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K Number
K110688
Device Name
MYLABGOLD
Manufacturer
ESAOTE
Date Cleared
2011-06-02

(83 days)

Product Code
IYO,ITX,IYN
Regulation Number
892.1560
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
k032875,k033311,k003739,k040719,K081794,K091009
Predicate For
K121384,K132231,K140677
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-skeletal applications. The 7340 system provides imaging for venous system measurements.

Device Description

Model 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and onscreen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer. Model 7340 can be equipped with an internal battery that provides power when no main power is available.

The 7340 system has been cleared by FDA via K081794 and K091009.

Model 7340 upgrade, defined herein, combines the features of the Model 7340 with other, previously cleared software features and new software capabilities to assist a physician in making venous measurements. The venous imaging software package includes:

    1. Dedicated Presets for Venous System Imaging, CFM and Doppler
    1. QDP Quality Doppler Profiles Technology based on Multigate Doppler algorithm
    1. Optimized Probe management for Venous Intracranial Doppler

The 7340 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

AI/ML Overview

The provided text is a 510(k) summary for the Esaote Model 7340 ultrasound system upgrade (K110688). This document primarily focuses on establishing substantial equivalence to predicate devices and detailing the intended uses and technological characteristics. It does NOT contain information about specific performance acceptance criteria or detailed study results for the device's clinical performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract information related to general non-clinical testing and the type of ground truth implied by regulatory standards.

Here's a breakdown of what can be inferred or explicitly stated from the document regarding the study and acceptance criteria proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

  • None explicitly stated for clinical performance. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards for safety and performance, rather than reporting on specific clinical performance metrics with acceptance criteria benchmarks.

2. Sample Size Used for the Test Set and Data Provenance:

  • Not specified. The document does not describe any specific clinical test or validation set with patient data. The non-clinical testing mentioned refers to engineering verification and validation against technical standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

  • Not applicable for clinical ground truth. Since no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

  • Not applicable. No clinical test set or adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

  • No MRMC study mentioned. This document predates widespread AI integration in medical devices and does not describe any such study. The device is an "Ultrasound Imaging System" with software features to assist in "venous measurements" and "venous system imaging."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

  • Not applicable. The device is an ultrasound system with software features, not a standalone AI algorithm. It's an imaging device for physician use.

7. The Type of Ground Truth Used:

  • Implied ground truth through adherence to recognized standards and substantial equivalence. The primary "proof" that the device performs as intended relies on:
    • Substantial Equivalence: The device's "technological characteristics" (including clinical uses, flow profile capabilities, and safety standards) are deemed "equivalent" to those of previously cleared predicate devices (Esaote 7340, Aloka SD5500, Aloka 4000). The implication is that if the predicate devices were safe and effective, and this device is equivalent, then it is also safe and effective.
    • Non-Clinical Testing against Recognized Standards: Verification and validation tests were conducted "in accordance with design controls per CFR 820.30" and designed to meet specific international and national standards. These standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2) effectively serve as the "ground truth" for the device's technical and safety performance. This includes electrical safety, electromagnetic compatibility, essential performance, and acoustic output measurements.

8. The Sample Size for the Training Set:

  • Not applicable. The document does not describe a machine learning algorithm with a training set. The "upgrade" consists of dedicated presets, a specific Doppler technology, and optimized probe management, which are software features, not a trainable AI model.

9. How the Ground Truth for the Training Set Was Established:

  • Not applicable. As no training set for a machine learning model is mentioned, there's no information on how its ground truth would have been established.

Summary of what the document does provide:

  • Device Name: Model 7340 upgrade
  • Intended Use: Diagnostic general ultrasound studies across various applications (Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative, Laparoscopic, Urologic). Includes imaging for guidance of biopsy, needle placement, peripheral nerve blocks, and venous system measurements.
  • Predicate Devices: Esaote 7340 (K081794, K091009), Aloka SD5500 (K032875, K033311), Aloka 4000 (K003739, K040719).
  • New Features in Upgrade: Dedicated Presets for Venous System Imaging (CFM and Doppler), QDP Quality Doppler Profiles Technology (based on Multigate Doppler algorithm), Optimized Probe management for Venous Intracranial Doppler.
  • Safety and Performance Validation: Non-clinical testing conducted per CFR 820.30 and adherence to recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2.
  • Quality System: Manufactured under ISO 9001:2000 and ISO 13485 certified quality system.

The document demonstrates the device's "substantial equivalence" to previously cleared devices and its compliance with established safety and performance standards for diagnostic ultrasound systems. It does not provide data from clinical trials or specific performance metrics with acceptance criteria as one might expect for a novel AI-driven diagnostic device today.

{0}------------------------------------------------

510(k) Summary Model 7340 Upgrade Esaote, S.p.A.

K110688
Page 1 of 3

JUN - 2 2011

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).

807.92(a)(1)

Submitter Information

Esaote S.p.,A Via di caciolle 15 50127 Firenze Italy

Contact Person:Allison Scott317.569.9500 x106ascott@ansongroup.com
Date:February 7, 2011
807.92(a)(2)
Trade Name:Model 7340 upgrade
Common Name:Ultrasound Imaging System
Classification Name(s):Ultrasonic pulse Doppler imaging system 892.1550Ultrasonic pulsed echo imaging system 892.1560Diagnostic ultrasonic transducer 892.1570
Classification Number:90IYN, 90IYO, 90ITX
807.92(a)(3)
Predicate Device(s)
K081794 and K0910097340 Esaote, S.p.A.
K032875 and K033311SD5500 Aloka

K003739 and K040719

4000

Aloka

{1}------------------------------------------------

K1/0688
Page 2 of 3

510(k) Summary Model 7340 Upgrade Esaote, S.p.A.

807.92 (a)(4)

Device Description

Model 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and onscreen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer. Model 7340 can be equipped with an internal battery that provides power when no main power is available.

The 7340 system has been cleared by FDA via K081794 and K091009.

Model 7340 upgrade, defined herein, combines the features of the Model 7340 with other, previously cleared software features and new software capabilities to assist a physician in making venous measurements. The venous imaging software package includes:

    1. Dedicated Presets for Venous System Imaging, CFM and Doppler
    1. QDP Quality Doppler Profiles Technology based on Multigate Doppler algorithm
    1. Optimized Probe management for Venous Intracranial Doppler

The 7340 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use(s)

Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-skeletal applications. The 7340 system provides imaging for venous system measurements.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text includes the identifier "K110688" on the first line, followed by "Page 3 of 3" on the second line. The handwriting appears to be cursive and slightly slanted.

510(k) Summary Model 7340 Upgrade Esaote, S.p.A.

807.92(a)(6)

Technological Characteristics

The 7340 model has been cleared via K081794 and K091009. The Aloka SD5500 system has been cleared via K032875 and K033311; the Aloka 4000 has been cleared via K003739 and K040719.

  • · Clinical uses for which the 7340 is designed are not changed by the 7340 upgrade, to be cleared via this submission.
  • · Clinical uses for which the Esaote 7340 and 7340 upgrade systems are designed are equivalent to those of the Aloka SD5500 ultrasound system, cleared via K032875 and K033311 and of the Aloks 4000 cleared via k K003739 and K040719.
  • · Esaote 7340 and 7340 upgrade, the Aloka SD5500 and Aloka 4000 ultrasound systems are able to provide the profile of the flow of the vessels under exam. The Aloka SDS500 system has been cleared via K032875 and K033311; the Aloka 4000 has been cleared via K003739 and K040719.
  • · Esaote 7340 and 7340 upgrade, Aloka SD5500 and Aloka 4000 ultrasound systems are designed to meet the IEC60601-1 and IEC60601-2-37.safety requirements.
  • · Esaote 7340 and 7340 upgrade, Aloka SD5500 and Aloka 4000 ultrasound systems provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values. ******************************************************************************************************************************************************************************

807.92(b)(1)

Non-Clinical Testing

Verification and validation tests have been conducted in accordance with design controls per CFR 820.30.

The system has been designed to meet the following standards:

  • IEC 60601-1 .
  • IEC 60601-1-2 ●
  • IEC 60601-2-37 .
  • ISO 10993-1 .
  • AIUM/NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • AIUM/NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic � Ultrasound

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

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

Esaote, S.p.A. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

JUN - 2 2011

Re: K110688

Trade/Device Name: 7340 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 17, 2011 Received: May 18, 2011

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the 7340 Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

PA230LA523CA621TRT33
PA240LA532CA631TEE022
PA121C5-2 R132 CWTEE122
PA122CA1235CWTEE132
PA023CA421HF CWIOE323
LA332CA1421E8-5 R10PLP323
LA424CA430EC123BS230
LA435CA431EC1123BC431
LA522CA531BE1123BL433

{4}------------------------------------------------

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 (OS) 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.html 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 Joshua Nipper at (301) 796-6524.

Sincerely Yours,

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

{5}------------------------------------------------

Indications for Use Statement

Model 7340

Indications for Use

510(k) Number (if known):

Device Name:

7340 Ultrasound Systems

Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculo-Skeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-Skeletal applications. The 7340 system provides imaging for venous system flow profile.

Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patil

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110688

{6}------------------------------------------------

Mod.7340 upgrade

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPPP: 4, 5, 6, 7, 8, 9, 10, 13
AbdominalPPPPPPPPP: 4, 5, 6, 7, 8, 9, 13
Intraoperative (Abdominal)PPPPPPPPP: 4, 5, 6, 8, 9, 13
Intraoperative Neurological
PediatricPPPPPPPPP: 4, 5, 6, 7, 8, 9, 13
Small Organ [1]PPPPPPPPP: 4, 5, 6, 7, 8, 9, 13, 14
Neonatal CephalicPPPPPPPPP: 5, 6, 8, 9
Adult CephalicPPPPPPPPP: 6, 8, 9; N: 15
Cardiac [2]PPPPPPPPP[16]P: 4, 5, 6, 7, 8, 9, 11, 12
Transesophageal (Cardiac)PPPPPPPPPP: 4, 6, 9, 11, 12
Transesophageal (Non Cardiac)
TransrectalPPPPPPPPP: 4, 5, 6, 7, 8, 9, 13, 14
TransvaginalPPPPPPPPP: 5, 6, 7, 8, 9, 14
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP: 4, 5, 6, 7, 8, 9, 10, 12, 13; N: 15
LaparoscopicPPPPPPPPP: 4, 5, 6, 8, 9, 13
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPPP: 4, 5, 6, 7, 8, 9, 13, 14
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPPP: 4, 5, 6, 7, 8, 9, 13, 14
Other (Urological)PPPPPPPPP: 4, 5, 6, 7, 8, 9, 13

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[5]MView
[6]3D
[7]4D
[8]VPan
[9]XView
[10]QIMT
[11]Stress
[12]Strain
[13]TP View
[14]ElaXto
[15]Quality Doppler Profile (QDP)

Mary Slostel

(Division Sign-Off)

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

510K K110688

[16] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K081794 and
K091009

{7}------------------------------------------------

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPPP: 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult CephalicPPPPPPPPP: 6. 8, 9
Cardiac [2]PPPPPPPPP[16]P: 4, 6, 8, 9, 11,12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional (includingNerve Blocking)
Musculo-skeletal Superficial (includingNerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles(DivisionDivision of RadOffice of In Vitro Diagnostic510K
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[6]3D
[8]VPan
[9]XView
[11]Stress
[12]Strain

Mary Scott

Sign-Off) ological Devices Device Evaluation and Safety

K110688
510K

[16] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

{8}------------------------------------------------

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPPP: 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult CephalicPPPPPPPPP: 8, 9; N: 15
Cardiac [2]PPPPPPPPP[16]P: 4, 8, 9, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial (includingNerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[8]VPan
[9]XView
[11]Stress
[12]Strain
[15]Quality Doppler Profile (QDP)
[16]Includes contrast (CnTi) in Adult Cardiac for left ventricle opacification and visualization

of the left ventricular endocardial border

Mary Sfotel

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

510K K110688

{9}------------------------------------------------

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPPP: 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPPP: 4, 8, 9, 11,12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[8]VPan
[9]XView
[11]Stress
[12]Strain

Mary S/otd

Division of Radiological Devices Office of In Vitro Diag Evaluation and Safety

510K K110688

{10}------------------------------------------------

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPP: 6, 8, 9
Small Organ [1]
Neonatal CephalicPPPPPPPPP: 6, 8, 9
Adult Cephalic
Cardiac [2]PPPPPPPPPP: 4, 6, 8, 9, 11,12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP: 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[6]3D
[8]VPan
[9]XView
[11]Stress

Strain

(12)

May S. Patel
(Division Sign-Off)

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

510K 110688

{11}------------------------------------------------

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 8, 9
Small Organ [1]
Neonatal CephalicPPPPPPPP: 8, 9
Adult Cephalic
Cardiac (2)PPPPPPPP: 4, 8, 9, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 8, 9
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[8]VPan
[9]XView
[11]Stress
[12]Strain

Division of Radiological Devices Office of In Vitro Diagnos aluation and Safety

510K K110C688

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

:

{12}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 4, 5, 6, 8, 9, 13
Small Organ [1]PPPPPPPP: 4, 5, 6, 8, 9, 13, 14
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 4, 5, 6, 8, 9, 10, 12, 13; N: 15
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[12]StrainOffice of
[13]TP View
[14]ElaXto510K
[15]Quality Doppler Profile (QDP)

Mary Stotl
(Division Sign-Off)

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

510K. K110688

{13}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP: 4, 5, 6, 8, 9,13
Small Organ [1]PPPPPPP: 4, 5, 6, 8, 9,13
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP: 4, 5, 6, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPP: 4, 5, 6, 8, 9,13
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPP: 4, 5, 6, 8, 9,13
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Strain

TP View

Previously cleared via K091009

(1)

(2)

[3]

(4)

ાંટો

រេរវា

। 1 ओ

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD CMM

MVicw

  • ાંઠા 3D (8] VPan ત્વે XVicw
    Mary S. Potter
    (Division Sign-Off)

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

510K K110688

{14}------------------------------------------------

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

Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP: 4, 5, 6, 8, 9, 13
Small Organ [1]PPPPPPP: 4, 5, 6, 8, 9,13, 14
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP: 4, 5, 6, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPP: 4, 5, 6, 8, 9,13, 14
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPP: 4, 5, 6, 8, 9,13, 14
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

(1) Small Organs includes Breast, Thyroid and Testicles [2] Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CW + CFM + PD (4) CMM (5) MView ાંઠા 3D [8] VPan (ગુ XView [12] Strain [13] TP Vicw (14) ElaXto

Masa S/oth
(Division Sign-Off)

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

510K K110688

{15}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 4, 5, 6, 8, 9,13
Small Organ [1]PPPPPPPP: 4, 5, 6, 8, 9,13, 14
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 4, 5, 6, 8, 9,10, 12, 13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organ
[2]Cardiac is A
[3]Combined m
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[12]Strain
[13]TP View
[14]FlexXto

gans includes Breast, Thyroid and Testicles
is Adult and Pediatric
ed modes are: B + M + PW + CW + CFM + PD

May S. Patel
Division Sign-On

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

510K K110688

{16}------------------------------------------------

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

Clinical ApplicationMode of OperationsOther (specify)
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMappingTissueEnhancementImaging (TEI)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 4, 5, 6, 8, 9, 13
Small Organ [1]PPPPPPPP: 4, 5, 6, 8, 9, 13,14
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 4, 5, 6, 8, 9, 10,12, 13, N:15
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13,14
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13,14
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[13]TP View
[14]ElaXtoOffice of
[15]Quality Doppler Prodile (QDP)

Mury S. Patel
(Division Sign-Off)

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

510K K110688

{17}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined(3)TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 4, 5, 6, 8, 9, 11
Small Organ [1]PPPPPPPP: 4, 5, 6, 8, 9, 11
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular.
Peripheral VascularPPPPPPPP: 4, 5, 6, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

(1)

(기

(3)

(4)

(S)

(છ)

(12)

| | 3|

Small Organs includes Breast, Thyroid and Testicles . Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD смм

MView 3D

VPan

XView

Strain

TP Vicw

(8) lal

Mary Stott
(Division Sign-Off)

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

510K K110688

{18}------------------------------------------------

7340 - C5-2 R13

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

Clinical ApplicationMode of OperationsOther (specify)
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)
Ophthalmic
FetalPPPPPPPP: 5, 6, 8, 9, 10
AbdominalPPPPPPPP: 5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5, 6, 8, 9
Small Organ [1]
Neonatal CephalicPPPPPPPP: 5, 6, 8, 9
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

510K

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[5]MView
[6]3D
[8]VPan
[9]XView
[12]Strain
Mary S Patel(Division Sign-Off)Division of Radiological DevicesOffice of In Vitro Diagnostic Device Evaluation and Safety

Prescription Use Only Per 21 CFR 801 Part D
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

{19}------------------------------------------------

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5, 6, 8, 9
Small Organ [1]PPPPPPPP: 4, 5, 6, 8, 9
Neonatal CephalicPPPPPPPP: 5, 6, 8, 9
Adult Cephalic
Cardiac [2]PPPPPPPP: 4, 5, 6, 8, 9, 11,12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5, 6, 8, 9, 12; N:15
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[11]Stress
[12]Strain
[15]Quality Doppler Profile (QDP)

Mary S. Pott
(Division Sign-Off)

of Radiological Devices gnostic Device Evaluation and Safety

510K. K110688

{20}------------------------------------------------

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 8, 9, 10
AbdominalPPPPPPPP: 5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5, 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPP: 5, 6, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[12]Strain

Mary S Pastel
(Division Sign-Off)

ogical Devices vice Evaluation and Safety

510K K110688

{21}------------------------------------------------

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 8, 9, 10
AbdominalPPPPPPPP: 5,6,8,9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5, 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPP: 5, 6, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[12]Strain
(Division Sign-Off)Division of Radiological Devices

Mary S. Pottl
(Division Sign-Off)

Office of In Vitro Diagnostic Device Evaluation and Safety

K110688
510K

.

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

:

{22}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 8, 9, 10
AbdominalPPPPPPPP: 5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP: 5, 6, 8, 9
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPPP: 5, 6, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1] Small Organs includes Breast, Thyroid and Testicles (2) Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CFM + PD (5) MView (e) 3D (8) VPan lal XView (10) QIMT (12) Strain ision Sinn. Divis of Radiological Devices Office of In Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K110688

{23}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 8, 9, 10
AbdominalPPPPPPPP: 5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5, 6, 8, 9
Small Organ (1)
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPP: 5, 6, 8, 9
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 5, 6, 8, 9
Other (Urological)PPPPPPPP: 5, 6, 8, 9

N: New indication: P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[12]Strain(Division Sign-OfDivision of RadiologicalOffice of In Vitro Diagnostic Device

Mary S Pett
(Division Sign-Off)

Devices valuation and Safety

510K K110688

{24}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5.6, 8, 9, 10
AbdominalPPPPPPPP: 5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP5, 6. 8, 9
Small Organ [1]PPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5,6,8,9,12
Laparoscopic
Musculo-skeletal Conventional (includingNerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9
Musculo-skeletal Superficial (includingNerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9
Other (Urological)PPPPPPPP: 5, 6, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

시 Small Organs includes Breast, Thyroid and Testicles 12| Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CFM + PD ત્ત્વન смм (5) MView (છ) 3D C [8] VPan (9) XVicw (Division Sign-Off) QIMT (10) Division of Radiological Devices [12] Strain Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110688

{25}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 8, 9, 10
AbdominalPPPPPPPP: 5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5, 6, 8, 9, 10
Small Organ [1]P: 5, 6, 8, 9
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5, 6, 8, 9, 10
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPP: 5, 6, 8, 9

Previously cleared via K091009

| |

(2)

(3)

(5)

ાંઠા

ાકો

lal

(10)

112]

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CFM + PD MView

3D

V Pan

XVicw

QIMT

Strain

Mary S. Patel
(Division Sign-Off)

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

510K K110688

{26}------------------------------------------------

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

Clinical ApplicationMode of Operations
BMPWDCWDColor· DopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 8, 9, 10
AbdominalPPPPPPPP: 5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5, 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9
Other (Urological)PPPPPPPP: 5, 6, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[12]Strain

{27}------------------------------------------------

7340 - 2 CW

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined [3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E Previously cleared via K091009

| 1 | (기

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric

Mary Spotel.
(Division Sign-Off)

Office of In valuation and Safety

510K K110688

{28}------------------------------------------------

7340 - 5 CW

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularP
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E Previously cleared via K091009

[1] (2) Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric

Mina S. Patel
(Division Sign-Off)

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

510K K110688

{29}------------------------------------------------

7340 - HF CW

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularP
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K103152

(1) [2]

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric

Muss S. Pidd

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

510K K110688

{30}------------------------------------------------

7340 - E8-5 R10P

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPPP: 5, 6, 8, 9
TransvaginalPPPPPPPPP: 5, 6, 8, 9
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPPP: 5, 6, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

(1)Small Organs includes Breast, Thyroid and Testicles
(2)Cardiac is Adult and Pediatric
(3)Combined modes are: B + M + PW + CFM + PD
િટોMView
(e)3D
(8)VPan------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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  • (8) lal
    Mary Stodd

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

510K K110688

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

{31}------------------------------------------------

7340 - EC123

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP: 5, 6, 8, 9
TransvaginalPPPPPPPP: 5, 6, 8, 9
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPP: 5, 6, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

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Small Organs includes Breast, Thyroid and Testicles
Cardiac is Adult and Pediatric
Combined modes are: B + M + PW + CFM + PD
MView

3D

VPan

XView

Mary S. Patel
(Division Sign-Off)

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

510K K110688

{32}------------------------------------------------

7340 - EC1123

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 8, 9, 10
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP: 5, 6, 8, 9
TransvaginalPPPPPPPP: 5, 6, 8, 9
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPP: 5, 6, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E Previously cleared via K091009

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[14]ElaXto

May S. Patel
(Division Sign-Off)

adiological Devices Office of In Diagnostic Device Evaluation and Safety

510K K110688

{33}------------------------------------------------

7340 - BE1123

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 7, 8, 9
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP: 5, 6, 7, 8, 9
TransvaginalPPPPPPPP: 5, 6, 7, 8, 9
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPP: 5, 6, 7, 8, 9

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[5]MView
[6]3D
[7]4D
[8]VPan
[9]XView

Mary States
(Division Sign-Off)

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

510K K110688

{34}------------------------------------------------

7340 - TRT33

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)Tissue EnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP: 4, 5, 6, 8, 9, 13,14
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)PPPPPPPP: 4, 5, 6, 8, 9, 13

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[13]TP View
[14]ElaXto
Mary S Pastel (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K K110688

Prescription Use Only Per 21 CFR 801 Part D
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

{35}------------------------------------------------

7340 - TEE022

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominai
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)PPPPPPPPPP: 4, 6, 9, 11, 12
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[6]3D
[9]XView
[11]Stress
[12]Strain

Mury Stace
(Division Sign-Off)

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

510K. K110688

{36}------------------------------------------------

7340 - TEE122

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)PPPPPPPPPP: 4, 6, 9, 11, 12
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[6]3D
[9]XView
[11]Stress
[12]Strain

Mury Stahl
(Division Sign-Off)

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

510K K110688

{37}------------------------------------------------

7340 - TEE132

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)PPPPPPPPPP: 4, 6, 9, 11, 12
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[9]XView
[11]Stress
[12]Strain

Mary S. Patel

(Division Sign-Off)

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

510K 110688

{38}------------------------------------------------

7340 - IOE323

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)
Ophthalmic
Fetal
AbdominalPPPPPPPP: 4, 5, 6, 8, 9, 13
Intraoperative (Abdominal)PPPPPPPP: 4, 5, 6, 8, 9, 13
Intraoperative Neurological
PediatricPPPPPPPP: 4, 5, 6, 8, 9, 13
Small Organ [1]PPPPPPPP: 4, 5, 6, 8, 9, 13
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 4, 5, 6, 8, 9, 12,13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[12]Strain
[13]TP View

Mary Slatel
(Division Sign-Off)

Radiological Devices tic Device Evaluation and Safety

510K K110688

,

{39}------------------------------------------------

7340 - LP323

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

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPP: 4, 5, 6, 8, 9, 13
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
LaparoscopicPPPPPPPP: 4, 5, 6, 8, 9, 13
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[13]TP View

Device Evaluation and Safety
510K K110688

  • Prescription Use Only Per 21 CFR 801 Part D
    Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

{40}------------------------------------------------

7340 - BS230

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhacementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPPPP: 4, 6, 7, 8, 9, 11,12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicles
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CW + CFM + PD
[4]CMM
[6]3D
[7]4D
[8]VPan
[9]XView
[11]Stress
[12]Strain

Mary Slatl
(Division Sign-Off)

insion of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110688

{41}------------------------------------------------

7340 - BC431

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 7, 8, 9,10
AbdominalPPPPPPPP: 5, 6, 7, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5, 6, 7, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via K091009

[1]Small Organs includes Breast, Thyroid and Testicle
[2]Cardiac is Adult and Pediatric
[3]Combined modes are: B + M + PW + CFM + PD
[5]MView
[6]3D
[7]4D
[8]VPan
[9]XView
[12]Strain

Mary Postle
(Division Sign-Off)

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

510K R110688

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

{42}------------------------------------------------

7340 - BL433

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

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TissueVelocityMapping(TVM)TissueEnhancementImaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 4, 5, 6, 7, 8, 9,13
Small Organ [1]PPPPPPPP: 4, 5, 6, 7, 8, 9,13
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 4, 5, 6, 7, 8, 9,13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 7, 8, 9,13
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 7, 8, 9,13
Other (Urological)

Previously cleared via K091009

(1) Small Organs includes Breast, Thyroid and Testicles (2) Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CFM + PD (4) СММ ાંડા MView ાંઠા 3D (7) 4D (8) VPan ત્ત્વે XView (13) TP View

Mary S Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Satet;

510K. K110688

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.