(6 days)
1001007-1, 1000000, 1961459
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 device description, intended use, or other sections. The focus is on traditional ultrasound data acquisition and display.
No
The device is described as a "diagnostic ultrasound system" and its intended use is for "Diagnostic ultrasound imaging or fluid flow analysis," indicating it is used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Furthermore, the "Device Description" section describes it as a "diagnostic ultrasound system" and mentions that it provides "information used for clinical diagnostic purposes".
No
The device description explicitly states it is a "SonoSite Hand-Carried Ultrasound System" and mentions hardware components like transducers, a monitor, and an ECG cable assembly. It is a software-controlled hardware system, not software-only.
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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the SonoSite Hand-Carried Ultrasound System uses ultrasound waves to image the inside of the human body and analyze fluid flow within the body. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use lists various anatomical sites and applications for imaging and analysis within the human body.
- Device Description: The description focuses on how the system acquires and processes ultrasound data from within the body.
Therefore, the function and intended use of this device fall under the category of medical imaging equipment used for in vivo diagnosis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended uses of the SonoSite Hand-Carried Ultrasound System, as defined by FDA guidance documents, are:
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
Typical examinations performed using the SonoSite Hand-Carried Ultrasound System are:
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 Increasonient 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, patency of the broad be used to assess the presence and extent of some diseases and injuries.
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. The ECG is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac myths and is not designed for long term cardiac rhythm monitoring.
Neonates: Abdomen, cranium, pelvis and heart in neonates that weigh less than 1500 grams or are less than 32 weeks gestation: This system transmits ultrasound energy into the cranium, abdomen, pelvis soft tissue or heart of patients to obtain 2D, CPD, PowerMap 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: informer online online shunt placement and dilated ventricles; Abdominal organs - renal disease, gallbladder disease; Pelvis - ovarian / brominal organe - from 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, to actor 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, deep veins in the arms and legs, great vessels in the abdomen, and peripheral line access, and interventional radiology purposes.
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 is a highly portable, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, PowerMap™ Directional Color Power Doppler, or in a combination of modes.
The System has an electrocardiography (ECG) display feature and supports a 3lead ECG cable assembly to collect data. The SonoSite Hand-Carried Ultrasound System also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes.
The SonoSite Hand-Carried 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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), 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 (breast, thyroid, superficial soft tissue, shoulder joints, wrist), pelvis, thorax, cranium, heart, prostate.
Indicated Patient Age Range
Adult, pediatric, neonates (less than 1500 grams or less than 32 weeks gestation).
Intended User / Care Setting
Clinician (implied)
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.
1001007-1, 1000000, 1961459
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
DEC 2 0 2001
SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904 USA
Telephone: 1.425.951.1200 Facsimile: 1.425.951.1201
510(K) Summary Of Safety And Effectiveness
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
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: November 19 2001
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 (subject to change)
Image /page/0/Picture/16 description: The image shows the SonoSite logo. The logo consists of a black square with a white curved shape inside, followed by the word "SonoSite" in a bold, sans-serif font. Below "SonoSite" is the tagline "Imagine What You Can Do" in a smaller font. The logo is simple and modern, and the tagline is aspirational.
1
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 |
Identification of the predicate or legally marketed device: 3)
SonoSite, Inc. believes that System described in this Submission is substantially equivalent to a combination of the SonoSite Hand-Carried Ultrasound System (K010374), (K003399) and the Advanced Technology Laboratories (ATL) HD1 (1001007-1), (1000000) (1961459). Where applicable, this new Submission references sections of K010374 and K003399 to signify that the sections remain the same as for those predicate devices.
4) Device Description:
The SonoSite Hand-Carried Ultrasound System is a highly portable, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, PowerMap™ Directional Color Power Doppler, or in a combination of modes.
The System has an electrocardiography (ECG) display feature and supports a 3lead ECG cable assembly to collect data. The SonoSite Hand-Carried Ultrasound System also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes.
The SonoSite Hand-Carried 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 |
2
The SonoSite Hand-Carried Ultrasound System is designed to comply with the standards listed below.
| EN 60601-1:1997 | IEC 61000-4-2:1999 |
|---|---|
| EN 60601-1-1:1993 | IEC 61000-4-3:1997 |
| EN 60601-2-25:1996 | IEC 61000-4-4:1995 |
| EN 60601-1-2:1998 | IEC 61000-4-5:1999 |
| UL 2601-1:1999 | ISO 10993 |
| CAN/CSA C22.2, No. 601.1:1998 | ISO 9001 |
| CEI/IEC 61157:1992 | EN 46001 |
| RTCA/D0160D: 1997 | 21 CFR 820 |
| CISPR11:1997 | ANSI/AAMI EC53:1995 except for |
| sections 4.4 and 4.5.9 | |
| JIS-T-100X-Series | Acoustic Output Measurement and |
| Labeling Standard for Diagnostic | |
| Ultrasound Equipment, American | |
| Institute of Ultrasound in Medicine, | |
| 1993 | |
| Standard for Real-Time Display of | |
| Thermal and Mechanical Acoustic Output | |
| Indices on Diagnostic Ultrasound | |
| Equipment, American Institute of | |
| Ultrasound in Medicine, 1998 | European Active Medical Device |
| Directive (93/42/EEC) | |
| Acoustic Output Measurement Standard | |
| for Diagnostic Ultrasound Equipment, | |
| NEMA UD2-1998 |
Intended Use: 5)
The intended uses of the SonoSite Hand-Carried Ultrasound System, as defined by FDA guidance documents, are:
| 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
Typical examinations performed using the SonoSite Hand-Carried Ultrasound System are:
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 Increasonient 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, patricity of the broad be used to assess the presence and extent of some diseases and injuries.
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. The ECG is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac mythms and is not designed for long term cardiac rhythm monitoring.
Neonates:
Abdomen, cranium, pelvis and heart in neonates that weigh less than 1500 grams or are less than 32 weeks gestation: This system transmits ultrasound energy into the cranium, abdomen, pelvis soft tissue or heart of patients to obtain 2D, CPD, PowerMap DCPD, M-mode, or PW and CW Doppler images. These images will be used to assess the presence and extent of some diseases or
4
injuries. Some examples of the pathology that ultrasound is used for include: informer online online shunt placement and dilated ventricles; Abdominal organs - renal disease, gallbladder disease; Pelvis - ovarian / brominal organe - from 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, to actor 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, deep veins in the arms and legs, great vessels in the abdomen, and peripheral line access, and interventional radiology purposes.
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 material in the body. Sound waves are reflected back to the transducer and waves into the body. Sound ithat are processed and displayed as 2D or M-Mode images. Doppler shift caused by blood flow is displayed as Color Flow, or Mode Images: Doppier Chilis device (2D, PW Doppler, CW Doppler, CW Doppler, as Spectrum andryoler The nower Map™ Directional Color Power Doppler) are the Ooler Forel Boppion, and be 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 or potential thermal information so users may moderate the system's program provided additional morith 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 Department of Health & Human Services - USA. The logo is a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has three stripes on its wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
SonoSite, Inc. % Mr. Mark Job 510(k) Program Manager TÜV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K014116
Trade Name: SonoSite Hand-Carried Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulatory Class: II Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: 90 ITX Dated: December 12, 2001 Received: December 14, 2001
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:
7
Transducer Model Number
| L25/10-5 | 10.0-5.0 MHz | Linear Array |
|---|---|---|
| L52/10-5 | 10.0-5.0 MHz | Linear Array |
| C11/7-4 | 7.0-4.0 MHz | Curved Array |
| C15/4-2 | 4.0-2.0 MHz | Curved Array |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
8
Page 3 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please If you desire appearle at (301) 594-4591. Additionally, for questions on the comact the Office of Compilance at (vice, please contact the Office of Compliance at (301) 594promotion and as verate the regulation entitled, "Misbranding by reference to premarket 4057. Also, production and 807.97). Other general information on your responsibilities under the notification (2) OFF Part 80777). One geall 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 A. Jepson
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
9
K
SonoSite Hand-Carried Ultrasound System System:
DEC 2 0 2001
Diagnostic ultrasound imaging or fluid flow analysis of the human Intended Use: body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
| Abdominal | P | P | P | N | 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 | P | P | P | B+M; B+PWD | Note 1 | ||
| Pediatric | P | P | P | N | 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 Adult | P | P | P | N | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| Cardiac | Cardiac Pediatric | P | P | P | N | 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 Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K010374.
Prescription Use (Per 21 CFR 801.109)
Torin C. Ligon
Section 4.3, page 7
10
SonoSite Hand-Carried Ultrasound System System:
L25/10-5 10.0-5.0 MHz Linear Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human Intended Use: body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | N | N | N | B+M; B+PWD | Note 1 | ||
| Abdominal | N | N | N | B+M; B+PWD | Note 1 | |||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | N | N | N | B+M; B+PWD | Note 1 | |||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | N | N | N | B+M; B+PWD | Note 1 | |||
| Pediatric | N | N | N | B+M; B+PWD | Note 1 | |||
| 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 | ||||||||
| 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.) | N | N | N | B+M; B+PWD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | N | N | N | B+M; B+PWD | Note 1 | |||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | 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 blopsy previously cleared through 510(k) K010374.
Prescription Use (Per 21 CFR 801.109)
David A. Leger
(Division Sign-Off) Division of Reprodu and Radiological Do 510(k) Number
11
SonoSite Hand-Carried Ultrasound System System:
L52/10-5 10.0-5.0 MHz Linear Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body Intended Use: as follows
| Clinical Application | | Mode of Operation | | | | | | Other
(Spec.) |
|---------------------------|----------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal | N | N | N | | | B+M; B+PWD | Note 1 |
| | Abdominal | N | N | N | | | B+M; B+PWD | Note 1 |
| | Intra-operative (Abdominal
organs and vascular) | N | N | N | | | B+M; B+PWD | Note 1 |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | N | N | N | | | B+M; B+PWD | Note 1 |
| | Pediatric | N | N | N | | | B+M; B+PWD | Note 1 |
| | 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 | | | | | | | |
| | 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.) | N | N | N | | | B+M; B+PWD | Note 1 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | N | N | N | | | B+M; B+PWD | Note 1 |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | N | N | N | | | 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. Only 1. One hildled Ook Pontinent in a maging for guidance of biopsy previously cleared through 510(k) K010374.
Prescription Use (Per 21 CFR 801.109)
Division Sign-Off
(Division Sign-Off) Division of Reproductive, Al and Radiological Device 510(k) Number .
12
SonoSite Hand-Carried Ultrasound System System:
C11/7-4 7.0 - 4.0 MHz Curved Array Transducer:
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 Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P | P | P | N | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | B+M | Note 1 | ||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | N | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | P | P | P | B+M; B+PWD | Note 1 | |||
| 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 | |||||||
| Cardiac Pediatric | P | P | P | N | 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 Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K010374.
Prescription Use (Per 21 CFR 801.109)
David A. Lequien
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number
13
SonoSite Hand-Carried Ultrasound System System:
C15/4-2 4.0 – 2.0 MHz Curved Array Transducer:
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 | P | P | P | B+M; B+PWD | Note 1 | |||
| Abdominal | P | P | P | N | 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 | N | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| Cardiac | Cardiac Pediatric | P | P | P | N | B+M; B+PWD; | ||
| B+CWD | Note 1 | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | ||
| 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 510(k) K010374.
Prescription Use (Per 21 CFR 801.109)
Elaral U. Legarra
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number