SONIX ULTRASOUND SCANNER

K093462 · Ultrasonix Medical Corporation · ITX · Nov 20, 2009 · Radiology

Device Facts

Record IDK093462
Device NameSONIX ULTRASOUND SCANNER
ApplicantUltrasonix Medical Corporation
Product CodeITX · Radiology
Decision DateNov 20, 2009
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1570
Device ClassClass 2
AttributesPediatric, 3rd-Party Reviewed

Intended Use

The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral 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 diagnostic purposes.

Device Story

Sonix Ultrasound Scanner: mobile, software-controlled diagnostic ultrasound system. Inputs: harmonic ultrasound echo data from linear, convex, microconvex, and phased array transducers; 3-lead ECG cable assembly. Operation: digital beamformer transmits/receives signals; backend processing generates real-time 2D, M-mode, PW/CW Doppler, Color Doppler, Power Doppler, and harmonic images. Features: volume navigation, image fusion, GPS, panoramic imaging, compound imaging, elastography, cine review, image zoom, biopsy guidance, measurements, and calculations. Used in clinical settings by physicians/clinicians. Output: real-time images and measurements on flat panel display; DICOM storage. Benefits: provides anatomical/hemodynamic information for clinical diagnosis and procedural guidance (biopsy, nerve block, vascular access).

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-2-37, and NEMA UD-3 standards. Acoustic output limits (ISPTA 720mW/cm², MI 1.9) verified to be within Track 3 guidance limits. No clinical data presented.

Technological Characteristics

Mobile, software-controlled ultrasound system. Piezoelectric transducers (linear, convex, microconvex, phased array). Digital beamformer. Modes: 2D, M-mode, PW/CW Doppler, Color Flow, Power Doppler. Biocompatible patient contact materials. Complies with EN 60601-1, UL 2601-1, C22-2 No 601.1, EN 60601-1-2, IEC 60601-2-37, AIUM AOL, AIUM RTD. Track 3 acoustic output.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in Ophthalmic, Abdominal, Cardiac, Intraoperative, Neurological, Fetal, Pediatric, Small Parts, Neonatal/Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal, Pelvic, Nerve block, Vascular Access, and Transcranial applications. Used by clinicians for diagnostic purposes.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K093462 ### 510 (k) Summary for the Sonix Ultrasound Scanner · This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) summary. ## 1.0 Submitter Information ### 1.1 Submitter Ultrasonix Medical Corporation 130-4311 Viking Way Richmond, British Columbia Canada V6V 2K9 (t) 604-279-8550 (f) 604-279-8559 NOV 2 0 2009 # 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 October 10, 2008 ### 2.0 Device Name ## 2.1 Common Name Ultrasound Imaging System ## 2.2 Proprietary Name Sonix Ultrasound Scanner ### 2.3 Classification Name | | FR Number | Product Code | |------------------------------------------|-----------|--------------| | Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | {1}------------------------------------------------ ### 2.4 Classification Class II ### 2.5 Predicate Device: Sonix TOUCH Ultrasound Scanner (K083095) SONIX MDP Ultrasound Scanner (K080935) GE Logiq E9 (K082185) Ultraguide 1000 (K974432) Aegis (K070244) 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: ## Clearance request for: Sonix Ultrasound Scanner and the cleared transducers with additional/expanded indication for use: - Imaging of guidance of central or peripheral lines; . - Imaging for guidance of biopsy; ● - Imaging for guidance of nerve block injections; . - Volume Navigation/ Image Fusion/ GPS . - Panoramic imaging: . - Compound imaging; . - Elastography. . New Transducers: - SA4-2/24 . - SA3-1/24 . - 4DL14-5/38 - 4DEC9-5/10 - MC9-4/12 - HST15-8/20 - L15-8/26 - TEM7-3/9 - TEM10-7/5 - TEEIMA . ## Name change request N/A ## New product clearance for: N/A {2}------------------------------------------------ ## 2.7 Device description The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Morde, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording, capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle 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 | 2-15MHz | |------------------|-------------------| | Transducer types | Linear array | | | Curved array | | | TEE array | | | Intracavity array | | | Phased array | {3}------------------------------------------------ The Sonix Ultrasound Scanner is designed to comply with the following standards and the system follows Track 3. | EN 60601-1 | European Norm, Medical Electrical Equipment | |----------------|--------------------------------------------------------------------------------------| | UL 2601-1 | Underwriters Laboratories Standards, Medical<br>Electrical Equipment | | C22-2 No 601.1 | Canadian Standards Association, Medical<br>Electrical Equipment | | EN 60601-1-2 | European Norm, Collateral Standard,<br>Electromagnetic Compatibility | | IEC 60601-2-37 | Particular requirements for the safety of<br>ultrasonic medical diagnostic equipment | | AIUM AOL | Acoustic Output Labeling Standard for Diagnostic<br>Ultrasound Equipment | | AIUM RTD | Standard for Real-Time Display of Thermal and<br>Mechanical Acoustic Output Indices | ### 3.0 Summary of Intended Uses The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. ### 4.0 Comparison to Predicate Device The Sonix Ultrasound Scanner is substantially equivalent to the predicate devices listed below with respect to intended use/indications for use. principles of operation and technological characteristics. The Sonix Ultrasound Scanner includes a digital beamformer that is similar in function to the predicate devices beamformer. It allows transmitting and receiving signals through the ultrasound transducers. The ultrasound transducers are similar to the ones used on predicate devices. The backend processing is also similar to the predicate devices and yields an ultrasound image in realtime for diagnosis purposes. ### Sonix TOUCH Ultrasound Scanner (K083095) Sonix MDP Ultrasound Scanner (K080935) Ultraguide 1000 (K974432) GE Logia E9 (K082185) Aegis (K070244) Page 10 of 37 {4}------------------------------------------------ SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logig P5 and A5 (K060993) Imacor Zura TEE System (K080223) Siemens S2000 Diagnostic Ultrasound System (K072786) Volcano S5i Family of Ultrasound Systems (K061215) # 5.0 Technological characteristics The technological characteristics are substantially similar to that of the predicates. The device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D or M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler, Continuous Wave Doppler) are the same as the predicate devices identified in item 2.5. Transducer patient contact materials are biocompatible. The beam forming architecture is very similar to that of the predicate devices. The receiving and processing hardware is similar but innovative in that it is a programmable system made of 2 building blocks, which can be reconfigured to operate the system in any imaging mode. The parameters used to adjust image quality are the same as that seen in the predicates. This includes the use of TGC gain, depth control, base control and angling, among others. # 6.0 Safety considerations As track 3 ultrasound device, the Sonix Ultrasound Scanner is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by the National Electrical Manufacturers Association as UD-3. With respect to limits on acoustic outputs, the Sonix Ultrasound Scanner complies with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance. With regard to general safety, the Sonix Ultrasound Scanner is designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and EC 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) | {5}------------------------------------------------ The limits are the same as predicate Track 3 devices. . . and the comments of the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contrib . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : : : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . :: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : 1. September 2017 11:40 PM IST 10: Page 12 of 37 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a logo for the Department of Health & Human Services - CSA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - CSA" arranged around the circumference. Inside the circle is a stylized graphic of a bird or abstract human figure with outstretched arms, possibly representing care or support. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 Ultrasonix Medical Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street N.W. BUFFALO MN 55313 NOV 2 0 2009 Re: K093462 Trade/Device Name: Sonix 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: November 5, 2009 Received: November 6, 2009 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. This determination of substantial equivalence applies to the following transducers intended for use with the Sonix Ultrasound Scanner Diagnostic Ultrasound System, as described in your premarket notification: Transducer Model Number SA4-2/24 Phased Array C7-3/50 Convex SA3-1/24 Phased Array MC9-4/12 Microconvex PA4-2/20 Phased Array PA7-4 Phased Array L9-4/38 Linear C5-2/60 and C5-2/60 GPS Convex EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity L14-5/38 and L14-5/38 GPS Linear {7}------------------------------------------------ ### Page 2 - Mr. Mark Job | C5-2/40 Convex | L14-5W/60 Wide Linear | |-----------------------------------------------|---------------------------------------------| | L15-8/26 Linear | 4DEC9-5/10 Motorized Microconvex Endocavity | | BPSL9-5/55-10L Linear Endocavity Biplane | T7-4 Transesophageal Phased Array | | BPSL9-5/55-10C Microconvex Endocavity Biplane | TEM7-3/9 Transesophageal | | HST15-8/20 Linear | TEM10-7/5 Transesophageal | | 4DC7-3/40 Motorized Convex | TEEIMA Transesophageal | | 4DL14-5/38 Motorized Linear | IOT9-5/40 Convex Intraoperational | If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This 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. {8}------------------------------------------------ Page 3 - Mr. Mark Job If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at (301) 796-6542. Sincerely yours, Arzu M. Whay ריין 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: Sonix Ultrasound Scanner Indications For Use: The Sonix Ultrasound Scanner is intended for the following applications: Ophthalmic, Abdominal, Intraoperative (specific), Intraoperative Cardiac, Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Boock, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that mpnvide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Prescription Use X (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) --- (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K093462 Page 1 of {10}------------------------------------------------ ### Sonix Ultrasound Scanner - Diagnostic Ultrasound Indications for Use Form ### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------| | Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] | | Ophthalmic | N | N | N | N | N | N | N | N[3-6,8] | | Feta! | P | P | P | N | P | P | P | P[6-8] N[3-5,11] | | Abdominal | P | P | P | P | P | P | P | P[6-8] N[3-5,11] | | Intraoperative1 | P | P | P | P | P | P | P | P[6,7] N[3-5,8] | | Intraoperative Neurological | P | P | P | P | P | P | P | P[6,7] N[3-5,8] | | Pediatric | P | P | P | P | P | P | P | P[6-8] N[3-5,11] | | Small Organ2 | P | P | P | N | P | P | P | P[6-8] N[3-5,11] | | Neonatal Cephalic | P | P | P | N | P | P | P | P[3-6,8] N[11] | | Adult Cephalic | P | P | P | N | P | P | P | P[3-6,8] N[11] | | Cardiac | P | P | P | P | P | P | P | P[3-6,8] | | Transesophageal | P | P | P | N | P | P | P | P[3-6,8] | | Transrectal | P | P | P | N | P | P | P | P[6-8] N[3-5,11] | | Transvaginal | P | P | P | N | P | P | P | P[6-8] N[3-5,11] | | Transurethral | | | | | | | | | | Transcranial | P | P | P | N | P | P | P | P[3-6,8] | | Peripheral Vascular | P | P | P | N | P | P | P | P[6-8] N[3-5,11] | | Laparoscopic | | | | | | | | | | MSK Conventional | P | P | P | N | P | P | P | P[6-8] N[3-5,11] | | MSK Superficial | P | P | P | N | P | P | P | P[6-8] N[3-5,11] | | Vascular Access | N | N | N | N | N | N | N | N[3-8,10,11] | | Nerve Block | N | N | N | N | N | N | N | N[3-9,11] | | Other | | | | | | | | | ### N = New indication; P = Previously cleared under K061827 Notes: - 1 Abdominal organs and vascular Breast, Thyrold, Testicle 2 - Elastography 3 - ব Panoramic Imaging 5 Compound Imaging Freehand 3D Imaging 6 7 Live 3D/4D Imaging 8 , Imaging for guidance of blopsy டு Imaging for guidance of nerve block injections 10 Imaging for guldance of central or peripheral lines Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 11 B/M, B/PW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler 1 ![image](image) (Division Si Division of Reproductive, Abdominal, and Radiological De 510(k) Number {11}------------------------------------------------ ### . SA4-2/24 Phased Array Transducer Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|--| | Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] | | | Ophthalmic | | | | | | | | | | | Fetal | | | | | | | | | | | Abdominal | N | N | N | N | N | N | N | N[3-6,8] | | | Intraoperative1 | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | Pediatric | N | N | N | N | N | N | N | N[3-6,8] | | | Small Organ2 | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | N | N | N[3-6,8] | | | Adult Cephalic | N | N | N | N | N | N | N | N[3-6,8] | | | Cardiac | N | N | N | N | N | N | N | N[3-6,8] | | | Transesophageal | | | | | | | | | | | Transrectal | | | | | | | | | | | Transvaginal | | | | | | | | | | | Transurethral | | | | | | | | | | | Transcranial | N | N | N | N | N | N | N | N[3-6,8] | | | Peripheral Vascular | | | | | | | | | | | Laparoscopic | | | | | | | | | | | MSK Conventional | | | | | | | | | | | MSK Superficial | | | | | | | | | | | Vascular Access | | | | | | | | | | | Nerve Block | | | | | | | | | | | Other | | | | | | | | | | N = New indication; P = Previously cleared #### Notes: - Abdominal organs and vascular 1 - 2 Breast, Thyrold, Testicle - 3 Elastography - Panoramic Imaging 4 - 5 Compound Imaging - க Freehand 3D Imaging - 7 Live 3D/4D Imaging - 8 Imaging for guidance of blopsy - g - Imaging for guidance of nerve block injections 10 Imaging for guidance of cantral or peripheral lines - 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). BIM, BIPW Dopler or CW Dopler, of Crevillone in Crisit of CH Dopler (Triplex CW), BPower Doppler/PW Doppler or CW Dopler, Simultageum Color Deven Deselec 12 Doppler, Simultaneous Color Doppler or Power Doppler Appendix C: Transdcuer Specifications 2 SONIX User Manual Lorn Th Nhg (Division Sigr Division of Reproductive, Abdomi and Radiological Devi 510(k) Number 510(k) Number_ {12}------------------------------------------------ # SA3-1/24 Phased Array Transducer # Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------| | | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] | | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | N | N | N | N | N | N | N | N[3-6,8] | | Intraoperative1 | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | Pediatric | N | N | N | N | N | N | N | N[3-6,8] | | Small Organ2 | | | | | | | | | | Neonatal Cephalic | N | N | N | | N | N | N | N[3-6,8] | | Adult Cephalic | N | N | N | N | N | N | N | N[3-6,8] | | Cardiac | N | N | N | N | N | N | N | N[3-6,8] | | Transesophageal | | | | | | | | | | Transrectal | | | | | | | | | | Transvaginal | | | | | | | | | | Transurethral | | | | | | | | | | Transcranial | N | N | N | N | N | N | N | N[3-6,8] | | Peripheral Vascular | | | | | | | | | | Laparoscopic | | | | | | | | | | MSK Conventional | | | | | | | | | | MSK Superficial | | | | | | | | | | Vascular Access | | | | | | | | | | Nerve Block | | | | | | | | | | Other | | | | | | | | | N = New indication; P = Previously cleared Notes: Abdominal organs and vascular t Breast, Thyrold, Testicle 2 3 Elastography Panoramic Imaging 4 Compound Imaging ર 6 Freehand 3D Imaging 7 Live 3D/4D Imaging lmaging for guldance of biopsy 8 a Imaging for guidance of nerve block Injections 10 lmaging for guidance of central or peripheral lines 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). Polling Nation Pingle Pusion of State Printer the GFS transdicer). BM, BPW Dopler or CW Dopler (Triplex) or CW Dopler (Triplex CW), BiPower Dopler/PW Dopler or CW Dopler, 12 Doppler, Simultaneous Color Doppler or Power Doppler 3 SONIX User Manual Appendix C: Transducer Specifications Tony M. Whig (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number K093462 {13}------------------------------------------------ # PA4-2/20 Phased Array Transducer # Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | Other<br>[Notes] | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|---------------|------------------| | | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | | | | Ophthalmic | | | | | | | | | | | Fetal | | | | | | | | | | | Abdominal | P | P | P | P | P | P | P | P[6] N[3-5,8] | | | Intraoperative1 | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | P[6] N[3-5,8] | | | Small Organ2 | | | | | | | | | | | Neonatal Cephalic | P | P | P | P | P | P | P | P[6] N[3-5,8] | | | Adult Cephalic | P | P | P | N | P | P | P | P[6] N[3-5,8] | | | Cardiac | P | P | P | P | P | P | P | P[6] N[3-5,8] | | | Transesophageal | | | | | | | | | | | Transrectal | | | | | | | | | | | Transvaginal | | | | | | | | | | | Transurethral | | | | | | | | | | | Transcranial | P | P | P | N | P | P | P | P[6] N[3-5,8] | | | Peripheral Vascular | | | | | | | | | | | Laparoscopic | | | | | | | | | | | MSK Conventional | | | | | | | | | | | MSK Superficial | | | | | | | | | | | Vascular Access | | | | | | | | | | | Nerve Block | | | | | | | | | | | Other | | | | | | | | | | N = New indication; P = Previously cleared under K061827 Notes: - 1 Abdominal organs and vascular - Breast, Thyroid, Testicle 2 - Elastography ਤ - 4 Panoramic Imaging - 5 Compound Imaging - ট Freehand 3D Imaging - 7 Live 3D/4D Imaging - lmaging for guldance of biopsy 8 - 9 Imaging for guldance of nerve block injections - 10 Imaging for guidance of central or peripheral lines - 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). - BIM, BIPW Doppler, BIC/PW Doppler, B/C/PW Doppler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler 4 Appendix C: Transdcuer Specifications SONIX User Manual Tony M. Whay (Division Sign Division of Reproductive, and Radiological Devi 510(k) Number {14}------------------------------------------------ ### PA7-4 Phased Array Transducer # Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------| | | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] | | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | P | P | P | P | P | P | P | P[6] N[3-5,8] | | Intraoperative1 | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | P[6] N[3-5,8] | | Small Organ2 | | | | | | | | | | Neonatal Cephalic | P | P | P | | P | P | P | P[6] N[3-5,8] | | Adult Cephalic | P | P | P | N | P | P | P | P[6] N[3-5,8] | | Cardiac | P | P | P | P | P | P | P | P[6] N[3-5,8] | | Transesophageal | | | | | | | | | | Transrectal | | | | | | | | | | Transvaginal | | | | | | | | | | Transurethral | | | | | | | | | | Transcranial | P | P | P | N | P | P | P | P[6] N[3-5,8] | | Peripheral Vascular | | | | | | | | | | Laparoscopic | | | | | | | | | | MSK Conventional | | | | | | | | | | MSK Superficial | | | | | | | | | | Vascular Access | | | | | | | | | | Nerve Block | | | | | | | | | | Other | | | | | | | | | # N = New indication; P = Previously cleared under K061827 #### Notes: - 1 Abdominal organs and vascular - Breast, Thyrold, Testicle 2 - Elastography 3 - র্ণ Panoramic Imaging - 5 Compound Imaging - Freehand 3D Imaging රි - 7 Live 3D/4D Imaging - 8 Imaging for guldance of biopsy - ರಿ Imaging for guidance of nerve block injections - 10 Imaging for guidance of central or peripheral lines - 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). B/M, B/PW Dopler or CW Dopler (T/C/PW Dopler (Triplex) or C Guillousel). Donaler Simulaneous Color Dopler (Tiplex) or CW Dopler (Triplex CW), B/Power Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppler SONIX User Manual Prescription Use Only 5 louis to wh (Division S Division of Reproductive, Abdominal and Radiological De 510(k) Number Appendix C: Transdcuer Specifications {15}------------------------------------------------ # C5-2/60 and C5-2/60 GPS Convex Transducers # Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | Other<br>[Notes] | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------|------------------| | | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | | | | Ophthalmic | | | | | | | | | | | Fetal | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | | Abdominal | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | | Intraoperative¹ | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | Pediatric | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | | Small Organ2 | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Cardiac | | | | | | | | | | | Transesophageal | | | | | | | | | | | Transrectal | | | | | | | | | | | Transvaginal | | | | | | | | | | | Transurethral | | | | | | | | | | | Transcranial | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | | Laparoscopic | | | | | | | | | | | MSK Conventional | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | | MSK Superficial | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | | Vascular Access | | | | | | | | | | | Nerve Block | | | | | | | | | | | Other | | | | | | | | | | N = New indication; P = Previously cleared under K061827 Notes: - Abdominal organs and vascular 1 2 Breast, Thyrold, Testicle - 3 Elastography - Panoramic Imaging 4 - ર Compound Imaging - க Freehand 3D Imaging - Live 3D/4D Imaging 7 - 8 lmaging for guidance of biopsy - 9 lmaging for guldance of nerve block injections 10 Imaging for guidance of central or peripheral lines 11 Volume Navigation / Image Fuslon / GPS (available only with the GPS transducer). entiller de light of Color of O Quiliado only with of GT ST Gransdoel). BM, BPW Doppler of CW Dopler BVCPW Dopler (Triplex) or CW Doppler (Triplex CW), BPower Dopler/PW Dopp e Appendix C: Transdcuer Specifications SONIX User Manual loris M. White (Division S ign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number {16}------------------------------------------------ ### C5-2/40 Convex Transducer # Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | Other<br>[Notes] | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|---------------|------------------| | | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | | | | Ophthalmic | | | | | | | | | | | Fetal | P | P | P | | P | P | P | P[6] N[3-5,8] | | | Abdominal | P | P | P | | P | P | P | P[6] N[3-5,8] | | | Intraoperative1 | P | P | P | | | | | | | | Intraoperative Neurological | | | | | | | | | | | Pediatric | P | P | P | | P | P | P | P[6] N[3-5,8] | | | Small Organ2 | P | P | P | | P | P | P | P[6] N[3-5,8] | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Cardiac | | | | | | | | | | | Transesophageal | | | | | | | | | | | Transrectal | | | | | | | | | | | Transvaginal | | | | | | | | | | | Transurethral | | | | | | | | | | | Transcranial | | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P[6] N[3-5,8] | | | Laparoscopic | | | | | | | | | | | MSK Conventional | P | P | P | | P | P | P | P[6] N[3-5,8] | | | MSK Superficial | P | P | P | | P | P | P | P[6] N[3-5,8] | | | Vascular Access | | | | | | | | | | | Nerve Block | | | | | | | | | | | Other | | | | | | | | | | N = New indication; P = Previously cleared under K061827 . #### Notes: - Abdominal organs and vascular 1 - 2 Breast, Thyroid, Testicle - Elastography 3 - 4 Panoramic Imaging - ર Compound Imaging - Freehand 3D Imaging 6 - 7 Live 3D/4D Imaging - 8 Imaging for guldance of biopsy - 8 Imaging for guidance of nerve block injections - Imaging for guidance of central or peripheral lines 10 - 11 - Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 12 BM, B/W Dopler on CW Dopler (Thile GP S Valisuce). B/M, B/PW Dopler on CW Dopler (Thplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW Dopler, Slimultaneous Doppler, Simultaneous Color Doppler or Power Doppler 7 SONIX User Manual Appendix C: Transducer Specifications Lurpi Th. Wh. (Divisio -Off Division of Reproductive, Abdominal and Radiological Dev 510(k) Number {17}------------------------------------------------ ### C7-3/50 Convex Transducer Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------| | Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] | | Ophthalmic | | | | | | | | | | Fetal | P | P | P | | P | P | P | P[6,8] N[3-5] | | Abdominal | P | P | P | | P | P | P | P[6,8] N[3-5] | | Intraoperative1 | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | Pediatric | P | P | P | | P | P | P | P[6,8] N[3-5] | | Small Organ2 | P | P | P | | P | P | P | P[6,8] N[3-5] | | Neonatal Cephalic | P | P | P | | P | P | P | P[6,8] N[3-5] | | Adult Cephalic | P | P | P | | P | P | P | P[6.8] N[3-5] | | Cardiac | | | | | | | | | | Transesophageal | | | | | | | | | | Transrectal | | | | | | | | | | Transvaginal | | | | | | | | | | Transurethral | | | | | | | | | | Transcranial | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P[6,8] N[3-5] | | Laparoscopic | | | | | | | | | | MSK Conventional | P | P | P | | P | P | P | P[6,8] N[3-5] | | MSK Superficial | P | P | P | | P | P | P | P[6,8] N[3-5] | | Vascular Access | | | | | | | | | | Nerve Block | | | | | | | | | | Other | | | | | | | | | N = New indication; P = Previously cleared under K061827 Notes: - 1 Abdominal organs and vascular - Breast, Thyrold, Testicle 2 - 3 Elastography - 4 Panoramic Imaging - 5 Compound Imaging - ર Freehand 3D Imaging - 7 Live 3D/4D Imaging - 8 Imaging for guidance of blopsy - છે - Imaging for guidance of nerve block Injections 10 - imaging for guidance of central or peripheral lines - 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). BM, BPW Dopler or CW Dopler, DV QVW Dopler (Thplex) or CV Dopler (Triplex CW), BiPower Doppler)PW Doppler or CW 12 Doppler, Simultaneous Color Doppler or Power Doppier Appendix C: Transdcuer Specifications 8 SONIX User Manual Prescription Use Only Lina M. Whig (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number 10(k) Number {18}------------------------------------------------ ### MC9-4/12 Microconvex Transducer # Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------| | | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] | | Ophthalmic | | | | | | | | | | Fetal | N | N | N | N | N | N | N | N[3-6,8] | | Abdominal | N | N | N | N | N | N | N | N[3-6,8] | | Intraoperative1 | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | Pediatric | N | N | N | N | N | N | N | N[3-6,8] | | Small Organ2 | N | N | N | N | N | N | N | N[3-6,8] | | Neonatal Cephalic | N | N | N | N | N | N | N | N[3-6,8] | | Adult Cephalic | N | N | N | N | N | N | N | N[3-6,8] | | Cardiac | | | | | | | | | | Transesophageal | | | | | | | | | | Transrectal | | | | | | | | | | Transvaginal | | | | | | | | | | Transurethral | | | | | | | | | | Transcranial | N | N | N | N | N | N | N | N[3-6,8] | | Peripheral Vascular | N | N | N | N | N | N | N | N[3-6,8] | | Laparoscopic | | | | | | | | | | MSK Conventional | N | N | N | N | N | N | N | N[3-6,8] | | MSK Superficial | N | N | N | N | N | N | N | N[3-6,8] | | Vascular Access | N | N | N | N | N | N | N | N[3-6,8,10] | | Nerve Block | N | N | N | N | N | N | N | N[3-6,8,9] | | Other | | | | | | | | | N = New indication; P = Previously cleared Notes: - Abdominal organs and vascular 1 2 Breast, Thyroid, Testicle - Elastography 3 - র্ব Panoramic Imaging - 5 Compound imaging - 6 Freehand 3D Imaging - 7 Live 3D/4D Imaging - 8 Imaging for guidance of blopsy - 9 Imaging for guidance of nerve block injections - 10 Imaging for guidance of central or peripheral lines - 11 · Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). 12 Birling of Children and Co (C) (Charles on J misro of O Guiladoor). BiM, BiPW Dopler of CW Dopler, B/C/PW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler 9 SONIX User Manual Appendix C: Transdcuer Specifications (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological De 510(k) Number {19}------------------------------------------------ # EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity Transducers Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------| | | 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[6,8] N[3-5,11] | | Transvaginal | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | Transurethral | | | | | | | | | | Transcranial | | | | | | | | | | Peripheral Vascular | | | | | | | | | | Laparoscopic | | | | | | | | | | MSK Conventional | | | | | | | | | | MSK Superficial | | | | | | | | | | Vascular Access | | | | | | | | | | Nerve Block | | | | | | | | | | Other | | | | | | | | | N = New indication; P = Previously cleared under K061827 Notes : - Abdominal organs and vascular 1 - 2 Breast, Thyroid, Testicle - 3 Elastography - Panoramic Imaging 4 - ર Compound Imaging - 6 Freehand 3D Imaging - Live 3D/4D Imaging 7 - 8 Imaging for guidance of biopsy - റ്റ - lmaging for guidance of nerve block injections 10 I maging for guidance of central or peripheral lines - - 11 Villame Navigation / Image Fusion / GPS (available only with the GPS transducer). - 12 BM, BPW Dopler of GM Dopler (Triplex) on Other only Started on Chinadoe). 12 BM, BPW Dopler CW Dopler (Triplex) or CW Dopler (Triplex CVV), BPower Dopler of CW Doppler Appendix C: Transdcuer Specifications 10 SONIX User Manual Lopes In Whys (Division Sign Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number {20}------------------------------------------------ ### L9-4/38 Linear Transducer # Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------| | | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] | | Ophthalmic | | | | | | | | | | Fetal | P | P | P | | P | P | P | P[6,8] N[3-5] | | Abdominal | P | P | P | | P | P | P | P[6,8] N[3-5] | | Intraoperative1 | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | Pediatric | P | P | P | | P | P | P | P[6,8] N[3-5] | | Small Organ2 | P | P | P | | P | P | P | P[6,8] N[3-5] | | Neonatal Cephalic | P | P | P | | P | P | P | P[6,8] N[3-5] | | Adult Cephalic | P | P | P | | P | P | P | P[6,8] N[3-5] | | Cardiac | | | | | | | | | | Transesophageal | | | | | | | | | | Transrectal | | | | | | | | | | Transvaginal | | | | | | | | | | Transurethral | | | | | | | | | | Transcranial | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P[6,8] N[3-5] | | Laparoscopic | | | | | | | | | | MSK Conventional | P | P | P | | P | P | P | P[6,8] N[3-5] | | MSK Superficial | P | P | P | | P | P | P | P[6,8] N[3-5] | | Vascular Access | N | N | N | | N | N | N | N[3-6,8,10] | | Nerve Block | N | N | N | | N | N | N | N[3-6,8,9] | | Other | | | | | | | | | ### N = New indication; P = Previously cleared under K061827 #### Notes: - Abdominal organs and vascular 1 - Breast, Thyroid, Testicle 2 - 3 Elastography - 4 Panoramic Imaging - 5 Compound Imaging - ക Freehand 3D Imaging - 7 Live 3D/4D Imaging - 8 Imaging for guidance of biopsy - ଚ୍ଚ Imaging for guidance of nerve block injections - 10 I maging for guidance of central or peripheral lines - 11 Volume Navigation / Image Fusion / GPS (available only with the GPS transducer). - 12 BM, BPW Doppler, M. GV (Dr.) 20 (Clumbon) Strip Marian Chi) (Triplex CW), B/Power Dopler/PW Dopler/PW Dopler or CW Dopler Simultanova Coler Dopler, B/C/PW Doppler (Triple Doppler, Simultaneous Color Doppler or Power Doppler SONIX User Manual #### Appendix C: Transdcuer Specifications Prescription Use Only louis M. White (Division S Division of Reproductive, Abdominal, and Radiological De 510(k) Number 11 ( {21}------------------------------------------------ ### L14-5/38 and L14-5/38 GPS Linear Transducers Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|---------------------|------------------| | | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes12 | Other<br>[Notes] | | Ophthalmic | | | | | | | | | | Fetal | P | P | P | P | P | P | P[6,8] N[3-5,11] | | | Abdominal | P | P | P | P | P | P | P[6,8] N[3-5,11] | | | Intraoperative1 | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | Pediatric | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | Small Organ2 | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | Neonatal Cephalic | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | Adult Cephalic | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | Cardiac | | | | | | | | | | Transesophageal | | | | | | | | | | Transrectal | | | | | | | | | | Transvaginal | | | | | | | | | | Transurethral | | | | | | | | | | Transcranial | | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | P[6,8] N[3-5,11] | | Laparoscopic | | | | | | | | | | MSK Conventional | P | P | P | | P | P |…
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