SONIXTABLET ULTRASOUND SCANNER
Device Facts
| Record ID | K113663 |
|---|---|
| Device Name | SONIXTABLET ULTRASOUND SCANNER |
| Applicant | Ultrasonix Medical Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Jan 25, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, 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 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
SonixTABLET is a mobile, software-controlled diagnostic ultrasound system. It acquires primary/secondary harmonic ultrasound echo data via various transducers (linear, convex, phased array, microconvex, TEE). The system transforms these inputs into B-Mode, M-Mode, Pulsed/Continuous Wave Doppler, Color Doppler, and Amplitude Doppler images displayed on a flat panel. Operated by clinicians in clinical settings, it includes an optional ECG display, measurement/calculation packages for fetal biometry and anatomical structures, and DICOM storage. The device uses a programmable digital beamformer and backend processing to generate real-time images. Output assists clinicians in diagnosis and procedural guidance (biopsy, nerve block, vascular access). Benefits include portable, real-time diagnostic imaging and fluid flow analysis.
Clinical Evidence
Bench testing only. The device complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Acoustic output limits (ISPTA, TIS/TIB/TIC, MI, ISPPA) are within the guidelines for Track 3 ultrasound devices and are identical to the predicate device.
Technological Characteristics
Mobile ultrasound system with programmable digital beamformer. Transducers use piezoelectric material for ultrasound transmission/reception. Supports linear, convex, microconvex, and phased array probes. Connectivity includes DICOM. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AIUM AOL, and NEMA UD-3 standards. Biocompatible patient-contact materials.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body in clinical applications including 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. Used by clinicians for anatomical measurements and diagnostic support.
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
- SonixTABLET Ultrasound Scanner (K102997)
Related Devices
- K102997 — SONIXTABLET ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Dec 21, 2010
- K112726 — SONIX ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Sep 27, 2011
- K093462 — SONIX ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Nov 20, 2009
- K193510 — Terason uSmart3200T Ultrasound System · Teratech Corporation · Jan 28, 2020
- K201633 — Terason uSmart 3200T Plus Ultrasound System · Teratech Corporation · Jul 2, 2020
Submission Summary (Full Text)
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## 510 (k) Summary for the SonixTABLET Ultrasound Scanner
JAN 2 5 2012
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 2009 revision 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
SonixTABLET 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:
SonixTABLET Ultrasound Scanner (K102997) Predicate transducer for m4DC7-3/40: 4DC7-3/40 cleared under K102997 Predicate transducer for L40-8/12: L14-5/38 and HST15-8/20, both are cleared under K102997
## 2.6 Reason for submission:
## Clearance request for:
Addition of the following two transducers to SonixTABLET Ultrasound Scanner which was previously cleared under K102997.
- . m4DC7-3/40
- L40-8/12 .
Note:
Indications for use and modes of operation of the SonixTABLET Ultrasound Scanner previously cleared under K102997 are unchanged.
## Name change request
N/A
## New product clearance for:
N/A
## 2.7 Device description
The SonixTABLET 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.
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The system has an optional electrocardiography (ECG) display feature and support for a 3lead 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 SonixTABLET 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.
| Frequency Range | 2-40MHz |
|------------------|-------------------|
| Transducer types | Linear array |
| | Curved array |
| | TEE array |
| | Intracavity array |
| | Phased array |
The SonixTABLET Ultrasound Scanner is designed to comply with the following standards and the system follows Track 3.
| Reference<br>Number | Title | FDA Recognition<br>Number |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| IEC 60601-1 | IEC 60601-1, Medical Electrical Equipment - Part 1: General<br>Requirements for Safety, 1988: Amendment 1, 1991-11.<br>Amendment 2, 1995. | 5-4 |
| IEC 60601-1-2 | IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General<br>Requirements for Safety - Collateral standard: Electromagnetic<br>Compatibility - Requirements and Tests (Edition 2:2001 with<br>Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated<br>with Amendment 1:2004)). | 5-34 |
| IEC 60601-2-37 | IEC 60601-2-37 (2004) (2005) Amendment 2, Medical electrical<br>equipment - Part 2-37: Particular requirements for the basic<br>safety and essential performance of ultrasonic medical<br>diagnostic and monitoring equipment. | 12-198 |
| AIUM AOL | Acoustic Output Labeling Standard for Diagnostic Ultrasound<br>Equipment Revision 1 - A standard for How Manufacturers<br>Should Specify Acoustic Output Data | 12-193 |
| AIUM RTD1-<br>2004 | Standard for Real - Time Display of Thermal and Mechanical<br>Acoustic Output Indices on Diagnostic Ultrasound Equipment<br>Revision 1 | 12-140 |
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## 3.0 Summary of Intended Uses
The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, 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 SonixTABLET 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 SonixTABLET 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.
SonixTABLET Ultrasound Scanner (K102997) Predicate transducer for m4DC7-3/40: 4DC7-3/40 cleared under K102997 Predicate transducer for L40-8/12: L14-5/38 and HST15-8/20, both are cleared under K102997
## 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.
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## 6.0 Safety considerations
As track 3 ultrasound device, the SonixTABLET 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 SonixTABLET Ultrasound Scanner complies with the guideline limits set in the September 9, 2008 revision of 510(k) Diagnostic Ultrasound Guidance.
With regard to general safety, the SonixTABLET Ultrasound Scanner is designed to comply with IEC 60601-1 (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 & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three overlapping profiles suggesting movement or layers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ultrasonix Medical Corporation % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW Buffalo MN 55313
JAN 2 5 2012
Re: K113663
Trade/Device Name: SonixTABLET Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: January 9, 2012 Received: January 10, 2012
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 DUS 6000 Digital Ultrasonic Imaging System, as described in your premarket notification:
### Transducer Model Number
4DC7-3/40 Motorized Convex Radius 4DEC9-5/10 Motorized Microconvex Endocavity Radius 4DL14-5/38 Motorized Linear BPL9-5/55 Linear Endocavity Biplane BPC8-4/10 Microconvex Endocavity Biplane C5-2/60 and C5-2/60 GPS Convex C7-3/50 Convex MC9-4/12 Microconvex EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity Radius HST15-8/20 Linear L9-4/38 Linear
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### L14-5/38 and L14-5/38 GPS Linear L14-5W/60 Wide Linear PA7-4/12 Phased Array SA4-2/24 Phased Array mTEE8-3/5 Transesophageal Phased Array Radius m4DC7-3/40otorized Micro Convex Radius 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/ucm115809.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 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 Jeffrey Ballyns, Ph.D. at (301) 796-6105.
Sincerely Yours,
Mary S Pastel
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): K113663
Device Name: SonixTABLET Ultrasound Scanner
Indications for Use:
The SonixTABLET Ultrasound Scanner is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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. Pastel
510K. K113663
Page 1 of _1
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## diagnostic ultrasound indications for use form
### SONIXTABLET ULTRASOUND SCANNER
| 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 [3-8,11] |
| Abdominal | P | P | P | P | P | P | P | P [3-8,11] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | P- | P. | P. | | P | P- | P | P [3-6,8] |
| Pediatric | P | P | P | P | P | P | P | P [3-8,11] |
| Small Organ2 | P | P | P | | P | P | P | P [3-8,11] |
| Neonatal Cephalic | 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 [3-8,8,11] |
| Transesophageal | P | P | P | P | P | P | P | |
| Transrectal | P | P | P | P | P | P | P | P [3-8,11] |
| Transvaginal | 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 [3-6,8,10,11] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P [3-8,11] |
| MSK Superficial | P | P | P | | P | P | P | P [3-8,11] |
| Vascular Access | P | P | P | | P | P | P | P [3-8,10,11] |
| Nerve Block | P | P | P | | P | P | P | P [3-8,8-9,11] |
| Other | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
#### Notes:
- 1. Abdominal organs and vascular
- Breast, Thyroid, Testicle 2.
- Elastography రా
- 4. Panoramic Imaging
- Compound Imaging ട.
- Freehand 3D Imaging e.
- Live 3D/4D Imaging 7.
- Imaging for guidance of biopsy 8.
- Imaging for guidance of nerve block injections ക്
- 10. Imaging for guidance of central or peripheral lines
-
- 10. Imaging to goldarce or chiralines
11. Volume Navigation/SontsGots'SorisCles (avaiable only with the GPS transluces)
12. BM, BPW Dopler or CW Dopler (Triplex) or Simultaneous Color Doppler or Power Dopplar.
Mary Pastel
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113663
Prescription Use Only
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### 4DC7-3/40 Motorized Convex Radius Transducer
| | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|----------------------|------------------|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes 12 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P [3-8] |
| Abdominal | P | P | P | | P | P | P | P [3-8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P [3-8] |
| Small Organ2 | P | P | P | | P | P | P | P [3-8] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P [3-8] |
| MSK Superficial | P | P | P | | P | P | P | P [3-8] |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
#### Notes:
1. Abdominal organs and vascular
- Breast, Thyroid, Testicle 2.
- 3. Elastography
- Panoramic Imaging ব :
- ട. Compound Imaging
- 6. Freehand 3D Imaging
- 7. Live 3D/4D Imaging
- Imaging for guidance of biopsy 8.
- റ്റ. Imaging for guidance of nerve block injections
10. Imaging for guidance of central or peripheral lines
-
- 11. Mulune Navigation/image Fusions/sers/ (available only with the GPS transluces)
12. BM, BJPW Oopler or CV Dopler (Triplex) or CW Dopler (Triplex CW), BPower Simultaneous Color Doppler or Power Doppler.
Mary Postel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety 510k
{10}------------------------------------------------
### 4DEC9-5/10 Motorized Microconvex Endocavity Radius Transducer
| 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 | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ2 | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P [3-8] |
| Transvaginal | P | P | P | | P | P | P | P [3-8] |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
#### Notes:
- 1. Abdominal organs and vascular
- Breast, Thyroid, Testicle 2.
- Elastography റ്റ്
- 4. Panoramic Imaging
- 5. Compound Imaging
- Freehand 3D Imaging 6.
- Live 3D/4D Imaging 7.
- Imaging for guidance of biopsy 8.
- 9. Imaging for guidance of nerve block injections
- 10. Imaging for guidance of central or peripheral lines
-
- 11 Meangler of Januarian (Teles) (available only with the GPS transducer)
11. Volume Navigationimage Fusion(Sonix(Triplex) or CW Dopler (Triplex CW), BPower Doppler or C Simultaneous Color Doppler or Power Doppler.
510
Mary S Padelf
(Division Sign-Off)
Office of In Vitro Diagnostic Device Evaluation and Safety
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### 4DL14-5/38 Motorized Linear Transducer
| Clinical Application | Mode of Operation | | | | | | | Other [Notes] |
|-----------------------------|-------------------|---|------------|------------|---------------|---------------|------------------|---------------|
| | B | M | PW Doppler | CW Doppler | Color Doppler | Power Doppler | Combined Modes12 | |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | P [3-8] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P [3-8] |
| Small Organ2 | P | P | P | | P | P | P | P [3-8] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P [3-8] |
| MSK Superficial | P | P | P | | P | P | P | P [3-8] |
| Vascular Access | P | P | P | | P | P | P | P [3-8,10] |
| Nerve Block | P | P | P | | P | P | P | P [3-9] |
| Other | | | | | | | | |
## Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
#### Notes:
- Abdominal organs and vascular 1.
- Breast, Thyroid, Testicle 2.
- Elastography છં.
- Panoramic Imaging ধ .
- ട. Compound Imaging
- 6. Freehand 3D Imaging
- Live 3D/4D Imaging 7.
- Imaging for guidance of biopsy 8.
- Imaging for guidance of nerve block injections 9.
- 10. Imaging for guidance of central or peripheral lines
-
- 10. Inflaging in Linka of Leineral Mos
11. Volume Navigation/SonxGPS" (available only with the GPS transduce)
12. BM, BPW Oopler, BC/PW Dopler (Triplex) or CW Dopler Simultaneous Color Doppler or Power Doppler.
4
Mary S. Patel
(Division Sign Off)
(Division Sign-Off Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety
510K K113663
{12}------------------------------------------------
### BPL9-5/55 Linear Endocavity Biplane Transducer
| 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 | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ2 | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | P [3-6,8] |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
## Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
- Abdominal organs and vascular 1.
- Breast, Thyroid, Testicle ip
- 3. Elastography
- 4. Panoramic Imaging
- Compound Imaging ક.
- Freehand 3D Imaging റ്.
- 7. Live 3D/4D Imaging
- Imaging for guidance of biopsy 8.
- Imaging for guidance of nerve block injections g.
- 10. Imaging for guidance of central or peripheral lines
-
- 11. Inading the drition deliver in least in east in and the GPS transducer)
11. BM. Blevigation on CW Dopler (Triplex) or CW Dopler (Triplex CW), BPower Dopler or CW Do Simultaneous Color Doppler or Power Doppler.
Mary S Patel
(Division Sign-Off)
Office of In nd Safety
510K K113663
{13}------------------------------------------------
### BPC8-4/10 Microconvex Endocavity Biplane Transducer
| 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 | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ2 | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | P [3-6,8] |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
- Abdominal organs and vascular 1.
- Breast, Thyroid, Testicle 2.
- 3. Elastography
- 4. Panoramic Imaging
- Compound Imaging 5.
- Freehand 3D Imaging હં.
- 7. Live 3D/4D Imaging
- Imaging for guidance of biopsy 8.
- lmaging for guidance of nerve block injections റ്റ്.
- 10. Imaging for guidance of central or peripheral lines
-
- 10. Imaging to central or Dentral inis
11. Volune Variation (Sentral or Dellera) " (avalable only with the GPS transducer)
12. Blan, Blev Oopler, or CV Simultaneous Color Doppier or Power Doppler.
Mary S. Pastel
(Division Sign-Off)
Division of Radiol itro D agnostic Device Evaluation and Safety
**Prescription Use Only**
{14}------------------------------------------------
### C5-2/60 and C5-2/60 GPS Convex Transducers
| | 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 [3-6,8,11] |
| Abdominal | P | 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 | P [3-6,8,11] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | P [3-6,8,11] |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | 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 | | | | | | | | |
### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
- t. Abdominal organs and vascular
- Breast, Thyroid, Testicle 2.
- Elastography 3.
- Panoramic Imaging ব :
- 5. Compound Imaging
- Freehand 3D Imaging 6.
- Live 3D/4D Imaging 7.
- Imaging for guidance of biopsy 8.
- 9. Imaging for guidance of nerve block injections
- 10. Imaging for guidance of central or peripheral lines
- 11. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transducer)
- 12. B/M, B/PW Dopler or CW Dopler (Triplex) or CW Dopber (Triplex CW), B/Power Doppler/W Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler.
Bivision Sig
Division of Radiological Devices Office of In Vitro Diagric Evaluation and Safety
f In Vitro Diagnostic Device Evaluation and Sa
510K K113663
{15}------------------------------------------------
### C7-3/50 Convex Transducer
| 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 | P | P | P | | P | P | P | P [3-6,8] |
| 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 | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
- 1. Abdominal organs and vascular
- Breast, Thyroid, Testicle 2.
- Elastography 3.
- 4. Panoramic Imaging
- 5. Compound Imaging
- 6. Freehand 3D Imaging
- 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/SonixGPS™ (available only with the GPS transducer)
- 12. BMM, BPW Doptier, ar CV Doppler (Triplex) or CW Dopler (Triplex CW), BPower Doppler/W Doppler or CW Dopler or CW Dopler, Simultaneous Color Doppler or Power Doppler.
Mary Patel
(Division Sign-Off)
Division of Radiclogical Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K
{16}------------------------------------------------
### MC9-4/12 Microconvex Transducer
| 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 [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 | P | P | P | | P | P | P | P [3-6,8] | |
| Peripheral Vascular | P | P | P | | P | P | P | P [3-6,8,10] | |
| 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 | P | P | P | | P | P | P | P [3-6,8,10] | |
| Nerve Block | P | P | P | | P | P | P | P [3-6,8-9] | |
## Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
#### Notes:
- Abdominal organs and vascular 1.
- 2. Breast, Thyroid, Testicle
- Elastography 3.
- Panoramic Imaging 4.
- Compound Imaging ട്
- ട. Freehand 3D Imaging
- Live 3D/4D Imaging 7.
- Imaging for guidance of biopsy 8.
- Imaging for guidance of nerve block injections 9.
10. Imaging for guidance of central or peripheral lines
-
- 10. Imaging to guidanea manillea inies
11. Volune Navigation (Rentralianes) (Cityle Caralder)
12. BM, BPW Ogpler or CV Dopler (Triplex) or CW Dopler (Triplex CV), Simultaneous Color Doppler or Power Doppler.
510K
Mary Stastel
(Division Sign-Off)
Division of Rachological Devices Office of In Vitro Diagnostic Davica Evaluation and Safety
**Prescription Use Only**
.
{17}------------------------------------------------
### EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity Radius Transducer
| 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 | | | | | | | | |
| 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 | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
#### Notes:
- 1. Abdominal organs and vascular
- Breast, Thyroid, Testicle in
- 3. Elastography
- Panoramic Imaging 4.
- Compound Imaging 5.
- Freehand 3D Imaging ર.
- 7. Live 3D/4D Imaging
- 8. Imaging for guidance of biopsy
- Imaging for guidance of nerve block injections ക്
- 10. Imaging for guidance of central or peripheral lines
- 16. Imaging for galamos er contract portion SonixGPS™ (available only with the GPS transducer)
- 11. Volume Navgalonimage Frushionistic (avalable only will be Gr S ransadeer)
12. BM, BPW Dopler, BC/PW Dopler (Tiplex) or CW Dopler (Triplex CV), BPower Doppler/ BINI, Bir W Buppler or Power or Power Doppler.
રાજ્યન
---
Mary Patel
Office of In Evaluation and Sefety
{18}------------------------------------------------
### HST15-8/20 Linear Transducer
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] |
|-----------------------------|---|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | P | P | P | | P | P | P | P [3-6,8] |
| Pediatric | P | P | P | | P | P | P | P [3-6,8] |
| Small Organ2 | P | P | P | | P | P | P | P [3-6,6] |
| Neonatal Cephalic | P | P | P | | P | P | P | P [3-6,8] |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | P | P | P | | P | P | P | P [3-6,8] |
| 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 | P | P | P | | P | P | P | P [3-6,8,10] |
| Nerve Block | P | P | P | | P | P | P | P [3-6,8,9] |
| Other | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
#### Notes:
- 1. Abdominal organs and vascular
- Breast, Thyroid, Testicle 2.
- Elastography 3.
- 4. Panoramic Imaging
- ട. Compound Imaging
- Freehand 3D Imaging હ.
- 7. Live 3D/4D Imaging
- 8. Imaging for guidance of biopsy
- Imaging for guidance of nerve block injections න්
- 10. Imaging for guidance of central or peripheral lines
-
- 10. Intellig on gotter of cancerines inco
11. Volume Navigationinage Fusions (FS)" (avaiable only with the GPS transluce)
12. BM, BPW Dopler, or CW Dopler (Triplex) Simultaneous Color Doppler or Power Doppler.
**Prescription Use Only**
Mary S. Pastel
(Division Sign-Off)
Division of Reals logical Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K
{19}------------------------------------------------
## diagnostic ultrasound indications for use form
### L9-4/38 Linear Transducers
| 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 | 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 | P | P | P | | P | P | P | P [3-6,8,10] |
| Nerve Block | P | P | P | | P | P | P | P [3-6,8,9] |
| Other | | | | | | | | |
### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = New indication; P = Previously cleared under K102997
#### Notes:
- 1. Abdominal organs and vascular
- Breast, Thyroid, Testicle 2.
- Elastography 3.
- Panoramic Imaging ব :
- റ്. Compound Imaging
- 6. Freehand 3D Imaging
- Live 3D/4D Imaging 7.
- Imaging for guidance of biopsy 8.
- Imaging for guidance of nerve block injections g.
- 10. Imaging for guidance of central or peripheral lines
-
- 10. Inleging or enned of Enner F. Mos
11. Volume Navigation/SontsOns™ (available only with the GPS transbucer)
12. BM, BPW Dopler, or CV Dopler (Triplex) or CW Dopl Simultaneous Color Doppler or Power Doppler.
610K
Mary S Patel
division Sign-Off Division of Hactorological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{20}------------------------------------------------
### L14-5/38 and L14-5/38 GPS Linear Transducers
| | 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 [3-6,8,11] |
| Abdominal | P | P | P | P | P | P | P | P [3-6,8,11] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P…
