SONIX ULTRASOUND SCANNER
Device Facts
| Record ID | K061827 |
|---|---|
| Device Name | SONIX ULTRASOUND SCANNER |
| Applicant | Ultrasonix Medical Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Aug 4, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Sonix Ultrasound Scanners is intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. In addition, the system can be used by a qualified physician in Emergency Medicine to assist in the decision process for triaging a patient. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal, interventional.
Device Story
Sonix Ultrasound Scanner is a mobile, software-controlled diagnostic ultrasound system. Inputs: ultrasound signals from linear, convex, microconvex, or phased array transducers. Operation: piezoelectric transducers transmit sound waves into body; reflected waves converted to electrical signals; programmable beam-forming architecture processes signals into 2D, M-mode, Pulsed/CW Doppler, Color Flow, and Amplitude Doppler images. Features: ECG display, cine review, image zoom, labeling, biopsy guidance, measurements, and DICOM storage. Used in clinics/hospitals by physicians for soft tissue diagnosis, fetal biometry, and emergency triage. Output: real-time images and biometric data displayed on monitor; assists clinicians in diagnostic decision-making and interventional guidance. Benefits: non-invasive visualization of internal structures and blood flow.
Clinical Evidence
Bench testing only. The device complies with IEC 60601-1, IEC 60601-2-37, and NEMA UD-3 standards for acoustic output and safety. Acoustic output limits (ISPTA 720mW/cm2, MI 1.9) are within established guidelines for Track 3 ultrasound devices.
Technological Characteristics
Mobile ultrasound system; piezoelectric transducers (linear, convex, microconvex, phased array); 2-15MHz frequency range. Programmable beam-forming architecture using reconfigurable building blocks. Connectivity: DICOM module. Safety standards: EN 60601-1, UL 2601-1, C22-2 No 601-1, IEC 60601-2-37. Biocompatible patient contact materials. Biopsy accessories: polymeric brackets and single-use needle guides.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in obstetrics, gynecology, general radiology, cardiac, and emergency medicine. Patient population includes pediatric and adult patients. Clinical applications include abdominal, small parts, peripheral vascular, MSK, cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, fetal, cardiac, transcranial, transesophageal, and interventional procedures.
Regulatory Classification
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.
Predicate Devices
- Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630)
- ATL HDI 5000 System (K002003)
- Acuson Sequoia (K973767)
Related Devices
- K093462 — SONIX ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Nov 20, 2009
- K042326 — ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Sep 16, 2004
- K031552 — MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS · Medison America, Inc. · May 30, 2003
- K112726 — SONIX ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Sep 27, 2011
- K113663 — SONIXTABLET ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Jan 25, 2012
Submission Summary (Full Text)
{0}------------------------------------------------
## KO61827
## 510 (k) Summary for the SONIX Ultrasound Scanner
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) summary.
#### 1.0 Submitter Information
#### 1.1 Submitter
Ultrasonix Medical Corporation 301-3480 Gilmore Way Burnaby, British Columbia Canada V5G 4Y1 (t) 604-437-9500 (f) 604-437-9502
#### 1.2 Contact
lulia Nuca, QA Manager (t) 604-437-9500 x 105 (f) 604-437-9502 (e) iulia@ultrasonix.com
#### 1.3 Date Prepared
June 26, 2006
#### 2.0 Device Name
#### 2.1 Common Name
Ultrasound Imaging System
#### 2.2 Proprietary Name
Sonix Ultrasound Scanner
#### 2.3 Classification Name
| | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
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## 2.4 Classification
Class Ila
## 2.5 Predicate Device:
Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767)
## 2.6 Reason for submission:
## Clearance request for:
- UPS .
- Wireless .
- Barcode reader ●
- Data Management for ultrasound QA .
- The intended use of biopsy: .
- Transducers: L9-4/38 L14-5/38 L14-5W/60 C5-2/ 60 EC9-5/10 C7-3/50
## Name change request
N/A
## New product clearance
N/A
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## 2.7 Device description
The Sonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images.
The system has an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.
The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.
The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands. The needle guides are single use (disposable).
| Frequency Range | 2-15MHz |
|------------------|-------------------------------------------------------------------|
| Transducer types | Linear array<br>Curved array<br>Intracavity array<br>Phased array |
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The Sonix Ultrasound Scanner is designed to comply with the following standards:
| EN 60601-1 | European Norm, Medical Electrical Equipment |
|----------------|--------------------------------------------------------------------------------------|
| UL 2601-1 | Underwriters Laboratories Standards, Medical<br>Electrical Equipment |
| C22-2 No 601-1 | Canadian Standards Association, Medical<br>Electrical Equipment |
| EM 60601-1-1-2 | European Norm, Collateral Standard,<br>Electromagnetic Compatibility |
| IEC 60601-2-37 | Particular requirements for the safety of<br>ultrasonic medical diagnostic equipment |
| AIUM | Acoustic Output Labeling Standard for Diagnostic<br>Ultrasound Equipment - Jan 1998 |
| AIUM | Standard for Real-Time Display of Thermal and<br>Mechanical Acoustic Output Indices |
## 3.0 Summary of Intended Uses
The Sonix Ultrasound Scanners is intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. In addition, the system can be used by a qualified physician in Emergency Medicine to assist in the decision process for triaging a patient.
The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal, interventional.
## 4.0 Comparison to Predicate Device
The Sonix Ultrasound Scanner is substantially equivalent to the predicate devices with respect to intended use/indications for use, principles of operation and technological characteristics.
## 5.0 Technological characteristics
The technological characteristics are substantially similar to that of the predicates. The device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sounds waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D or M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) are the same as the predicate devices identified in item 2.5. Transducer patient contact materials are biocompatible.
The beam forming architecture is very similar to that of the predicate devices. The receiving and processing hardware is similar but innovative in that it is a programmable system made of 2 building blocks, which can be reconfigured to operate the system in any imaging mode.
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The parameters used to adjust image quality are the same as that seen in the predicates. This includes the use of TGC gain sliders, depth control and angling, among others.
#### 6.0 Safety considerations
As track 3 ultrasound device, the Sonix Ultrasound Scanner is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by the National Electrical Manufacturers Association as UD-3.
With respect to limits on acoustic outputs, the Sonix Ultrasound Scanner complies with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance.
With regard to general safety, the Sonix Ultrasound Scanner is designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601-2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.
The devices' acoustic output limits are:
| ISPTA (d) | 720mW/cm2 |
|-----------------------|----------------------|
| TIS/TIB/TIC | 0.1 - 4.0 (Range) |
| Mechanical Index (MI) | 1.9 (Maximum) |
| ISPPA (d) | 0 - 700W/cm2 (Range) |
The limits are the same as predicate Track 3 devices.
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Image /page/5/Picture/1 description: The image shows a logo for the Department of Health and Human Services (USA). The logo features a stylized abstract design resembling a human figure or a symbol of care and support. The text "MAN SERVICES USA" is arranged in a circular fashion around the top of the design, and the word "DEPARTMENT" is placed at the bottom.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG - 4 2006
Ms. Lulia Nuca Quality Assurance Ultrasonix Medical Corp. 301-3480 Gilmore Way Burnaby, BC, V5G 4Y1 CANADA
Re: K061827
Trade Name: Sonix Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 26, 2006 Received: June 28, 2006
Dear Ms. Nuca:
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 Sonix Ultrasound Scanner, as described in your premarket notification:
Image /page/5/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a bold, stylized font at the center. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by text that reads "Dedicated to consumer protection in the service of public health".
oting Public 9.
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#### Transducer Model Number
C5-2/40 convex_1/5MHz 40mm radius C5-2/60 convex 1/5MHz 60mm radius L14-5/38 linear 5/12MHz 38mm L14-5W/60 linear 5/12MHz 60mm L9-4/38 linear 4/9MHz 38mm PA4-2/20 phased array 2/4MHz PA7-4 phased array 4/7MHz EC9-5/10 microconvex endocavity 5/9MHz 10mm radius T7-4 TEE phased array 4/7MHz 4DC7-3/40 motorized convex 3/7MHz 40mm radius C7-3/50 convex 3/7MHz 50mm radius BPSL9-5/55/10 biplane endocavity 5/9MHz IOT9-5/40 convex 4/7MHz 40mm radius intraoperational
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.
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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
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.
Sincerely vours.
Daniel A. Lepore
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Health
Enclosure(s)
{8}------------------------------------------------
David R. Syverson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. Kloer
K061827
Sonix Ultrasound Scanner
Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Abdominal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Intraoperative Neurological | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Pediatric | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Neonatal Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Adult Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Cardiac | | P | P | P | P | P | P | P | P (*1) | P (*2) |
| Transesophageal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Transrectal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Transvaginal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (*1) | P (*2) |
| MSK Superficial | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Other (specify) (*3) | | P | P | P | | P | P | P | P (*1) | P (*2) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
Intraoperative : abdominal organs and vascular
- 1 BM, BIPWD, BICWD, BICFMIPWD, BIAD/PWD, BIDPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, live 3D imaging, Directional Power Doppler (DPD)
- *3 Transcranial Doppler
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
{9}------------------------------------------------
Eivid h. dyon
oroductive. Abdomina
C5-2/40 convex 1/5MHz 40mm radius transducer
#### Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Abdominal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (*1) | P (*2) |
| MSK Superficial | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Daniel A. Lyons
·
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices (k) Number
C5-2/60 convex 1/5MHz 60mm radius transducer
#### Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (*1) | P (*2) | |
| Abdominal | | P | P | P | | P | P | P | P (*1) | P (*2) | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (*1) | P (*2) | |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) | |
| Leparoscopic | | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (*1) | P (*2) | |
| MSK Superficial | | P | P | P | | P | P | P | P (*1) | P (*2) | |
| Other (specify) | | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
- 1 BIM, BIPWD, BICWD, BICFMIPWD, BIAD/PWD, BIDPD/PWD, B/CFMICWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)_____
{11}------------------------------------------------
David A. Jepson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
K061827
L14-5/38 linear 5/12MHz 38mm transducer
Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (*1) | P (*2) | | |
| Abdominal | | P | P | P | | P | P | P | P (*1) | P (*2) | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (*1) | P (*2) | | |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) | | |
| Neonatal Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) | | |
| Adult Cephalic | | P | P | P | | p | P | P | P (*1) | P (*2) | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) | | |
| Leparoscopic | | | | | | | | | | | | |
| MSK Conventional | | P | b | P | | P | P | P | P (*1) | P (*2) | | |
| MSK Superficial | | P | b | P | | P | P | P | P (*1) | P (*2) | | |
| Other (specify) | | | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
- 1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DQ NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
{12}------------------------------------------------
David R. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________
K061827
L14-5W/60 linear 5/12MHz 60mm transducer
Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Abdominal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Neonatal Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Adult Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (*1) | P (*2) |
| MSK Superficial | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
- 1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
Daniel A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K06/827
K061827
r 4/9MHz 38mm transducer L9-4/38 lir
Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Abdominal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Neonatal Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Adult Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (*1) | P (*2) |
| MSK Superficial | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
- *1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{14}------------------------------------------------
David A. Severson
(Division Sign-Off Division of Reproductive, Abdominal and Radiological Devices
10(k) Number
PA4-2/20 phased array 2/4MHz transducer
#### Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Adult Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Cardiac | | P | P | P | P | P | P | P | P (*1) | P (*2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | P | P | P | | P | P | P | P (*1) | P (*2) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
## Additional Comments:
- B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/DPD/CWD .
- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
- *3 Transcranial Doppler
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{15}------------------------------------------------
Qavid A. hegemann
(Division Sign Off) Division or Reproductive, Abdominal, and Radiolor - at Devices 510(ki Nie
K06/827
PA7-4 phased array 4/7MHz transducer
## Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Adult Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Cardiac | | P | P | P | P | P | P | P | P (*1) | P (*2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | P | P | P | | P | P | P | P (*1) | P (*2) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
- B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD . 1
- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
- *3 Transcranial Doppler
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{16}------------------------------------------------
David A. Byrum
(Design Sign-Off)
of Reproductive, Abdominal, diological Devices . Number _____________________________________________________________________________________________________________________________________________________________________ 81161 Y
K061827
EC9-5/10 microconvex endocavity 5/9MHz 10mm radius transducer
#### Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Transvaginal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
* * B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2 Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{17}------------------------------------------------
David h. Ingram
ive. Abdomina
K061827
# T7-4 TEE phased array 4/7MHz transducer
Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
- 1 B/M, B/PWD, B/C/VD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{18}------------------------------------------------
K061827
roductive. Abdominal
al Deviros
4DC7-3/40 motorized convex 3/7MHz 40mm radius transducer
Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Abdominal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (*1) | P (*2) |
| MSK Superficial | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Other (specify) (*3) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
- 1 BIM, BIPWD, BICWD, BICFMIPWD, BIAD/PWD, BIDPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, Live 3D imaging, Directional Power Doppler (DPD)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 221 CFR 801.109)
{19}------------------------------------------------
David A. Leggett
of Reproductive. Abdominal. ological Devices
C7-3/50 convex 3/7MHz 50mm radius transducer
Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Abdominal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Neonatal Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Adult Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (*1) | P (*2) |
| MSK Superficial | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Other (specify) (*3) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
1 BIM, BIPWD, BICWD, BICFMIPWD, BIADIPWD, BIDPDIPWD, BICFMICWD, BIADICWD, B/DPD/CWD
*2 Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 221 CFR 801.109)
{20}------------------------------------------------
David A. Ferguson
A Reproductive, Abdominal,
ological Devices BPSL9-5/55/10 biplane endocavity 5/9MHz transducer
Diagnostic Ultrasound Indications for Use Form
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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | P | P (*1) | P (*2) | | |
| Transvaginal | | P | P | P | | P | P | P | P (*1) | P (*2) | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | | | |
| Other (specify) (*3) | | | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
#### Additional Comments:
1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD,…
