
System:
Diagnostic ultrasound imaging or fluid flow analysis of the human body Intended Use: 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 | P | P | P | P | B+M; B+PWD; | ||||
B+CWD | Note 1 | ||||||||
Intra-operative (Abdominal | |||||||||
organs and vascular) | B+M | Note 1 | |||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | |||||||||
& Other | Laparoscopic | ||||||||
Pediatric | P | P | P | P | B+M; B+PWD; | ||||
B+CWD | Note 1 | ||||||||
Small Organ (breast, | |||||||||
thyroid, testicles.) | |||||||||
Neonatal Cephalic | P | P | P | B+M; B+PWD | 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 | P | P | P | P | B+M; B+PWD: | |||
B+CWD | Note 1 | ||||||||
Trans-esophageal (card.) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | 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 PowerMap™ Directional Note 1. Other Thouse, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K014116. Induded with this 510k are imaging to assist in the placement of needles and catheters in vascular of other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive,
and Radiological Devices
510(k) Number _
13
SonoSite Hand-Carried Ultrasound System (PowerSeries) System: ICT/7-4 7.0-4.0 MHz Intracavitary Transducer Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler | Combined | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
Abdominal | ||||||||
Intra-operative (Abdominal | ||||||||
organs and vascular) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (breast, | ||||||||
thyroid, testicles.) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | P | P | P | B+M; B+PWD | Note 1 | |||
Trans-vaginal | P | P | P | B+M; B+PWD | 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 Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through Ook) 1 ower Bopper, o Dimaging to assist in the placement of needles and catherers in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
and Radiological Device 510(k) Number
Indications for Use
14
SonoSite Hand-Carried Ultrasound System (PowerSeries) System: Transducer: L38/10-5 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 | Ophthalmic | |||||||
Fetal Imaging | |||||||||
& Other | Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
Abdominal | P | P | P | B+M; B+PWD | Note 1 | ||||
Intra-operative (Abdominal | |||||||||
organs and vascular) | P | P | P | B+M; B+PWD | Note 1 | ||||
Intra-operative (Neuro.) | |||||||||
Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | ||||
Pediatric | P | P | P | B+M; B+PWD | Note 1 | ||||
Small Organ (breast, | |||||||||
thyroid, testicles.) | P | P | P | B+M; B+PWD | Note 1 | ||||
Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | ||||
Adult Cephalic | |||||||||
Trans-rectal | |||||||||
Trans-vaginal | |||||||||
Trans-urethral | |||||||||
Trans-esoph. (non-Card.) | |||||||||
Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | ||||
Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | ||||
Intra-luminal | |||||||||
Other (spec.) | |||||||||
Cardiac | Cardiac Adult | ||||||||
Cardiac Pediatric | P | P | P | B+M; B+PWD | Note 1 | ||||
Trans-esophageal (card.) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | 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 Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Noter friddes Ooks T The Dopper John Citraging, and Imaging for guidance of biopsy proviously clared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and cathers in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number _
Indications for Use
15
SonoSite Hand-Carried Ultrasound System (PowerSeries) 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 Imaging | ||||||||
& Other | Fetal | P | P | P | B+M; B+PWD | Note 1 | ||
Abdominal | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-operative (Abdominal | ||||||||
organs and vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | ||||||||
Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
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 | P | P | P | B+M; B+PWD | Note 1 | ||
Cardiac Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
Trans-esophageal (card.) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Now Your Timelator Over Pirson Tissue Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and catherers in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
and Radiological Devices 510(k) Number
Section 4.3, page 12
Indications for Use
16
SonoSite Hand-Carried Ultrasound System (PowerSeries) System:
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 | P | P | P | B+M; B+PWD | Note 1 | ||
Abdominal | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-operative (Abdominal | ||||||||
organs and vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | |||
Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
Small Organ (breast, | ||||||||
thyroid, testicles.) | P | P | P | B+M; B+PWD | Note 1 | |||
Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Card.) | ||||||||
Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | |||
Intra-luminal | ||||||||
Other (spec.) | ||||||||
Cardiac | Cardiac Adult | |||||||
Cardiac Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
Trans-esophageal (card.) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | 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 Coverty of the until Note 1. Only 1. Ower Roudes Ook 1 Ower Bopping, and imaging for guidance of biopsy proviously cleared through Occar rower opplied on this 510k are imaging to assist in the placement of needles and catherers in vascular or other anatomical structures.
Prescription Use (Per 21 CFR 801.109)
Nancy C hogdon
(Division Sian-O Division of Reproductiv and Radiological Device 510(k) Number
Section 4.3, page 13
Indications for Use