(259 days)
Not Found.
No
The document describes a standard Transcranial Doppler system and does not mention any AI or ML capabilities in the device description, intended use, or performance testing sections.
No
The device is described as measuring blood flow velocities and hemodynamic parameters, which are diagnostic functions, not therapeutic.
Yes
The device is designed to measure blood flow velocities and other hemodynamic parameters, which are used to assess the health of blood vessels. This information can then be used by a healthcare professional to diagnose medical conditions related to blood flow. The "Indications for Use" section also states that it is a "medical ultrasound device for measuring the blood flow velocities...consistent with the FDA Ultrasound System and Transducer Indication for Use forms".
No
The device description explicitly states that the Sonara system includes integrated hardware components such as a 15" touch screen color LCD display, integrated PC board, and hard disk. The Sonara/tek version also utilizes a personal computer via a USB connection and supports ultrasound probes. These are all hardware components, not solely software.
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 taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that the Sonara and Sonara/tek devices are medical ultrasound devices that measure blood flow velocities noninvasively. This means they are used externally on the body and do not require taking samples from the patient.
- Intended Use: The intended use is to measure blood flow velocities in arteries and veins, which is a physiological measurement performed directly on the patient.
Therefore, the function and intended use of this device fall under the category of medical devices used for physiological measurement, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).
Sonara System and Sonara/tek System:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic (PWD), Intraoperative (PWD), Pediatric (PWD), Neonatal Cephalic (PWD), Adult Cephalic (PWD), Peripheral Vascular (PWD, CWD).
Additional Comments: The Sonara device can be used during surgery to support Transcranial Doppler Monitoring, Carotid Monitoring, Emboli Detection (HITS). No associated transducer probes are applied invasively.
2 MHz PW Hand-Held Transducer, 2 MHz PW Monitoring Transducer, 4 MHz Transducer, 8 MHz Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic (M), Intraoperative (M), Pediatric (M), Neonatal Cephalic (M), Adult Cephalic (M), Peripheral Vascular (M).
Additional Comments: Intraoperative: Noninvasive use during surgery to support Transcranial Doppler Monitoring, Carotid Monitoring, Emboli Detection (HITS).
4 MHz Transducer:
Clinical Application: Peripheral Vascular (PWD, CWD).
Additional Comments: Intraoperative: Use during surgical procedures to support noninvasive extracranial monitoring.
8 MHz Transducer:
Clinical Application: Peripheral Vascular (M, CWD).
Additional Comments: Intraoperative: Use during surgical procedures to support noninvasive extracranial monitoring.
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX
Device Description
The Sonara device is a Transcranial and peripheral vascular Doppler system, which is designed to measure blood flow velocities and other hemodynamic parameters in a non-invasive manner, in intracranial, extracranial and peripheral blood vessels. The Sonara system includes an integrated 15" touch screen color LCD display, integrated PC board and hard disk for data management and display. The Sonara/tek is the same device, utilizing a personal computer for its operation (via USB connection). The TCD system supports 2MHz, 4MHz and 8MHz ultrasound probe frequencies, either in a unilateral or bilateral configuration. For monitoring purpose, a special 2MHz monitoring probe (which fits into a headset) is provided. Online and Offline modes of operation are available. The system also includes a remote control and footswitch as accessories.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Ultrasound
Anatomical Site
Intracranial, extracranial and peripheral blood vessels, Ophthalmic, Abdominal, Intraoperative, Pediatric, Neonatal Cephalic, Adult Cephalic, Peripheral Vascular.
Indicated Patient Age Range
Not Found.
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)
The Sonara and Sonara/tek Transcranial and vascular Doppler devices have been subjected to extensive safety, performance testing, and validation before release. Final testing of the Sonara device included various performance tests designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards.
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.
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
NOV - 3 2006
510(K) SUMMARY
SONARA TCD SYSTEM (INCLUDING SONARA AND SONARA/TEK)
510(k) Number: K060421
| Applicant's Name: | VIASYS Healthcare, Inc.
227 Washington St., Suite 200
Conshohocken, PA 19428 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor Contact: | Mr. Glen Hermanson
Global Manager, Quality Engineering
VIASYS NeuroCare, Inc.
5225 Verona Road
Madison, WI 53711
Phone: 608 441-2065
Fax: 608 441-2007 |
| Date Prepared: | September 29, 2006 |
| Trade Name: | Sonara and Sonara/tek Transcranial Doppler (TCD) System |
| Classification Name: | CFR Classification section 892.1550 (Product code IYN); CFR
Classification section 892.1570 (Product code ITX) |
| Classification: | Class II medical Device |
| Predicate Device: | The Sonara and Sonar/tek TCD devices are comparable to the following
predicate devices: |
| | - Doppler-Box (K051085) manufactured by Compumedics Gmbh
(DWL). Doppler-Box is a Transcranial Doppler Ultrasound device,
providing similar data to the Sonara/tek device. |
| | - TCD 100M (K002533) manufactured by Spencer Technologies. TCD
100M is a Transcranial Doppler Ultrasound device, providing similar
data to the Sonara device. |
| | - TC8080 Pioneer /Companion III (K053648) manufactured by VIASYS
HealthCare, Inc., Neurocare Group.
The TC8080 Pioneer /
Companion III are TCD devices with equivalent indications for use. |
| Device Description: | The Sonara device is a Transcranial and peripheral vascular Doppler
system, which is designed to measure blood flow velocities and other
hemodynamic parameters in a non-invasive manner, in intracranial,
extracranial and peripheral blood vessels.
The Sonara system includes an integrated 15" touch screen color LCD
display, integrated PC board and hard disk for data management and |
| Performance Standards: | None.
The design of the Sonara and Sonara/tek Transcranial Doppler (TCD)
devices conforms to the following voluntary standards:
IEC/EN-60601-1: Medical Electrical Equipment; Part 1: General
Requirements for Safety. Second edition (1990), including amendments
#1(1993), #2(1995), #13(1996).
IEC/EN 60601-1-2: Medical Electrical Equipment; Part 1-2: Collateral
Standard: Electromagnetic Compatibility- Requirements and Tests
(2001)
IEC/EN 60601-2-37: Medical Electrical Equipment; Part 2: Particular
Requirements for the Safety of Ultrasonic Medical Diagnostic and
Monitoring Equipment (2001) |
| Acoustic Output: | Acoustic output reporting for the Sonara devices was carried in
compliance with "Information for manufacturers seeking marketing
clearance of diagnostic ultrasound systems and transducers", September
30, 1997 (FDA Ultrasound Guidance (1997), Table 6-3, Page 6-9. |
| Test Data: | The Sonara and Sonara/tek Transcranial and vascular Doppler devices
have been subjected to extensive safety, performance testing, and
validation before release. Final testing of the Sonara device included
various performance tests designed to ensure that the device met all its
functional specifications. Tests have been performed to ensure the
device complies with industry and safety standards. |
| Substantial Equivalence: | The Sonara and Sonara/tek TCD are similar to currently distributed
pulsed Doppler Ultrasound systems with 2MHz, 4MHz and 8MHz
transducers intended for transcranial and peripheral Doppler
applications. Maximum acoustic output levels are below pre-amendment
levels for acoustic intensity for this application, and for Mechanical
Index for all applications. Power levels are displayed at all times during
scanning. A standard spectrum display is shown in both viewing |
1
display. The Sonara/tek is the same device, utilizing a personal computer for its opcration (via USB connection). The TCD system supports 2MHz, 4MHz and 8MHz ultrasound probe frequencies, either in a unilateral or bilateral configuration. For monitoring purpose, a special 2MHz monitoring probe (which fits into a headset) is provided. Online and Offline modes of operation are available. The system also includes a remote control and footswitch as accessories.
Intended Use / Indication for Use: The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).
Performance Standards: None
2
| formats. The device includes an M-mode image. All of the above features are similar to these features in the predicate devices. | |
|---|---|
| Conclusions: | The conclusions drawn from the above Performance Testing and comparison to Predicate devices is that the Sonara and Sonara/tek Transcranial and peripheral vascular Doppler device and transducers are substantially equivalent in safety and efficacy to the predicate devices listed above. |
:
:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
VIASYS Healthcare, Inc., NeuroCare Group % Mr. Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane MADISON WI 53711
Re: K060421
Trade Name: Sonara and Sonara/tek Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN and ITX Dated: October 6, 2006 Received: October 10, 2006
Dear Mr. Syring:
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 Sonara and Sonara/tek Systems, as described in your premarket notification:
Transducer Model Number
2 MHz PW Hand-Held Transducer 2 MHz PW Monitoring Transducer 4 MHz Transducer 8 MHz Transducer
Image /page/3/Picture/14 description: The image is a circular logo or emblem. The text "1906-2006" is at the top, and the letters "FDA" are in the center. The word "Centennial" is below the letters. There are three stars below the word "Centennial". The text "Dedicated to Protecting and Promoting Your Health" surrounds the circle.
Protecting and Promoting Public Health
4
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
5
If you have any questions regarding the content of this letter, please contact Dr. Ewa Czerska at (240) 276-3666 .
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)
6
Sonara System
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
an her marcanent of the Sonara device can be used during surgery to support Transcranial Doppler
Additional Comments:
Monitoring, Carotid Monitoring, Emboli Detection (HITS).
No associated transducer probes are applied invasively.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510k) Number _
7
Sonara/tek System
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
Additional Comments: The Sonara/tek device can be used during surgery to support Transcranial Doppler
Monitoring, Carotid Monitoring, Emboli Detection (HITS).
No associated transducer probes are applied invasively.
Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number __
$$\varepsilon \text{-3}$$
Page 210
8
Appendix F
2 MHz PW Hand-Held Transducer
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
Intraoperative: Noninvasive use during surgery to support Transcranial Doppler Additional Comments:_
Monitoring, Carotid Monitoring, Emboli Detection (HITS).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division S Division of Reproductive, Abd and Radiological Devices F-3 10(k) Number
Page 211
9
Appendix F
2 MHz PW Monitoring Transducer
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pedialric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
Additional Comments: Intraoperative: Noninvasive use during surgery to support Transcranial Doppler
Monitoring, Carotid Monitoring, Emboli Detection (HITS)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Danay Shrodon
Division Slar of Reproductive. liological Devices 510(k) Numbe --3
10
4 MHz Transducer
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_
Prescription Use (Per 21 CFR 801.109)
Intraoperative: Use during surgical procedures to support noninvasive extracranial monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broadon
Division S Division of Active, Abdominal, and Radiological Devices 510/k) Number
F-3
Page 213
11
8 MHz Transducer
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Intraoperative: Use during surgical procedures to support noninvasive extracranial monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancyc brogdon
(Division Sign-Off) Division of Reproductive, Al ominal and Radiological Device 510(k) Number ....
-- Page 214
E-3