SONIX ULTRASOUND SCANNER
Device Facts
| Record ID | K112726 |
|---|---|
| Device Name | SONIX ULTRASOUND SCANNER |
| Applicant | Ultrasonix Medical Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Sep 27, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial, The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Device Story
Sonix Ultrasound Scanner is a mobile, software-controlled diagnostic ultrasound system. It acquires harmonic ultrasound echo data via various transducers (linear, convex, phased array, TEE, intracavity) and displays images in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, and Amplitude Doppler. The system includes an ECG display feature, measurement/calculation packages for anatomical structures and fetal biometry, and DICOM connectivity for storage. Operated by clinicians in clinical settings, the device provides real-time imaging and measurements to assist in clinical diagnosis. Biopsy kits (polymeric brackets and needle guides) are available as accessories. The system uses a programmable digital beamformer and reconfigurable hardware to support multiple imaging modes. Output is displayed on a flat panel; clinicians use the information adjunctively with other medical data to inform clinical decision-making and improve patient diagnostic outcomes.
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. No clinical data was required for this 510(k) submission as the device is substantially equivalent to the predicate in technological characteristics and intended use.
Technological Characteristics
Mobile ultrasound system with programmable digital beamformer. Transducers use piezoelectric materials. Supports linear, convex, microconvex, phased array, and TEE probes. Connectivity via DICOM. Complies with IEC 60601-1, IEC 60601-2-37, and NEMA UD-3. Biocompatible patient-contact materials. Software-controlled with on-screen thermal/mechanical indices.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in Ophthalmic, Abdominal, Cardiac, Intraoperative, Neurological, Fetal, Pediatric, Small Parts, Neonatal/Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal, Pelvic, Nerve block, Vascular Access, and Transcranial applications. Prescription use only.
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
- Sonix Ultrasound Scanner (K093462)
Related Devices
- K113663 — SONIXTABLET ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Jan 25, 2012
- K093462 — SONIX ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Nov 20, 2009
- K102997 — SONIXTABLET ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Dec 21, 2010
- K083095 — SONIXTOUCH ULTRASOUND SYSTEM · Ultrasonix Medical Corporation · Oct 31, 2008
- K061827 — SONIX ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Aug 4, 2006
Submission Summary (Full Text)
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# 510 (k) Summary for the Sonix Ultrasound Scanner
K112726
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 130-4311 Viking Way Richmond, British Columbia Canada V6V 2K9 (t) 604-279-8550 (f) 604-279-8559
# 1.2 Contact
Chas Yu, Quality Assurance Manager (t) 604-279-8550 x 152 (f) 604-279-8559 (e) chas.yu@ultrasonix.com
# 1.3 Date Prepared
August 26, 2011
# 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 II
# 2.5 Predicate Device:
Sonix Ultrasound Scanner (K093462) Predicate transducer for m4DC7-3/40: 4DC7-3/40 cleared under K093462 Predicate transducer for L40-8/12: L14-5/38 and HST15-8/20, both are cleared under K093462
# 2.6 Reason for submission:
# Clearance request for:
Addition of the following two transducers to Sonix Ultrasound Scanner which was previously cleared under K093462.
- m4DC7-3/40 .
- . L40-8/12
Note:
Indications for use and modes of operation of the Sonix Ultrasound Scanner previously cleared under K093462 are unchanged.
# Name change request
N/A
# New product clearance for:
N/A
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# 2.7 Device description
The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.
The system has an electrocardiography (ECG) display feature and support for 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 PW 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 quides 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 quides, sterile sheaths, ultrasound transmission gel, and bands.
| Frequency Range | 2-15MHz |
|------------------|-------------------|
| Transducer types | Linear array |
| | Curved array |
| | TEE array |
| | Intracavity array |
| | Phased array |
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The Sonix Ultrasound Scanner is designed to comply with the following standards and the system follows Track 3.
| 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 |
| EN 60601-1-2 | European Norm, Collateral Standard,<br>Electromagnetic Compatibility |
| IEC 60601-2-37 | Particular requirements for the safety of<br>ultrasonic medical diagnostic equipment |
| AIUM AOL | Acoustic Output Labeling Standard for Diagnostic<br>Ultrasound Equipment |
| AIUM RTD | Standard for Real-Time Display of Thermal and<br>Mechanical Acoustic Output Indices |
# 3.0 Summary of Intended Uses
The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial,
The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
# 4.0 Comparison to Predicate Device
The Sonix Ultrasound Scanner is substantially equivalent to the predicate devices listed below with respect to intended use/indications for use, principles of operation and technological characteristics.
The Sonix Ultrasound Scanner includes a digital beamformer that is similar in function to the predicate devices beamformer. It allows transmitting and receiving signals through the ultrasound transducers. The ultrasound transducers are similar to the ones used on predicate devices.
The backend processing is also similar to the predicate devices and yields an ultrasound image in realtime for diagnosis purposes.
# Sonix Ultrasound Scanner (K093462)
Predicate transducer for m4DC7-3/40: 4DC7-3/40 cleared under K093462 Predicate transducer for L40-8/12: L14-5/38 and HST15-8/20, both are cleared under K093462
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# 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 sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D or 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, Continuous Wave 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.
The parameters used to adjust image quality are the same as that seen in the predicates. This includes the use of TGC gain, depth control, base 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 (2004)" published by the National Electrical Manufacturers Association as UD-3.
With respect to limits on acoustic outputs, the Sonix Ultrasound Scanner complies with the quideline limits set in the September 9, 2008 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 | 0.1-6.0 (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 the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES, U.S.A." arranged around the circumference. Inside the circle is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is depicted in a simple, abstract manner with flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ultrasonix Medical Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
SEP 2 7 2011
Re: K112726
Trade/Device Name: Sonix Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Requlatory Class: II Product Code: 1YN, IYO, and ITX Dated: September 19, 2011 Received: September 20, 2011
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 Sonix Ultrasound Scanner, as described in your premarket notification:
Transducer Model Number
SA4-2/24 Phased Array SA3-1/24 Phased Array PA4-2/20 Phased Array PA7-4 Phased Arrav C5-2/60 and C5-2/60 GPS Convex C5-2/40 Convex
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Image /page/6/Figure/1 description: The image shows a list of different types of ultrasound transducers. The list includes C7-3/50 Convex, MC9-4/12 Microconvex, EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity, L9-4/38 Linear, L14-5/38 and L14-5/38 GPS Linear, L14-5W/60 Wide Linear, L15-8/26 Linear, BPL9-5/55 Linear Endocavity Biplane, BPC8-4/10 Microconvex Endocavity Biplane, HST15-8/20 Linear, 4DC7-3/40 Motorized Convex, 4d114-5/38 Motorized Linear, 4DEC9/5 Motorized Microconvex Endocavity, T7-4 Transesophageal Phased Array, TEM7-3/9 Transesophageal, mTEE8-3/5 Transesophageal, TEEIMA Transesophageal, IOT9-5/40 Convex Intraoperational, M4DC7-3/40 Motorized Convex, and L40-8/12 Linear.
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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
{7}------------------------------------------------
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely Yours,
Mary S. Redill
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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# Indications for Use Form
510(k) Number (if known): K | 12726
Device Name: Sonix Ultrasound Scanner
Indications for Use:
The Sonix Ultrasound Scanner is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access, Transcranial.
The system also provides the ability to measure anatomical structures {fetal,abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical dataobtained by a physician for clinical diagnosis purposes.
X Prescription Use Over-The-Counter Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patil
Division Sign off
Division Sign-C Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112726
। Page 1 of
-"
1
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## Sonix Ultrasound Scanner - Diagnostic Ultrasound Indications for Use Form
#### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] |
| Ophthalmic | P | P | P | P | P | P | P | P[3-6,8] |
| Fetal | P | P | P | P | P | P | P | P[3-8,11] |
| Abdominal | P | P | P | P | P | P | P | P[3-8,11] |
| Intraoperative1 | P | P | P | P | P | P | P | P[3-8] |
| Intraoperative Neurological | P | P | P | P | P | P | P | P[3-8] |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8,11] |
| Small Organ2 | P | P | P | P | P | P | P | P[3-8,11] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P[3-6,8,11] |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8,11] |
| Cardiac | P | P | P | P | P | P | P | P[3-6,8] |
| Transesophageal | P | P | P | P | P | P | P | P[3-6,8] |
| Transrectal | P | P | P | P | P | P | P | P[3-8,11] |
| Transvaginal | P | P | P | P | P | P | P | P[3-8,11] |
| Transurethral | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P[3-6,8] |
| Peripheral Vascular | P | P | P | P | P | P | P | P[3-8,11] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | P | P | P | P | P[3-8,11] |
| MSK Superficial | P | P | P | P | P | P | P | P[3-8,11] |
| Vascular Access | P | P | P | P | P | P | P | P[3-8,10,11] |
| Nerve Block | P | P | P | P | P | P | P | P[3-9,11] |
| Other | | | | | | | | |
#### N = New indication; P = Previously cleared under K093462
#### Notes :
- Abdominal organs and vascular 1
- Breast, Thyroid, Testicle 2
- Elastography 3
- Panoramic Imaging র্ব
- 5 Compound Imaging
- Freehand 3D Imaging 6
- Live 3D/4D Imaging 7
- 8 Imaging for guidance of biopsy
- g Imaging for guidance of nerve block injections
- Imaging for guidance of central or peripheral lines 10
- Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 11
- 12 B/PW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
1
Prescription Use Only
Mary S. Postel
---
(Division Sign-Off)
510K
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{10}------------------------------------------------
## SA4-2/24 Phased Array Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] |
| Intraoperative¹ | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] |
| Small Organ² | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P[3-6,8] |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Cardiac | P | P | P | P | P | P | P | P[3-6,8] |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P[3-6,8] |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
## N = New indication; P = Previously cleared under K093462
#### Notes:
- 1 Abdominal organs and vascular
- Breast, Thyroid, Testicle 2
- Elastography ઉ
- য Panoramic Imaging
- 5 Compound Imaging
- Freehand 3D Imaging 6
- 7 Live 3D/4D Imaging
- 8 Imaging for guidance of biopsy
- റ്റ Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Doppler (Triplex CW), B/Power Doppier/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
Appendix C: Transdcuer Specifications
Prescription Use Only
2
Mary Pastel
(Division Sign-Off)
SONIX User Manual
Division of Badiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112726
{11}------------------------------------------------
## SA3-1/24 Phased Array Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | Other<br>[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|----------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] | |
| Intraoperative1 | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] | |
| Small Organ2 | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P[3-6,8] | |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] | |
| Cardiac | P | P | P | P | P | P | P | P[3-6,8] | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P[3-6,8] | |
| Peripheral Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| MSK Conventional | | | | | | | | | |
| MSK Superficial | | | | | | | | | |
| Vascular Access | | | | | | | | | |
| Nerve Block | | | | | | | | | |
| Other | | | | | | | | | |
#### N = New indication; P = Previously cleared under K093462
#### Notes:
- Abdominal organs and vascular 1
- Breast, Thyroid, Testicle 2
- Elastography 3
- ব Panoramic Imaging
- 5 Compound Imaging
- ଚ Freehand 3D Imaging
- 7 Live 3D/4D Imaging
- 8 Imaging for guidance of biopsy
- റ്റ Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), BiPower Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
SONIX User Manual
3
Appendix C: Transdcuer Specifications
**Prescription Use Only**
Mary S. Patel
---
(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112706
{12}------------------------------------------------
## PA4-2/20 Phased Array Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] |
| Intraoperative¹ | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] |
| Small Organ² | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Cardiac | P | P | P | P | P | P | P | P[3-6,8] |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P[3-6,8] |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
## N = New indication; P = Previously cleared under K093462
#### Notes:
- 1 Abdominal organs and vascular
- Breast, Thyroid, Testicle 2
- Elastography 3
- 4 Panoramic Imaging
- 5 Compound Imaging
- Freehand 3D Imaging റ്റ്
- Live 3D/4D Imaging 7
- 8 Imaging for guidance of biopsy
- 9 Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 BIM, BIPW Dopler or CW Dopler (Triplex) or CW Doppler (Triplex CW), BIPower Doppler/PW Dopler or CW Doppler, Simultaneous Cotor Doppler or Power Doppler
す
Appendix C: Transdcuer Specifications
Prescription Use Only
(Division Sign-Off)
Division of Radiological Devices Office of In itro Diagnostic Device Evaluation and Safety
510K KILAUAC
SONIX User Manual
{13}------------------------------------------------
## PA7-4 Phased Array Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Other<br>[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] |
| Small Organ2 | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P[3-6,8] |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Cardiac | P | P | P | P | P | P | P | P[3-6,8] |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P[3-6,8] |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
## N = New indication; P = Previously cleared under K093462
#### Notes:
- 1 Abdominal organs and vascular
- Breast, Thyroid, Testicle 2
- Elastography ਤੇ
- 4 Panoramic Imaging
- 5 Compound Imaging
- 6 Freehand 3D Imaging
- 7 Live 3D/4D Imaging
- 8 lmaging for guidance of biopsy
- Imaging for guidance of nerve block injections റ്റ
- Imaging for guidance of central or peripheral lines 10
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), BIPower Doppler/PW Doppler/PW Dopper or CW Doppler, Simultaneous Color Doppler or Power Doppler
SONIX User Manual
5
Appendix C: Transdcuer Specifications
Mary Pastel
(Division Sign On)
sion Sign-Of Division of Radiological Devices Office of In Juation and Safety
510K K112726
{14}------------------------------------------------
## C5-2/60 and C5-2/60 GPS Convex Transducers
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Other<br>[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P[3-6,8,11] |
| Abdominal | P | P | P | | P | P | P | P[3-6,8,11] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[3-6,8,11] |
| Small Organ2 | P | P | P | | P | P | P | P[3-6,8,11] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[3-6,8,11] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[3-6,8,11] |
| MSK Superficial | P | P | P | | P | P | P | P[3-6,8,11] |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
## N = New indication; P = Previously cleared under K093462
#### Notes:
- Abdominal organs and vascular 1
- Breast, Thyroid, Testicle 2
- Elastography 3
- Panoramic Imaging 4
- ട Compound Imaging
- Freehand 3D Imaging 6
- Live 3D/4D Imaging 7
- 8 Imaging for guidance of biopsy
- മ Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Dopler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
Appendix C: Transdcuer Specifications
Prescription Use Only
Mary S. Patil
(Div sion Sign-Division of Radiologic Office of In raluation and Safety
510K Kบลาวช
SONIX User Manual
6
{15}------------------------------------------------
## C5-2/40 Convex Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] |
|-----------------------------|---|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P[3-6,8] |
| Abdominal | P | P | P | | P | P | P | P[3-6,8] |
| Intraoperative¹ | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[3-6,8] |
| Small Organ² | P | P | P | | P | P | P | P[3-6,8] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[3-6,8] |
| MSK Superficial | P | P | P | | P | P | P | P[3-6,8] |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
## N = New indication; P = Previously cleared under K093462
#### Notes :
- 1 Abdominal organs and vascular
- Breast, Thyroid, Testicle 2
- Elastography 3
- র্ব Panoramic Imaging
- ર Compound Imaging
- Freehand 3D Imaging 6
- 7 Live 3D/4D Imaging
- Imaging for guidance of biopsy 8
- ക Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
SONIX User Manual
7
Appendix C: Transdcuer Specifications
Man S. Patel
(Division Sign-Off)
Division of Radiological Devices Office of In
510K KULAC
{16}------------------------------------------------
#### C7-3/50 Convex Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P[3-6,8] |
| Abdominal | P | P | P | | P | P | P | P[3-6,8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[3-6,8] |
| Small Organ2 | P | P | P | | P | P | P | P[3-6,8] |
| Neonatal Cephalic | P | P | P | | P | P | P | P[3-6,8] |
| Adult Cephalic | P | P | P | | P | P | P | P[3-6,8] |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[3-6,8] |
| MSK Superficial | P | P | P | | P | P | P | P[3-6,8] |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
## N = New indication; P = Previously cleared under K093462
#### Notes:
- Abdominal organs and vascular 1
- 2 Breast, Thyroid, Testicle
- Elastography 3
- এ Panoramic Imaging
- 5 Compound Imaging
- 6 Freehand 3D Imaging
- 7 Live 3D/4D Imaging
- Imaging for guidance of biopsy છ
- 9 Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopter (Triplex CW), B/Power Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
8
Appendix C: Transdcuer Specifications
Mary S. Roth
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112726
SONIX User Manual
{17}------------------------------------------------
#### MC9-4/12 Microconvex Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P[3-6,8] |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] |
| Small Organ2 | P | P | P | P | P | P | P | P[3-6,8] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P[3-6,8] |
| Peripheral Vascular | P | P | P | P | P | P | P | P[3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | P | P | P | P | P[3-6,8] |
| MSK Superficial | P | P | P | P | P | P | P | P[3-6,8] |
| Vascular Access | P | P | P | P | P | P | P | P[3-6,8,10] |
| Nerve Block | P | P | P | P | P | P | P | P[3-6,8,9] |
| Other | | | | | | | | |
## N = New indication; P = Previously cleared under K093462
#### Notes:
- Abdominal organs and vascular 1
- Breast, Thyroid, Testicle 2
- Elastography 3
- র্ব Panoramic Imaging
- 5 Compound Imaging
- Freehand 3D Imaging 6
- 7 Live 3D/4D Imaging
- 8 Imaging for guidance of biopsy
- Imaging for guidance of nerve block injections 9
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 BIM, BIPW Doppler or CW Dopler (Triplex) or CW Dopter (Triplex CW), BPOwer Doppler/PW Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
9
SONIX User Manual
Appendix C: Transdcuer Specifications
Mary S. Pastl
(Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K KII2A26
{18}------------------------------------------------
## EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity Transducers
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | Other [Notes] |
|-----------------------------|-------------------|---|------------|------------|---------------|---------------|------------------|-------------|---------------|
| | B | M | PW Doppler | CW Doppler | Color Doppler | Power Doppler | Combined Modes12 | | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intraoperative1 | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ2 | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P[3-6,8,11] | |
| Transvaginal | P | P | P | | P | P | P | P[3-6,8,11] | |
| Transurethral | | | | | | | | | |
| Transcranial | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| MSK Conventional | | | | | | | | | |
| MSK Superficial | | | | | | | | | |
| Vascular Access | | | | | | | | | |
| Nerve Block | | | | | | | | | |
| Other | | | | | | | | | |
#### N = New indication; P = Previously cleared under K093462
#### Notes:
- 1 Abdominal organs and vascular
- Breast, Thyroid, Testicle 2
- Elastography ਤੇ
- ধ Panoramic Imaging
- 5 Compound Imaging
- Freehand 3D Imaging ଚ
- Live 3D/4D Imaging 7
- 8 Imaging for guidance of biopsy
- 9 Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 B/M, B/PW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CV), B/Power Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
10
Appendix C: Transdcuer Specifications
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. Kilana
SONIX User Manual
SONIX User Manual
{19}------------------------------------------------
## L9-4/38 Linear Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P[3-6,8] |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] |
| Small Organ2 | P | P | P | P | P | P | P | P[3-6,8] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Adult Cephalic | P | P | P | P | P | P | P | P[3-6,8] |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P[3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | P | P | P | P | P[3-6,8] |
| MSK Superficial | P | P | P | P | P | P | P | P[3-6,8] |
| Vascular Access | P | P | P | P | P | P | P | P[3-6,8,10] |
| Nerve Block | P | P | P | P | P | P | P | P[3-6,8,9] |
| Other | | | | | | | | |
#### N = New indication; P = Previously cleared under K093462
#### Notes:
- Abdominal organs and vascular 1
- Breast, Thyroid, Testicle 2
- Elastography 3
- র্ণ Panoramic Imaging
- ર Compound Imaging
- Freehand 3D Imaging ଚି
- Live 3D/4D Imaging 7
- 8 Imaging for guidance of blopsy
- g Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 B/M, B/PW Doppler or CW Dopler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
SONIX User Manual
Prescription Use Only
11
Appendix C: Transdcuer Specifications
Mary S. Pastel
ivision Sian-Off Division of Radiological Devices Office of In Vitro Diagnostic D nd Safety
510K K11272C
{20}------------------------------------------------
## L14-5/38 and L14-5/38 GPS Linear Transducers
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>(Notes) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P[3-6,8,11] |
| Abdominal | P | P | P | | P | P | P | P[3-6,8,11] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P[3-6,8,11] |
| Small Organ2 | P | P | P | | P | P | P | P[3-6,8,11] |
| Neonatal Cephalic | P | P | P | | P | P | P | P[3-6,8,11] |
| Adult Cephalic | P | P | P | | P | P | P | P[3-6,8,11] |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P[3-6,8,11] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P[3-6,8,11] |
| MSK Superficial | P | P | P | | P | P | P | P[3-6,8,11] |
| Vascular Access | P | P | P | | P | P | P | P[3-6,8,10,11] |
| Nerve Block | P | P | P | | P | P | P | P[3-6,8,9,11] |
| Other | | | | | | | | |
N = New indication; P = Previously cleared under K093462
Notes:
- 1 Abdominal organs and vascular
- Breast, Thyroid, Testicle 2
- Elastography ന
- प Panoramic Imaging
- 5 Compound Imaging
- Freehand 3D Imaging 6
- 7 Live 3D/4D Imaging
- 8 Imaging for guidance of biopsy
- 9 Imaging for guidance of nerve block injections
- 10 Imaging for guidance of central or peripheral lines
- 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer).
- 12 BIM, BIPW Doppler or CW Doppler (Triplex) or CW Dopter (Triplex CW), BPPower Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler
12
Appendix C: Transdcuer Specifications
Prescription Use Only
Mary S. Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic De Evaluation and Safety
510K. Kucnac
SONIX User Manual
{21}------------------------------------------------
## L14-5W/60 Wide Linear Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Other<br>[Notes] |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P[3-6,8] |
| Abdominal | P | P | P | P | P | P | P | P[3-6,8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P[3-6,8] |
| Small Organ2 | P…
