Who is the manufacturer of SONIXTOUCH ULTRASOUND SYSTEM?

Ultrasonix Medical Corporation filed the 510(k) submission for SONIXTOUCH ULTRASOUND SYSTEM (K083095).

What is the FDA product code for SONIXTOUCH ULTRASOUND SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SONIXTOUCH ULTRASOUND SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SONIXTOUCH ULTRASOUND SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SONIXTOUCH ULTRASOUND SYSTEM

Q: What are the predicate devices for SONIXTOUCH ULTRASOUND SYSTEM?

SONIX MDP Ultrasound Scanner (K080935); SONIX Ultrasound Scanner (K061827); SonoSite MicroMaxx High Resolution Ultrasound System (K053069); Philips HD 11 Diagnostic Ultrasound System (K062247); GE Logiq P5 and A5 (K060993); Imacor Zura TEE System (K080223); Siemens S2000 Diagnostic Ultrasound System (K072786); Volcano S5i Family of Ultrasound Systems (K061215).

K083095 · Ultrasonix Medical Corporation · IYN · Oct 31, 2008 · Radiology

Device Facts

Record ID	K083095
Device Name	SONIXTOUCH ULTRASOUND SYSTEM
Applicant	Ultrasonix Medical Corporation
Product Code	IYN · Radiology
Decision Date	Oct 31, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The SonixTouch 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, Intravascular, Laparoscopic. 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

SonixTouch is a mobile, software-controlled diagnostic ultrasound system; acquires harmonic ultrasound echo data; displays in B-Mode, M-Mode, Pulsed/Continuous Doppler, Color Doppler, Amplitude Doppler, and Elastography. Used in clinics/hospitals by physicians/technicians. Features include ECG display, measurement/calculation packages for fetal biometry and anatomical structures, cine review, image zoom, biopsy guidance, and DICOM storage. System uses piezoelectric transducers (linear, convex, phased, microconvex, TEE) to transmit/receive sound waves. Backend processing generates real-time images. Elastography mode extracts tissue mechanical properties by applying manual pressure; color-codes stiff vs. soft structures. Output displayed on flat panel; assists clinicians in diagnosis and interventional guidance (biopsy, nerve block, vascular access).

Clinical Evidence

Bench testing only. Verification protocol (00.046.088_Ultrasonix_OP-SP_2.7.0) confirmed the elasticity imaging algorithm can differentiate structures with different rigidity. Acoustic output limits and safety compliance verified against IEC 60601-1 and IEC 60601-2-37 standards.

Technological Characteristics

Mobile ultrasound system; piezoelectric transducers (linear, convex, phased, microconvex, TEE); 2-15 MHz frequency range. Programmable beamformer architecture. Modes: 2D, M-mode, PW/CW Doppler, Color Flow, Power Doppler, Elastography. Connectivity: DICOM. Safety: Track 3, IEC 60601-1, IEC 60601-2-37, AIUM standards. Biocompatible patient contact materials.

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, transcranial, intravascular, and laparoscopic applications.

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 MDP Ultrasound Scanner (K080935)
SONIX Ultrasound Scanner (K061827)
SonoSite MicroMaxx High Resolution Ultrasound System (K053069)
Philips HD 11 Diagnostic Ultrasound System (K062247)
GE Logiq P5 and A5 (K060993)
Imacor Zura TEE System (K080223)
Siemens S2000 Diagnostic Ultrasound System (K072786)
Volcano S5i Family of Ultrasound Systems (K061215)

Related Devices

K112726 — SONIX ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Sep 27, 2011
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
K112539 — CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE · Leiker Regulatory & Quality Consulting · Jan 30, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ K0r3095 ### 510 (k) Summary for the SonixTouch Ultrasound Scanner This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) summary. ### 1.0 Submitter Information ### 1.1 Submitter Ultrasonix Medical Corporation 130-4311 Viking Way Richmond, British Columbia Canada V6V 2K9 (t) 604-279-8550 (f) 604-279-8559 OCT 3 1 2008 ## 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 September 1, 2008 ### 2.0 Device Name ### 2.1 Common Name Ultrasound Imaging System ### 2.2 Proprietary Name SonixTouch 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 | {1}------------------------------------------------ ### 2.4 Classification Class II ### 2.5 Predicate Device: SONIX MDP Ultrasound Scanner (K080935) SONIX Ultrasound Scanner (K061827) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) Imacor Zura TEE System (K080223) Siemens S2000 Diagnostic Ultrasound System (K072786) Volcano S5i Family of Ultrasound Systems (K061215) ### 2.6 Reason for submission: ### Name change request N/A ### New product clearance for: SonixTouch Ultrasound Scanner and Transducers: L14-5/38 C5-2/60 C5-2/40 EC9-5/10 SA4-2/24 SA3-1/24 L14-5W/60 PA7-4 BPSL9-5/55 BPC8-4/10 C7-3/50 4DC7-3/40 4DL14-5/38 4DEC9-5/10 L9-4/38 MC9-4/12 HST15-8/20 L15-8/26 TEM7-3/9 TEM10-7/5 TEEIMA LAP {2}------------------------------------------------ ## 2.7 Device description The SonixTouch 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 SonixTouch 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 quides 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 | 2-15MHz | |------------------|-------------------| | Transducer types | Linear array | | | Curved array | | | TEE array | | | Intracavity array | | | Phased array | {3}------------------------------------------------ The SonixTouch 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 Electrical Equipment | | C22-2 No 601.1 | Canadian Standards Association, Medical Electrical Equipment | | EM 60601-1-2 | European Norm, Collateral Standard, Electromagnetic Compatibility | | IEC 60601-2-37 | Particular requirements for the safety of ultrasonic medical diagnostic equipment | | AIUM | Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment - Jan 1998 | | AIUM | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices | ### 3.0 Summary of Intended Uses The SonixTouch 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, Intravascular, Laparoscopic. 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 SonixTouch Ultrasound Scanner is substantially equivalent to the predicate devices with respect to intended use/indications for use, principles of operation and technological characteristics. The SONIX Touch 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. ### Elastography The Elastography imaging mode is similar to the Siemens S2000 Elasticity imaging mode implementation (also called eSie Touch Elasticity Imaging). {4}------------------------------------------------ The following slides explain the concept used for Elastography imaging: Elastography is a method to extract the mechanical properties of tissue # Comparison of Ultrasound Imaging Techniques Image /page/4/Picture/3 description: The image shows a medical ultrasound. The ultrasound displays a series of waveforms and grayscale images, likely representing blood flow or tissue density. The image also contains some text, but it is not legible. The ultrasound is likely being used for diagnostic purposes. B-mode Observe internal structure types and boundaries > Doppler modes Observe internal flow and tissue motion Elastography Observe mechanical properties of tissue The imaging method involves applying a mechanical pressure with the hand on the transducer. The actual imaging sequence is similar to the B-mode sequence except that the system will acquire the RF signal instead of acquiring B mode data. The acoustic output transmission is identical to B-mode. The algorithm extracts a strain value information for every point on the image. The Elastography image then color-codes the stiff versus softer structures. The clinical benefits of elastography imaging are still under evaluation and no clinical diagnosis claim can be made other than being able to tell whether or not a structure inside the patient is stiffer than another one. The submission includes a document "00.046.088_Ultrasonix_OP-SP_2.7.0_Release_Validation_Protocol_B_061308_ElastoValidation_Corina" included in the additional information dated October 14, 2008 which provides the verification protocol as well as expected results for elastography imaging. The report verifies the elasticity imaging algorithm (images actually in the validation protocol as well) can differentiate different structures with different rigidity {5}------------------------------------------------ # Elastography Imaging Technique Image /page/5/Picture/1 description: The image shows a dark screen with some text and graphical elements. The text "Soft" and "Hard" are visible on the left side of the screen, possibly indicating settings or options. There are some scattered bright spots and lines, which could be part of a user interface or some kind of data visualization. Due to the low resolution and contrast, it is difficult to discern the exact content or purpose of the screen. stiff structure displaced but RF data unchanged color coded in Blue softer structure displaced and RF data unchanged color coded in Red ## Elastography verification data The attached document "00.046.088_Ultrasonix_OP- SP 2.7.0 Release Validation Protocol B 061308_ElastoValidation_Corina" includes verification protocol as well as expected results for elastography imaging. The report verifies that our elasticity imaging algorithm (images actually in the validation protocol as well) passes and can differentiate different structures with different rigidity. ### 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 SonixTouch Ultrasound Scanner is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by the National Electrical Manufacturers Association as UD-3. {6}------------------------------------------------ With respect to limits on acoustic outputs, the SonixTouch Ultrasound Scanner complies with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance. With regard to general safety, the SonixTouch Ultrasound Scanner is designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601-2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment. The devices' acoustic output limits are: | ISPTA (d) | 720mW/cm² | |-----------------------|--------------------| | TIS/TIB/TIC | 0.1 - 4.0 (Range) | | Mechanical Index (MI) | 1.9 (Maximum) | | ISPPA (d) | 0-700W/cm² (Range) | The limits are the same as predicate Track 3 devices. {7}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is a symbol of strength and freedom, and the logo represents the department's mission to protect the health of all Americans and provide essential human services. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 5 - 2009 Ultrasonix Medical Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K083095 Trade/Device Name: SonixTouch Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 16, 2008 Received: October 17, 2008 Dear Mr. Job: This letter corrects our substantially equivalent letter of October 31, 2008. 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 SonixTouch Ultrasound System, as described in your premarket notification: #### Transducer Model Number SA4-2/24 Phased Array 2.8 MHz 24 mm SA3-1/24 Phased Array 2.0 MHz 24mm PA7-4 Phased Array 5.0 MHz C5-2/60 Convex 3.2 MHz 60mm Radius C5-2/40 Convex 3.2 MHz 40mm Radius C7-3/50 Convex 5.0 MHz 50mm Radius EC9-5/10 Microconvex Endocavity 6.6 MHz 10mm Radius L14-5/38 Linear 8 MHz 38mm L9-4/38 Linear 6.5 MHz 38mm L14-5W/60 Linear 8 MHz 38mm {8}------------------------------------------------ BPSL9-5/55/10L Linear ECBP 7.5 MHz BPSL9-5/55-10C Microconvex ECBP 6.5 MHz 4DC7-3/40mm 3D/4D Curved Transabdominal 3.5 MHz 4DEC9-5/10mm 3D/4D Endocavity 6.5 MHz MC9-4/12mm Mircoconvex 6.0 MHz 4DL14-5/38mm 3D/4D Linear 7.5 MHz HST15-8/20mm Hockey Stick Linear 10.0 MHz L15-8/26mm Linear 10.0 MHz TEM7-3/9mm Transesophageat 5.0 MHz TEM10-7/5mm Transesophageat 7.0 MHz TEEIMA Transesophageal 7.0 MHz LAP Laproscopic If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on vour responsibilities under the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html If you have any questions regarding the content of this letter, please contact Sunder Rajan at (240) 276-3666. Sincerely yours, Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {9}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: SonixTouch Ultrasound Scanner Indications For Use: The SonixTouch Ultrasound Scanner is intended for the following applications: Cardiac, Intraoperative (specific), Intraoperative Ophthalmic, Abdominal, Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Peripheral Vascular, Transvaginal, Transrectal, Transesophageal, 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 data obtained by a physician for clinical diagnosis purposes. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Helsleuen Page 1 of (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number K083095 {10}------------------------------------------------ ### ULTRASOUND INDICATIONS FOR USE TABLES ### SonixTouch 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 | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Fetal | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Abdominal | N | N | N | N | N | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Intraoperative Neurological | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Pediatric | N | N | N | N | N | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Neonatal Cephalic | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Adult Cephalic | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Cardiac | N | N | N | N | N | N | N | N | N (*1) | N (*2) | | Transesophageal | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Transrectal | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Transvaginal | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Transurethral | | | | | | | | | | | | Transcranial | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Peripheral Vascular | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Laparoscopic | N | N | N | N | | N | N | N | N (*1) | N (*2) | | MSK Conventional | N | N | N | N | | N | N | N | N (*1) | N (*2) | | MSK Superficial | N | N | N | N | | N | N | N | N (*1) | N (*2) | | Vascular Access | N | N | N | N | | N | N | N | N (*1) | N (*2, *4) | | Nerve Block | N | N | N | N | | N | N | N | N (*1) | N (*2, *3) | | Other (specify) | | | | | | | | | | | #### N = New indication; P = Previously cleared #### Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular - *1. BIM, BIPWD, BICWD, BICFMPWD, BIAD/PWD, BIOPD/PWD, BICFWCWD, B/AD/CWD, B/DPD/CWD - 1. DiM, Dr VVD, Drover Dopler (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, Live 3D/4D Imaging. - *3. Imaging for guldance of nerve block injections - Imaging for guidance of central or peripheral lines. *4. SONIX Touch User Manual _ ﻨﺴ 1 Appendix C: Transdcuer Specifications (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number {11}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form SA4-2/24 phased array 2.8 MHz 24mm transducer #### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|---------------------------|-----------------------|--------------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) | | Adult Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Transcranial | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | | | | | | | | | | | MSK Superficial | | | | | | | | | | | | Vascular Access | | | | | | | | | | | | Nerve Block | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular *1 B/M B/PWD. B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD eraries : 1000: Minister : 12:00:40 11. Bik, BPWD, B/CFM/PWD, B/DPWD, B/DPDP, Pancamic Imaging, Hamonic Imaging, Hamonic Imaging, Hamonic Imaging, Harmonic Imaging, Harmo Appendix C: Transdcuer Specifications 2 | (Division Sign-Off) | | |--------------------------------------------------------------|---------| | Division of Reproductive, Abdominal and Radiological Devices | | | 510(k) Number | K083095 | SONIX Touch User Manual {12}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form SA3-1/24 phased array 2.0 MHz 24mm transducer Intended use: ### Diagnostic ultrasound imaging or fluid flow anaiysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Adult Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Transcranial | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | | | | | | | | | | | MSK Superficial | | | | | | | | | | | | Vascular Access | | | | | | | | | | | | Nerve Block | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared #### Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular *1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/AD/CWD, B/DPD/CWD - *2. Elastography, Directional Power (DPD), Imaging for guidance of biopsy, Panoramle Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging. | SONIX Touch User Manual | Appendix C: Transdcuer Specifications | |--------------------------------------------------------------|---------------------------------------| | (Division Sign-Off) | | | Division of Reproductive, Abdominal and Radiological Devices | | 510(k) Number K023045 {13}------------------------------------------------ ### Diagnostic ULTRASOUND INDICATIONS FOR USE Form PA7-4 phased array 5.0 MHz transducer #### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Adult Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Transcranial | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | | | | | | | | | | | MSK Superficial | | | | | | | | | | | | Vascular Access | | | | | | | | | | | | Nerve Block | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared #### Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular *1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/OPD/CWD, B/OPD/CWD "1. BM, BPWU, BIGHWFWD, BIGHMFWD, DIAL/ WD, Drom You Crem Porter Corporation Imaging, Hamonic Imaging, Hamonic Imaging, Hamonic Imaging, Namonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging. Appendix C: Transdcuer Specifications 4 | (Division Sign-Off) | |-----------------------------------------| | Division of Reproductive, Abdominal and | Brasion of Roproduct 510/k) Number 083 510(k) Number SONIX Touch User Manual {14}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form C5-2/60 convex 3.2 MHz 60mm radius transducer Intended use: #### Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Trasncranial | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) | | MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) | | Vascular Access | | | | | | | | | | | | Nerve Block | | | | | | | | | | | | Other (specify) | | | | | | | | | | | #### N = New indication; P = Previously cleared #### Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular 1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD *1. BM, B/PWD, B/CWD, B/DPWVD, B/DPD/PWD, B/CFMCWD, B/AD/CWD, B/OPD/CWD *2. Elastography, Directional Power Dopels (DPD), Maging, Penoramic Imaging, Hamoric Imaging, Hamor | SONIX Touch User Manual | | Appendix C: Transdcuer Specifications | |-------------------------|--|---------------------------------------| |-------------------------|--|---------------------------------------| 5 | (Division Sign-Off) | | |-----------------------------------------|---------| | Division of Reproductive, Abdominal and | | | Radiological Devices, | | | 510(k) Number | K083095 | {15}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form C5-2/40 convex 3.2 MHz 40mm radius transducer #### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Trasncranial | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) | | MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) | | Vascular Access | | | | | | | | | | | | Nerve Block | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared #### Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular - *1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD 11. Elastography, Directional Power (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, | Appendix C: Transdcuer Specifications | | |---------------------------------------|-----------------------------------------| | | 6 | | | (Division Sign-Off) | | | Division of Reproductive, Abdominal and | | | SO | 4083095 Radiological Devices 510(k) Number SONIX Touch User Manual {16}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form Č7-3/50 convex 5.0 MHz 50mm radius transducer Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Trasncranial | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) | | MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) | | Vascular Access | | | | | | | | | | | | Nerve Block | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular *1. BIM, BIPWD, BICWD, BICFM/PWD, BIAD/PWD, BIDPD/PWD, BICFM/CWD, BI/DPD/CWD *2. Elastography, Directional Power Doppler (DPD), Imaging for guldance of biopsy, Panoramic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging. SONIX Touch User Manual Appendix C: Transdcuer Specifications 从 (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number {17}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form EC9-5/10 microconvex endocavity 6.6 MHz 10mm radius transducer Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Transvaginal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Transurethral | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | | | | | | | | | | | MSK Superficial | | | | | | | | | | | | Vascular Access | | | | | | | | | | | | Nerve Block | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular - *1. BM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/DPD/CWD - *2. Elastography, Directional Power (DPD), Imaging for guidance of biopsy, Panoramic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging. Appendix C: Transdcuer Specifications | (Division Sign-Off) | |---------------------| |---------------------| Division of Reproductive, Abdominal and Radiological Devices | 510(k) Number | 4083095 | |---------------|---------| |---------------|---------| SONIXIX Touch User Manual {18}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form L14-5/38 linear 8 MHz 38mm transducer Intended use: #### Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | | N | N | N (*1) | N (*2) | | Abdominal | | N | N | N | | | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | | | N | N | N (*1) | N (*2) | | Small Organ (specify) | | N | N | N | | | N | N | N (*1) | N (*2) | | Neonatal Cephalic | | N | N | N | | | N | N | N (*1) | N (*2) | | Adult Cephalic | | N | N | N | | | N | N | N (*1) | N (*2) | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | | N | N | N (*1) | N (*2) | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | N | N | N | | | N | N | N (*1) | N (*2) | | MSK Superficial | | N | N | N | | | N | N | N (*1) | N (*2) | | Vascular Access | | N | N | N | | | N | N | N (*1) | N (*2, *4) | | Nerve Block | | N | N | N | | | N | N | N (*1) | N (*2, *3) | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared #### Additional Comments: SONIX #### Small Organ: Breast, Thyroid, Testicle #### Intraoperative: Abdominal organs and vascular - - 11. BM, B/PWD, B/C/WD, B/O/PWD, B/DPPWD, B/DP/PWD, B/O/CWO, B/DPD/CWD *2. Elastography, Directional Power Dopels ( DPD), Maging for guitance of biopsy, Panoramic Imaging, - *3. Imaging for guidance of nerve block injections - *4. Imaging for guidance of central or peripheral lines. Touch User Manual Appendix C: Transdcuer Specifications | | 9 | |--|---------------------| | | (Division Sign-Off) | Division of Reproductive. Abdominal andDivision of Reproductive, Abdollian 510(k) Number ____________________________________________________________________________________________________________________________ {19}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form L9-4/38 linear 6.5 MHz 38mm transducer Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) | | Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) | | Adult Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) | | Laparoscopic | | | | | | | | | | | | MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) | | MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) | | Vascular Access | | N | N | N | | N | N | N | N (*1) | N (*2, *4) | | Nerve Block | | N | N | N | | N | N | N | N (*1) | N (*2, *3) | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared Additional Comments: Small Organ: Breast, Thyroid, Testicle Intraoperative: Abdominal organs and vascular - *1. BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD - 11. BM, BFWD, DVGYD, DVGT WT WO, Droin 105, Droi MSO, Dron Sor and Partic Partic Imaging, Harmonic Imaging, Harmonic Imaging, Tissue Doppler Imaging, Compound Imaging, Freehand 3D Imaging, - *3. Imaging for guidance of nerve block injections - *4. Imaging for guidance of central or peripheral lines. | Appendix C: Transdcuer Specifications | SONIX Touch User Manual | |--------------------------------------------------------------|-------------------------| | (Division Sign-Off) | | | Division of Reproductive, Abdominal and Radiological Devices | | | 510(k) Number | K083095 | {20}------------------------------------------------ #### Diagnostic ULTRASOUND INDICATIONS FOR USE Form L14-5W/60 linear 8 MHz 38mm transducer Intended use: #### Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Abdominal | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Small Organ (specify) | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Neonatal Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Adult Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | |…