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K Number
K102997
Device Name
SONIXTABLET ULTRASOUND SCANNER
Manufacturer
UltraSonix Medical Corporation
Date Cleared
2010-12-21

(75 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, 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 Description
The SonixTABLET Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode. 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 optional electrocardiography (ECG) display feature and support for a 3lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased arrav scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the SonixTABLET Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.
More Information

K093462, K083095, K080935

K093462, K083095, K080935

No
The document does not mention AI, ML, or related terms like deep learning or neural networks in the device description or other sections. The description focuses on standard ultrasound imaging modes and features.

No
The device is described as an "Ultrasound Imaging System" intended for diagnostic purposes, such as "clinical diagnosis" and "acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode." There is no mention of it providing therapy.

Yes

The "Intended Use / Indications for Use" section explicitly states that the system provides "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." Additionally, the "Device Description" identifies it as a "software controlled diagnostic ultrasound system." The "Mentions image processing" also states, "The backend processing is also similar to the predicate devices and yields an ultrasound image in realtime for diagnosis purposes."

No

The device description explicitly mentions hardware components such as a "multi-purpose mobile, software controlled diagnostic ultrasound system," "Flat Panel Display," "computer keyboard," "touch panel," "ECG cable assembly," and "probes." It also describes physical accessories like "biopsy kits" made of "polymeric bracket" and "needle guides." These are all physical components, not solely software.

Based on the provided information, the SonixTABLET Ultrasound Imaging System is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • SonixTABLET Function: The SonixTABLET is an ultrasound imaging system. It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
  • Intended Use: The intended uses listed are all related to imaging internal anatomical structures and providing measurements and calculations based on those images. These are typical applications for an ultrasound system.
  • Device Description: The description details the hardware and software components of an ultrasound scanner, including probes, display modes, measurement capabilities, and image storage. None of these components or functions are related to analyzing samples taken from the body.

Therefore, the SonixTABLET Ultrasound Imaging System falls under the category of medical imaging devices, not in vitro diagnostic devices.

N/A

Intended Use / Indications for Use

The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, 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.

Product codes

90-IYN, 90-IYO, 90-ITX

Device Description

The SonixTABLET Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode. 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 optional electrocardiography (ECG) display feature and support for a 3lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased arrav scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the SonixTABLET Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial

Indicated Patient Age Range

Neonatal / Adult Cephalic (implies use for neonates and adults), Fetal, Pediatric

Intended User / Care Setting

Clinician, Physician. The mention of "mobile" system suggests use in various clinical settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Sonix Ultrasound Scanner (K093462), Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

0

K102997

510 (k) Summary for the SonixTABLET Ultrasound Scanner

DEC 2 1 2010

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 2009 revision to 21 CFR, Part 807.92, Content and format of a 510(k) summary.

1.0 Submitter Information

1.1 Submitter

Ultrasonix Medical Corporation 130-4311 Viking Way Richmond, British Columbia Canada V6V 2K9 (t) 604-279-8550 (f) 604-279-8559

1.2 Contact

Chas Yu, Quality Assurance Manager (t) 604-279-8550 x 152 (f) 604-279-8559 (e) chas.yu@ultrasonix.com

1.3 Date Prepared

July 31, 2010

2.0 Device Name

2.1 Common Name

Ultrasound Imaging System

2.2 Proprietary Name

SonixTABLET Ultrasound Scanner

2.3 Classification Name

FR NumberProduct Code
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasonic Pulsed Echo Imaging System892.156090-IYO
Diagnostic Ultrasound Transducer892.157090-ITX

1

2.4 Classification

Class II

2.5 Predicate Device:

Sonix Ultrasound Scanner (K093462) Sonix TOUCH Ultrasound Scanner (K083095) SONIX MDP Ultrasound Scanner (K080935)

2.6 Reason for submission:

Name change request

n/A

2

New product clearance for:

SonixTABLET Ultrasound Scanner

Supporting Transducers:

  • 4DC7-3/40 .
  • 4DEC9-5/10 .
  • . 4DL14-5/38
  • BPL9-5/55 .
  • . BPC8-4/10
  • C5-2/60 .
  • . C5-2/60 GPS
  • C7-3/50 .
  • . MC9-4/12
  • . EC9-5/10
  • EC9-5/10 GPS .
  • HST15-8/20 .
  • 19-4/38 .
  • . L14-5/38
  • L14-5/38 GPS .
  • L14-5W/60 .
  • . PA7-4/12
  • SA4-2/24 .
  • . mTEE8-3/5

3

2.7 Device description

The SonixTABLET Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode. 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 optional electrocardiography (ECG) display feature and support for a 3lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased arrav scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the SonixTABLET Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

Frequency Range2-40MHz
Transducer typesLinear array
Curved array
TEE array
Intracavity array
Phased array

4

The SonixTABLET Ultrasound Scanner is designed to comply with the following standards and the system follows Track 3.

| Reference
Number | Title | FDA Recognition
Number |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| IEC 60601-1 | IEC 60601-1, Medical Electrical Equipment - Part 1: General
Requirements for Safety, 1988; Amendment 1, 1991-11,
Amendment 2, 1995. | 5-4 |
| IEC 60601-1-2 | IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral standard: Electromagnetic
Compatibility - Requirements and Tests (Edition 2:2001 with
Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated
with Amendment 1:2004)). | 5-34 |
| AIUM AOL | Acoustic Output Labeling Standard for Diagnostic Ultrasound
Equipment Revision 1 - A standard for How Manufacturers
Should Specify Acoustic Output Data | 12-193 |
| AIUM RTD1-
2004 | Standard for Real - Time Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic Ultrasound Equipment
Revision 1 | 12-140 |

3.0 Summary of Intended Uses

.

The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

5

4.0 Comparison to Predicate Device

The SonixTABLET Ultrasound Scanner is substantially equivalent to the predicate devices listed below with respect to intended use/indications for use, principles of operation and technological characteristics.

The SonixTABLET Ultrasound Scanner includes a digital beamformer that is similar in function to the predicate devices beamformer. It allows transmitting and receiving signals through the ultrasound transducers. The ultrasound transducers are similar to the ones used on predicate devices.

The backend processing is also similar to the predicate devices and yields an ultrasound image in realtime for diagnosis purposes.

Sonix Ultrasound Scanner (K093462) Sonix TOUCH Ultrasound Scanner (K083095) Sonix MDP Ultrasound Scanner (K080935)

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

6.0 Safety considerations

As track 3 ultrasound device, the SonixTABLET Ultrasound Scanner is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (2004)" published by the National Electrical Manufacturers Association as UD-3.

With respect to limits on acoustic outputs, the SonixTABLET Ultrasound Scanner complies with the guideline limits set in the September 9, 2008 revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the SonixTABLET Ultrasound Scanner is designed to comply with IEC 60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601-2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.

The devices' acoustic output limits are:

ISPTA (d)720mW/cm²
TIS/TIB/TIC0.1 - 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

Image /page/7/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, yet conveys the department's mission of promoting the health and well-being of the nation.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

DEC 2 1 2010

Ultrasonix Medical Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K102997

Trade/Device Name: SonixTABLET Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 3, 2010 Received: December 6, 2010

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 SonixTABLET Ultrasound Scanner, as described in your premarket notification:

Transducer Model Number

4DC7-3/40 Motorized Convex Radius 4DEC9-5/10 Motorized Microconvex Endocavity Radius 4DL14-5/38 Motorized Linear BPL9-5/55 Linear Biplane BPC8-4/10 Microconvex Endocavity Biplane C5-2/60 and C5-2/60 GPS Convex C7-3/50 Convex MC9-4/12 Microconvex EC9-5/10 AND EC9-5/10 GPS Microconvex Endocavity Radius

8

HST15-8/20 Linear L9-4/38 Linear L14-5/38 AND L14-5/38 GPS Linear L14-5W60 Wide Linear PA7-4/12 Phased Array SA4-2/24 Phased Array mTEE8-3/5 Transesophageal Phased Array Radius

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification, The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours,

Bavid G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

9

Indications for Use

510(k) Number (if known): Device Name: SonixTABLET Ultrasound Scanner Indications For Use:

The SonixTABLET Ultrasound Scanner is intended for the following applications: Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Abdominal. 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, transrectal, 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 Dovice Evaluation 400E) OLV O

(Division Sign-Off)

Page 1 of 1

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102097

10

SONIXTABLET ULTRASOUND SCANNER

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes12 | Other
[Notes] |
|-----------------------------|---|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | | N | N | N | N [3-8,11] |
| Abdominal | N | N | N | N | N | N | N | N [3-8,11] |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | N | N | N | | N | N | N | N [3-6,8] |
| Pediatric | N | N | N | N | N | N | N | N [3-8,11] |
| Small Organ2 | N | N | N | | N | N | N | N [3-8,11] |
| Neonatal Cephalic | N | N | N | | N | N | N | N [3-6,8,11] |
| Adult Cephalic | N | N | N | N | N | N | N | N [3-6,8,11] |
| Cardiac | N | N | N | N | N | N | N | N [3-6,8,11] |
| Transesophageal | N | N | N | N | N | N | N | |
| Transrectal | N | N | N | N | N | N | N | N [3-8,11] |
| Transvaginal | N | N | N | | N | N | N | N [3-8,11] |
| Transurethral | | | | | | | | |
| Transcranial | N | N | N | N | N | N | N | N [3-6,8] |
| Peripheral Vascular | N | N | N | | N | N | N | N [3-6,8,10,11] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | N | N | N | | N | N | N | N [3-8,11] |
| MSK Superficial | N | N | N | | N | N | N | N [3-8,11] |
| Vascular Access | N | N | N | | N | N | N | N [3-8,10,11] |
| Nerve Block` | N | N | N | | N | N | N | N [3-6,8-9,11] |
| Other | | | | | | | | |

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication

Notes:

  • Abdominal organs and vascular 1.
  • Breast, Thyroid, Testicle 2.

Elastography 3.

  • ধ : Panoramic Imaging
  • ડે. Compound Imaging
  • Freehand 3D Imaging 6.

7, Live 3D/4D Imaging

    1. Imaging for guidance of biopsy

  1. Imaging for guidance of nerve block injections

  2. Imaging for guidance of central or peripheral lines

  3. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transducers)

  4. Imaging to gridance of central ines

  5. Inajng for gridentels (2010) Sonts PS (avaiable only with the GPS transduces)

  6. Blank (2010) Simultaneous Color Doppler or Power Doppler.

1

Prescription Use Only

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K10.2997

11

4DC7-3/40 Motorized Convex Radius Transducer

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalmic
FetalPPPPPPP [3-8]
AbdominalPPPPPPP [3-8]
Intraoperative1
Intraoperative Neurological
PediatricPPPPPPP [3-8]
Small Organ2PPPPPPP [3-8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK ConventionalPPPPPPP [3-8]
MSK SuperficialPPPPPPP [3-8]
Vascular Access
Nerve Block
Other

l tended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

    1. Abdominal organs and vascular
  • Breast, Thyroid, Testicle in
  • Elastography 3.
  • র্বা Panoramic Imaging
  • ഗ് Compound Imaging
  • Freehand 3D Imaging ર.
    1. Live 3D/4D Imaging
  • Imaging for guidance of biopsy 8.
  • ക് Imaging for guidance of nerve block injections
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transducers)
    1. BM, BPW Doppler, or CW Dopler, DCCPV (prairies) or CW Dopler (Triplex CW), BPower Doppler/W Dopler or CW Dopler, or CW Dopler, Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

.

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102997

12

diagnostic ultrasound indications for use form

4DEC9-5/10 Motorized Microconvex Endocavity Radius Transducer

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes 12 | Other
[Notes] |
|-----------------------------|------------|---|---------------|---------------|------------------|------------------|----------------------|------------------|
| | Ophthalmic | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal1 | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ2 | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P [3-8] |
| Transvaginal | P | P | P | | P | P | P | P [3-8] |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |

Intended use: Diagnostic ultrasound imaging or fuid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

  • Abdominal organs and vascular 1.
  • ર્પ Breast, Thyroid, Testicle
  1. Elastography
  • Panoramic Imaging 4.
    Compound Imaging 5.

Freehand 3D Imaging

Live 3D/4D Imaging 7.

lmaging for guidance of biopsy 8.

Imaging for guidance of nerve block injections ப்

  1. Imaging for guidance of central or peripheral lines

  2. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transduc

or in maging on central of Bellpheil Mes
11. Volume Nevigationings Pusialbe only wib the GPS transduce)
12. Birane Vavigation of CV Dopler (Tiplex) or CW Dopler (Triple Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

Signature

(Division Sign-Off) Division of Radiological Devices - Bivision of Haulorogical Devices
Vitro Diagnostic Device Evaluation and Safety Office of In

510K K162997

చు

13

4DL14-5/38 Motorized Linear Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalmic
Fetal
AbdominalPPPPPPP [3-8]
Intraoperative1
Intraoperative Neurological
PediatricPPPPPPP [3-8]
Small Organ2PPPPPPP [3-8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK ConventionalPPPPPPP [3-8]
MSK SuperficialPPPPPPP [3-8]
Vascular AccessPPPPPPP [3-8,10]
Nerve BlockPPPPPPP [3-9]

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes :

    1. Abdominal organs and vascular
    1. Breast, Thyroid, Testicle
  • Elastography 3.
  • Panoramic Imaging 4.
  • રું. Compound Imaging
    1. Freehand 3D Imaging
    1. Live 3D/4D Imaging
  • Imaging for guidance of biopsy 8.
  • Imaging for guidance of nerve block injections ഗ്
    1. Imaging for guidance of central or peripheral lines
  • e of the light a gained of Schilder his
  1. Volume Nagatine or Childs on Polyer (Triplex) on CW Dopter (Triplex CW), BPower Doppler or CW Dopler or CW Dopler or C Simultaneous Color Doppler or Power Dopplar.

4

Prescription Use Only

(Division Sign-Off) Division of Radiological Devices Ditice of In Vitro Diagnostic Device Evaluation and Safety

510K K162997

14

BPL9-5/55 Linear Endocavity Biplane Transducer

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes 12Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative 1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPPPP [3-6,8]
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

  • Abdominal organs and vascular 1.
  • Breast, Thyroid, Testicle 2.
    1. Elastography
  • ব . Panoramic Imaging
    1. Compound Imaging
  • Freehand 3D Imaging 6.
  • Live 3D/4D Imaging 7.
    1. Imaging for guidance of biopsy
  • റ്റ് Imaging for guidance of nerve block injections
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/Knage Fusion/SonixGPS™ (available only with the GPS transducer)
    1. BIM, BIPW Dopler or CW Dopler (Tiplex) or CW Dopler (Tiplex CW), B/Power Doppler/PW Doppler or CW Dopler or CW Dopler, Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

signature

(Division Sign-Off) Division of Radiological Devices ice Evaluation and Safety Office of In

510K K162997

15

BPC8-4/10 Microconvex Endocavity Biplane Transducer

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes 12Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative'
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPPPP (3-6,8)
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

    1. Abdominal organs and vascular
    1. Breast, Thyroid, Testicle
    1. Elastography
    1. Panoramic Imaging
  • Compound Imaging 5.
  • Freehand 3D Imaging 6.
  • Live 3D/4D Imaging 7.
    1. Imaging for guidance of biopsy
    1. Imaging for guidance of nerve block injections
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/SonixGPS™ (available only with the GPS transducer)
  1. BM, BPW Dopler or CW Dopler (Tiplex) or CW Dopler (Tiplex CW), BlPower Dopler/PW D Simultaneous Color Doppler or Power Doppler.

STOK

Prescription Use Only

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16

C5-2/60 and C5-2/60 GPS Convex Transducers

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalinic
FetalPPPPPPP [3-6,8,11]
AbdominalPPPPPPP [3-6,8,11]
Intraoperative1
Intraoperative Neurological
PediatricPPPPPPP [3-6,8,11]
Small Organ2PPPPPPP [3-6,8,11]
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP [3-6,8,11]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral VascularPPPPPPP [3-6,8,11]
Laparoscopic'
MSK ConventionalPPPPPPP [3-6,8,11]
MSK SuperficialPPPPPPP [3-6,8,11]
Vascular Access
Nerve Block
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

  • Abdominal organs and vascular 1.
  • Breast, Thyroid, Testicle 2.
  • Elastography 3.
    1. Panoramic Imaging
    1. Compound Imaging
    1. Freehand 3D Imaging
  • Live 3D/4D Imaging 7.
    1. Imaging for guidance of biopsy
  • ல் Imaging for guidance of nerve block injections
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transducer)
    1. B/M, B/PW Doppler or CW Doppler (Triplex) or CW Dopler (Triplex CW), B/Power Doppler/PW Doppler or CW Doppler, Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

(Division Sign-Off)

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510K

17

C7-3/50 Convex Transducer

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalmic
FetalPPPPPPP [3-6,8]
AbdominalPPPPPPP [3-6,8]
Intraoperative1
Intraoperative Neurological
PediatricPPPPPPP [3-6,8]
Small Organ2PPPPPPP [3-6,8]
Neonatal Cephalic
Adult Cephalic
CardiacPPPPPPP [3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral VascularPPPPPPP [3-6,8]
Laparoscopic
MSK ConventionalPPPPPPP [3-6,8]
MSK SuperficialPPPPPPP [3-6,8]
Vascular Access
Nerve Block
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

    1. Abdominal organs and vascular
    1. Breast, Thyroid, Testicle
  • Elastography 3.
  • Panoramic Imaging র্ধ।
  • રું. Compound Imaging
    1. Freehand 3D Imaging
    1. Live 3D/4D Imaging
  1. I lmaging for guidance of biopsy
  • ക് Imaging for guidance of nerve block injectlons
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/lmage Fusion/SonixGPS™ (available only with the GPS transducer)
  • το 1981 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991

8

Prescription Use Only

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Division of Radibiogical Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102997

18

MC9-4/12 Microconvex Transducer

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalmic
Fetal
AbdominalPPPPPPP [3-6,8]
Intraoperative1
Intraoperative Neurological
PediatricPPPPPPP [3-6,8]
Small Organ2PPPPPPP [3-6,8]
Neonatal CephalicPPPPPPP [3-6,8]
Adult CephalicPPPPPPP [3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
TranscranialPPPPPPP [3-6,8]
Peripheral VascularPPPPPPP [3-6,8,10]
Laparoscopic
MSK ConventionalPPPPPPP [3-6,8]
MSK SuperficialPPPPPPP [3-6,8]
Vascular AccessPPPPPPP [3-6,8,10]
Nerve BlockPPPPPPP [3-6,8-9]
Other

lntended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

    1. Abdominal organs and vascular
    1. Breast, Thyroid, Testicle
  • Elastography 3.
  • Panoramic Imaging 4.
    1. Compound Imaging
    1. Freehand 3D Imaging
    1. Live 3D/4D Imaging
    1. Imaging for guidance of biopsy
  • Imaging for guidance of nerve block injections ക്
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/lmage Fusion/SonixGPS™ (available only with the GPS transducer)
    1. BM, BIPW Dopler or CW Dopler (Triplex) or CW Doppler (Triplex CW), B/Power Doppler/PW Dopler or CW Dopler or CW Dopler, Simultaneous Color Doppler or Power Doppler.

9

510K

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Office Of In Vitro Diagnostic Device Evaluation and Safety

19

EC9-5/10 and EC9-5/10 GPS Microconvex Endocavity Radius Transducer

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes12 | Other
[Notes] |
|-----------------------------|---|---|---------------|---------------|------------------|------------------|---------------------|------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ2 | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P [3-6,8,11] |
| Transvaginal | P | P | P | | P | P | P | P [3-6,8,11] |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

    1. Abdominal organs and vascular
  • Breast, Thyroid, Testicle 2.
  • Elastography 3.
    1. Panoramic Imaging
  • ui Compound Imaging
    1. Freehand 3D Imaging
    1. Live 3D/4D Imaging
    1. Imaging for guidance of biopsy
  • ு. Imaging for guidance of nerve block injections
    1. Inaging for guitane of carperal lines
  1. Volme Neigatorillands Frusiable only with the GPS ransduce)
  2. BM, Blevier or OV Dopler or Over (Tiplex) or CW Dopl Simultaneous Color Doppler or Power Doppler.

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Evaluation and Safety

Office of In

210k

Prescription Use Only

20

HST15-8/20 Linear Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative NeurologicalPPPPPPP [3-6,8]
PediatricPPPPPPP [3-6,8]
Small Organ2PPPPPPP [3-6,8]
Neonatal CephalicPPPPPPP [3-6,8]
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
TranscranialPPPPPPP [3-6,8]
Peripheral VascularPPPPPPP [3-6,8]
Laparoscopic
MSK ConventionalPPPPPPP [3-6,8]
MSK SuperficialPPPPPPP [3-6,8]
Vascular AccessPPPPPPP [3-6,8,10]
Nerve BlockPPPPPPP [3-6,8,9]
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

. .

  • Abdominal organs and vascular ﻬﺎ
  • Breast, Thyroid, Testicle 2.
    1. Elastography
    1. Panoramic Imaging
  • Compound Imaging 5.
  • Freehand 3D Imaging 6.
  • Live 3D/4D Imaging 7.
  • రి. Imaging for guidance of biopsy
  • g. Imaging for guidance of nerve block injections
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transducer)
    1. BIM, BIPW Doppier, ar CW Doppler (Triplex) or CW Dopler (Triplex CW), BPower Doppler/W Doppler or CW Dopler, Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

11

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic evice Evaluation and Safety

510K

21

L9-4/38 Linear Transducers

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalmic
FetalPPPPPPPP [3-6,8]
AbdominalPPPPPPPP [3-6,8]
Intraoperative1
Intraoperative Neurological
PediatricPPPPPPPP [3-6,8]
Small Organ2PPPPPPPP [3-6,8]
Neonatal CephalicPPPPPPPP [3-6,8]
Adult CephalicPPPPPPPP [3-6,8]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral VascularPPPPPPPP [3-6,8]
Laparoscopic
MSK ConventionalPPPPPPPP [3-6,8]
MSK SuperficialPPPPPPPP [3-6,8]
Vascular AccessPPPPPPPP [3-6,8,10]
Nerve BlockPPPPPPPP [3-6,8,9]
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

  • Abdominal organs and vascular 1.
  • Breast, Thyroid, Testicle 2.
  • Elastography ന്
    1. Panoramic Imaging
    1. Compound Imaging .
    1. Freehand 3D Imaging
  • Live 3D/4D Imaging 7.
  • ல் Imaging for guidance of biopsy
  • ਹੋਂ lmaging for guidance of nerve block injections
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transducer)
    1. BM, BIPW Dopler or CW Doppler (Triplex) or CW Doppler (Triplex CW), BiPower Doppler/W Doppler, or CW Doppler, Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

(Division Sign-Off)

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e Evaluation and Safety

510k

22

L14-5/38 and L14-5/38 GPS Linear Transducers

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalmic
FetalPPPPPPP [3-6,8,11]
AbdominalPPPPPPP [3-6,8,11]
Intraoperative1
Intraoperative Neurological
PediatricPPPPPPP [3-5,8,11]
Small Organ2PPPPPPP [3-6,8,11]
Neonatal CephalicPPPPPPP [3-6,8,11]
Adult CephalicPPPPPPP [3-6,8,11]
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral VascularPPPPPPP [3-6,8,11]
Laparoscopic
MSK ConventionalPPPPPPP [3-6,8,11]
MSK SuperficialPPPPPPP [3-6,8,11]
Vascular AccessPPPPPPP [3-6,8,10,11]
Nerve BlockPPPPPPP [3-6,8,9,11]
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

  • Abdominal organs and vascular 1.
    1. Breast, Thyroid, Testicle
    1. Elastography
  • Panoramic Imaging ব
  • Compound Imaging 5.
  • ల్. Freehand 3D Imaging
    1. Live 3D/4D Imaging
  • Imaging for guidance of biopsy 8.
  • Imaging for guidance of nerve block injections 9.
    1. Imaging for guidance of central or peripheral lines
    1. Yolme Navigation/Inners''' (available only with the GPS transduce)
  1. BM, BPW Dopler, BC/PV Dopler BC/PW Dopler (Triplex CW), BPower Dopler/FW Dopler or CW D Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

.

_
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Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102997

23

L14-5W/60 Wide Linear Transducer

| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Power
Doppler | Combined
Modes | Other
[Notes] |
|-----------------------------|---|---|---------------|---------------|------------------|------------------|-------------------|------------------|
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P [3-6,8] |
| Abdominal | P | P | P | | P | P | P | P [3-6,8] |
| Intraoperative¹ | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P [3-6,8] |
| Small Organ² | P | P | P | | P | P | P | P [3-6,8] |
| Neonatal Cephalic | P | P | P | | P | P | P | P [3-6,8] |
| Adult Cephalic | P | P | P | | P | P | P | P [3-6,8] |
| Cardiac | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P [3-6,8] |
| Laparoscopic | | | | | | | | |
| MSK Conventional | P | P | P | | P | P | P | P [3-6,8] |
| MSK Superficial | P | P | P | | P | P | P | P [3-6,8] |
| Vascular Access | P | P | P | | P | P | P | P [3-6,8,10] |
| Nerve Block | P | P | P | | P | P | P | P [3-6,8,9] |
| Other | | | | | | | | |

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

    1. Abdominal organs and vascular
    1. Breast, Thyroid, Testicle
  • Elastography 3.
  • Panoramic Imaging 4.
    1. Compound Imaging
    1. Freehand 3D Imaging
    1. Live 3D/4D Imaging
  • Imaging for guidance of biopsy 8.
  • Imaging for guidance of nerve block injections 9.
    1. Imaging for guidance of central or peripheral lines
    1. Volume Navigation/Image Fusion/SonixGPS™ (available only with the GPS transducer)
    1. BAM, BPW Doppler or CV Dopler (Tiplex) or CW Dopler (Tiplex CW), BPower Dopler/W Dopler or CW Dopler or CW Dopler, or CW Dopler, or CW Dopler, or CW Doppler, or CW Dopple Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

Washing time 240

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102997

24

PA7-4/12 Phased Array Transducer

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes12Other
[Notes]
Ophthalmic
Fetal
AbdominalPPPPPPPP [3-6,8]
Intraoperative1
Intraoperative Neurological
PediatricPPPPPPPP [3-6,8]
Small Organ2
Neonatal CephalicPPPPPPPP [3-6,8]
Adult CephalicPPPPPPPP [3-6,8]
CardiacPPPPPPPP [3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
TranscranialPPPPPPPP [3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

    1. Abdominal organs and vascular
    1. Breast, Thyroid, Testicle
    1. Elastography
  • ধ Panoramic Imaging
  • റ Compound Imaging
    1. Freehand 3D Imaging
    1. Live 3D/4D Imaging
  • lmaging for guidance of biopsy 8.
  • lmaging for guidance of nerve block injections ഗ്
    1. Imaging for guidance of central or peripheral lines
  • Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

1 5

2

(Division Sign-Off) Division of Radiological Devices Office of Ir Vitro Diagnostic Device Evaluation and Safety

510K K102997

25

SA4-2/24 Phased Array Transducer

Clinical ApplicationMode of Operation
BMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes¹²Other
[Notes]
Ophthalmic
Fetal
AbdominalPPPPPPPP [3-6,8]
Intraoperative¹
Intraoperative Neurological
PediatricPPPPPPPP [3-6,8]
Small Organ²
Neonatal CephalicPPPPPPP [3-6,8]
Adult CephalicPPPPPPPP [3-6,8]
CardiacPPPPPPPP [3-6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
TranscranialPPPPPPPP [3-6,8]
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

    1. Abdominal organs and vascular
    1. Breast, Thyroid, Testicle
  • Elastography 3.
  • Panoramic Imaging ধ .
  • Compound Imaging ട.
  • ર. Freehand 3D Imaging
    1. Live 3D/4D Imaging
    1. Imaging for guidance of biopsy
  • Imaging for guidance of nerve block injections ਰੇ.
    1. Imaging for guidance of central or peripheral lines
  • 1 Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K102997

1 દ

26

mTEE8-3/5 Transesophageal Phased Array Radius Transducer

Mode of Operation
Clinical ApplicationBMPW
DopplerCW
DopplerColor
DopplerPower
DopplerCombined
Modes 12Other
[Notes]
Ophthalmic
Fetal
Abdominal
Intraoperative1
Intraoperative Neurological
Pediatric
Small Organ2
Neonatal Cephalic
Adult Cephalic
Cardiac
TransesophagealPPPPPPP
Transrectal
Transvaginal
Transurethral
Transcranial
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Vascular Access
Nerve Block
Other

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = New indication; P = Previously cleared under K093462

Notes:

  • Abdominal organs and vascular 1.
  • in Breast, Thyroid, Testicle
  • ਹੈ. Elastography
    1. Panoramic Imaging
  • ક. Compound Imaging
  • Freehand 3D Imaging 6.
    1. Live 3D/4D Imaging
    1. Imaging for guidance of biopsy
  • න් Imaging for guidance of nerve block injections
    1. Imaging for guidance of central or peripheral lines
  • 11 Standard on Station of Station in Area Maria (Times) of Stransfucer)
  1. Volume Play Dopler or CV Dopler (Tinlex) or CW Dopler (Triplex CW), BPower Dopler or CW Simultaneous Color Doppler or Power Doppler.

Prescription Use Only

ទាប់K

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Office of In Vitro Diagnostic Device Evaluation and Safety