LogoFDA 510(k) Search
K Number
K091009
Device Name
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
Manufacturer
ESAOTE S.P.A.
Date Cleared
2009-05-18

(39 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K072786,K061682,K051308,K052805,K060827
Predicate For
K103152,K110688,K111302,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 organ, 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 Musculoskeletal applications.

Esaote's Model 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 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 Musculoskeletal applications.

Device Description

The 7340 and 6150 system designs remain the same as those previously cleared by FDA via K081794, K051308, K052805, K060827, and K081386, respectively, except for those features being added via this submission.

The 6150 is a mainframe ultrasound system, and the 7340 is a portable ultrasound system, both are used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The systems are equipped with a LCD Color Display and are capable of operating Linear, Convex, and Phased array probes.

The 7340 and 6150 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

AI/ML Overview

The provided 510(k) summary for the Esaote 7340 & 6150 Systems is a premarket notification for new features added to previously cleared ultrasound imaging systems. It does not contain information about an in-depth study with acceptance criteria and device performance metrics in the way one might expect for a novel AI/ML device. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use.

Therefore, the requested information elements related to detailed study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for meeting acceptance criteria (as typically expressed for new performance claims) are not present in this type of submission. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to the identified predicate devices for the new features (Elastography and 3D/4D in specific applications).

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred, and noting where it is not applicable for this type of submission:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this 510(k) are demonstrating substantial equivalence. The device performance is implicitly considered equivalent to the predicate devices for the functionalities being added.

Acceptance Criteria (Implied for Substantial Equivalence)Reported Device Performance (Implied from Predicate Equivalence)
New Features (Elastography, 3D/4D): Performance in Elastography (ElaXto) and 3D/4D modality (Transvaginal, Transrectal, Urology) should be substantially equivalent to identified predicate devices.Elastography (ElaXto) Analysis: Substantially equivalent to Siemens eSie Elasticity Imaging module available with S2000 system (K072786). 3D/4D Modality (Transvaginal, Transrectal, Urology): Substantially equivalent to 3D/4D modality in the same applications available with RIC5-9-D probe of General Electric Voluson E8 system (K061682). These systems are able to provide elastographic analysis on real-time images by applying low compression/retraction movements using the probe. They are able to provide 3D/4D modality in Transvaginal, Transrectal and Urology applications by simultaneously controlling two independent scan planes for volumetric acquisition.
Safety Requirements: Meet IEC60601-1 and IEC60601-2-37 safety standards.The 7340, 6150, Siemens S2000, and General Electric Voluson E8 systems are designed to meet IEC60601-1 and IEC60601-2-37 safety requirements.
Acoustic Output Display: Provide an Acoustic Output Display feature per AIUM/NEMA standards, with equivalent Ispta and MI maximal values.The 7340, 6150, Siemens S2000, and General Electric Voluson E8 systems provide an Acoustic Output Display feature per AIUM/NEMA standards, with equivalent Ispta and MI maximal values.

Study Information (Based on the provided Summary)

This document is a 510(k) summary, not a full study report. It focuses on demonstrating equivalence rather than presenting a performance study with acceptance criteria.

  1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Not provided. This type of detail is not typically included in a 510(k) summary for a substantial equivalence claim based on predicate device features. It's implied that the predicate devices themselves underwent such testing. The current submission is more focused on the technical design equivalence of the new features.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Not provided. Ground truth establishment, if any for specific performance testing, would have been part of the predicate device clearances or internal testing not detailed in this summary.

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not provided. As a substantial equivalence claim, a formal adjudication process for a test set is not described.

  4. 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:

    • Not applicable. This document describes features of an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm or a comparative effectiveness study with human readers. The "AI" implied might be the "Elastography (ElaXto) analysis" and "3D/4D modality", but these are presented as imaging modes, not decision-support AI.

  5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    • Not applicable. This is an ultrasound imaging system rather than a standalone algorithm with a distinct performance evaluation. The added features are integral to the imaging process.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • Not provided. For a substantial equivalence claim regarding new imaging features like elastography and 3D/4D, technical specifications, image quality assessments, and possibly phantom studies are typically used to demonstrate equivalence rather than clinical ground truth from patient outcomes or pathology, unless explicit new clinical claims are being made.

  7. The sample size for the training set:

    • Not applicable / Not provided. These are ultrasound imaging systems with added features, not machine learning algorithms that typically require a distinct training set. The "training" in this context would likely refer to the general development and calibration process of imaging technologies, not a labeled dataset for AI.

  8. How the ground truth for the training set was established:

    • Not applicable / Not provided. As above, the concept of a "training set" and associated ground truth in the context of an AI/ML device is not directly relevant to this type of ultrasound system submission.

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

510(k) Summary
7340 & 6150 Systems
Esaote, S.p.A.

KC91009
Page 1 of 3

MAY 18 2009

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

Allison Scott The Anson Group 11460 N Meridian St., Ste 150 Carmel, Indiana 46032 Phone: (317) 569-9500 x106 Facsimile: (317) 569-9520 Ascott@ansongroup.com

Contact Person:Allison Scott
--------------------------------

Date: March 5, 2009

807.92(a)(2)

Trade Name: 7340 & 6150 Systems

Common Name: Ultrasound Imaging System

Ultrasonic pulse Doppler imaging system 892.1550 Classification Name(s): Ultrasonic pulsed echo imaging system 892.1560

Classification Number: 90IYN; 90IYO

807.92(a)(3)

Predicate Device(s)

K051308, K052805, K060827, and K081386 K081794 K072786 K061682

(150 7340 S2000 Voluson E8

Esaote, S.p.A. Siemens General Electric

Esaote, S.p.A.

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

KC91009
Page 2 of 3

510(k) Summary 7340 & 6150 Systems Esaote, S.p.A.

807.92 (a)(4)

Device Description

The 7340 and 6150 system designs remain the same as those previously cleared by FDA via K081794, K051308, K052805, K060827, and K081386, respectively, except for those features being added via this submission.

The 6150 is a mainframe ultrasound system, and the 7340 is a portable ultrasound system, both are used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The systems are equipped with a LCD Color Display and are capable of operating Linear, Convex, and Phased array probes.

The 7340 and 6150 systems are 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 organ, 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 Musculoskeletal applications.

Esaote's Model 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 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 Musculoskeletal applications.

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

K09mc9
Page 3 of 3

510(k) Summary 7340 & 6150 Systems Esaote, S.p.A.

807.92(a)(6)

Technological Characteristics

The 7340 model has been cleared via K081794; the 6150 has been cleared via K051308, K052805, K060827 and K081386.

The Elastography (ElaXto) analysis is substantially equivalent to Siemens eSie Elasticity Imaging module available with S2000 system cleared via K072786.

The 3D/4D modality in Transvaginal, Transrectal and Urology applications is substantially equivalent to 3D/4D modality in the same applications available with RIC5-9-D probe of General Electric Voluson E8 system cleared via K061682.

  • · Clinical uses for which the 7340 and 6150 are designed, to be added with this submission, are equivalent to those of the Siemens S2000 ultrasound system, cleared via K072786 and by the General Electric Voluson E8 cleared via K061682.
  • · The 7340, 6150 and Siemens S2000 ultrasound systems are able to provide Elastographic analysis on real-time images, by applying low compression and retraction movements on the patient using the probe to evaluate the modification of the echo signal.
  • · The 7340, 6150 and General Electric Voluson E8 systems are able to provide the 3D/4D modality in Transvaginal, Transrectal and Urology applications by simultaneously controlling two independent scan planes for volumetric acquisition.
  • · 7340, 6150, Siemens S2000 and General Electric Voluson E8 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
  • · 7340, 6150, Siemens S2000 and General Electric Voluson E8 provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.

{3}------------------------------------------------

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 a stylized symbol that resembles three overlapping lines or ribbons, creating a sense of movement or flow.

Public Health Service

MAY 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K091009

Trade/Device Name: 7340 Ultrasound Systems and 6150 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 4, 2009 Received: May 5, 2009

Dear Mr. Job:

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

This determination of substantial equivalence applies to the following transducers intended for use with the 7340 Ultrasound Systems and 6150 Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

Model 7340

PA230PA122LA424
PA240PA023LA435
PA121LA332LA522

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

Page 2 - Mr. Job

LA523LA532C5-2CA123CA421CA1421CA430CA431CA621CA6312 CW5 CWE8-5EC123EC1123TRT33TEE022TEE122IOE323LP323BC431BE1123
PA230PA240PA121PA122PA023LA332LA522LA523LA532LA424LA435LA923C5-2CA123CA421CA621CA430CA431CA6312CW5CWEC123EC1123TEE022TEE132IOE323LP323BC431BL433BE1123TRT33

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small

tone?

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

Page 2 — Mr. Job

Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.

Sincerely yours,

Helent Lenn
for Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health .

Enclosure(s)

、 :

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

Indications for Use Statement

Models 7340 and 6150

Indications for Use

510(k) Number (if known):

K091009

Device Name:

7340 Ultrasound Systems 6150 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, 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 Musculoskeletal applications.

Esaote's Model 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 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 Musculoskeletal applications.

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

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

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

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091009

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

Mod.7340

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
FetalPPPPPPPP: 5, 6, 7, 8, 9, 10
AbdominalPPPPPPPPEP: 4, 5, 6, 7, 8, 9, 13
Intraoperative (Abdominal)PPPPPPPPP: 4, 5, 6, 8, 9, 13
Intraoperative NeurologicalPPPPPPP
PediatricPPPPPPPPP: 4, 5, 6, 8, 9, 13
Small Organ [1]PPPPPPPEP: 4, 5, 6, 8, 9, 13;N: 14
Neonatal CephalicPPPPPPPPP: 5, 6, 8, 9
Adult CephalicPPPPPPPPP: 6, 8, 9
Cardiac [2]PPPPPPPPPEP: 4, 6, 7, 8, 9, 11,12
Transesophageal (Cardiac)PPPPPPPPPP: 4, 6, 9, 11, 12
Transesophageal (Non Cardiac)PPPPPPP
TransrectalPPPPPPPP: 4, 5, 6, 8, 9, 13;N: 14
TransvaginalPPPPPPPP: 5, 6, 8, 9
TransurethralPPPPPPP
IntravascularPPPPPPP
Peripheral VascularPPPPPPPPEP: 4, 5, 6, 7, 8, 9,10, 12, 13
LaparoscopicPPPPPPPP: 4, 5, 6, 8, 9, 13
Musculo-skeletal Conventional(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13;N: 14
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13;N: 14
Other (Urological)PPPPPPPP: 4, 5, 6, 8, 9, 13

[4]

(5) (છ)

[7]

(8)

lal

CMM

MView

3D

4D

VPan

XView

QIMT

.

(10)

[1] Stress [12] Strain

(13) TP View

[14] ElaXto

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiologicat Devices
510(k) Number K091009

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationMode of Operations
BMPWDCWDColor DopplerAmplitude DopplerCombined [3]TVMTissue Enhacement Imaging (TEI)CnTIOther (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPPEP: 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult CephalicPPPPPPPPP: 6, 8, 9
Cardiac [2]PPPPPPPPPEP: 4, 6, 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: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared: K081794 )

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

Cardiac is Adult and Pediatric

CMM

3D

  • (2) [3]
  • (4)
  • (6)
  • [8] VPan
  • XView (a)
  • (11) Stress
  • (12) Strain

Combined modes are: B + M + PW + CW + CFM + PD

CMM
3D
VPan
XView

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (specify)
Ophthalmic
Fetal
AbdominalEEEEEEEEP: 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult CephalicEEEEEEEEP: 8, 9
Cardiac [2]EEEEEEEEEP: 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: Previously 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
[8]VPan
[9]XView
[11]Stress
[12]Strain

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
Fetal
AbdominalEEEEEEEEP: 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]EEEEEEEEP: 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: Previously 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
[8]VPan
[9]XView
[11]Stress
[12]Strain

.k.leum

. .

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091009

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationMode of Operations
BMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (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: Previously cleared by FDA, E: Added under Appendix E
(Previously cleared: K081794)
[1] Small Organ includes Breast, Thyroid and Testicles

[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
[12]Strain

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091009

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEECnTIP: 8, 9
Small Organ [1]
Neonatal CephalicEEEEEEEP: 8, 9
Adult Cephalic
Cardiac [2]EEEEEEEP: 4, 8, 9, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 8, 9
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

N: New Indication, P: Previously 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
[8]VPan
[9]XView
[11]Stress
[12]Strain

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (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;N: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)PPPPPPPP: 4, 5, 6, 8, 9, 13;N: 14
Musculo-skeletal Superficial .(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13;N: 14
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: K081794 }

[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
[13]TP View
[14]ElaXto

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

510(k) NumberK091009
------------------------

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEP: 4, 5, 6, 8, 9, 12
Small Organ [1]EEEEEEP: 4, 5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEP: 4, 5, 6, 8, 9,12. 13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)EEEEEEP: 4, 5, 6, 8, 9, 12
Musculo-skeletal Superficial(including Nerve Blocking)EEEEEEP: 4, 5, 6, 8, 9, 12
Other (Urological)

N: New Indication, P: Previously 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 + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[12]Strain
[13]TP View

・

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 4, 5, 6, 8, 9, 13
Small Organ [1]EEEEEEEP: 4, 5, 6, 8, 9,13: N: 14
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 4, 5, 6, 8, 9,12. 13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)EEEEEEEP: 4, 5, 6, 8, 9,13; N: 14
Musculo-skeletal Superficial(including Nerve Blocking)EEEEEEEP: 4, 5, 6, 8, 9,13; N: 14
Other (Urological)

N: New Indication, P: Previously 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 + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[12]Strain
[13]TP View
[14]ElaXto

(Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 4, 5, 6, 8, 9, 12
Small Organ [1]EEEEEEEP: 4, 5, 6, 8, 9,13: N: 14
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 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: Previously 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 + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[10]QIMT
[12]Strain
[13]TP View
[14]ElaXto

(Division Sign-Off)
Division of Reproductive, Abdominal andRadiological Devices 510(k) Number

:

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (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;N: 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)PPPPPPPP: 4, 5, 6, 8, 9, 13;N: 14
Musculo-skeletal Superficial(including Nerve Blocking)PPPPPPPP: 4, 5, 6, 8, 9, 13;N: 14
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: K081794 )

[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]ElaXto

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices,
510(k) Number K091009

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 4, 5, 6, 8, 9, 1
Small Organ [1]EEEEEEEEP: 4, 5, 6, 8, 9, 1
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEEP: 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: Previously 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 + CFM + PD
[4]CMM
[5]MView
[6]3D
[8]VPan
[9]XView
[12]Strain
[13]TP View

Division of Reproductive, Abdominal and Radiological Devices 091009 510(k) Number

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

7340 - C5-2

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (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 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)

(Previously cleared: K081794 )

(10)

(12)

[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

(Division Sign-Off)QIMT

Strain

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 091009 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined [3]TVMTissue Enhacement Imaging (TEI)CnTIOther (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,
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)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: K081794 )

[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
(Division Sigh-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) NumberK091009

.

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (specify)
Ophthalmic
FetalEEEEEEEP: 5, 6, 8, 9
AbdominalEEEEEEEP: 5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 5, 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 5, 6, 8, 9
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)EEEEEEEP: 5, 6, 8, 9

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[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
[8]VPan
[9]XView

Hw lemen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices ત્વ 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9
AbdominalEEEEEEEP: 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 6, 8, 9
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)EEEEEEEP: 6, 8, 9

N: New Indication, P: Previously 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 + CFM + PD
[6]3D
[8]VPan
[9]XView

Hulb Reemen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9
AbdominalEEEEEEEEP: 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 VascularEEEEEEEP: 6, 8, 9
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)EEEEEEEP: 6, 8, 9

N: New Indication, P: Previously 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 + CFM + PD
[6]3D
[8]VPan
[9]XView

HutRemin

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9
AbdominalEEEEEEEP: 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 6, 8, 9
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)EEEEEEEP: 6, 8, 9
Musculo-skeletal Superficial(including Nerve Blocking)EEEEEEEP: 6, 8, 9
Other (Urological)EEEEEEEP: 6, 8, 9

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(1)Small Organs includes Breast, Thyroid and Testicles
(2)Cardiac is Adult and Pediatric
િર્ણાય વિદ્યારે તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમCombined modes are: B + M + PW + CFM + PD
ારા3D
181VPan
ત્વે)XView

Hertens

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

K091006

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTI Other (specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9
AbdominalPEEEEEEP: 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 6, 8, 9
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)EEEEEEEP: 6, 8, 9

N: New Indication, P: Previously 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 + CFM + PD
[6]3D
[8]VPan
[9]XView

Hukemen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (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: Previously cleared by FDA, E: Added under Appendix E d: K081794 ) ~12 (P

(Previously cleared: K081794)
[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

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091000

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

7340 - 2 CW

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWD CWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementlmaging (TEI)CnTIOther (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: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: K081794 )

  • (1)
  • (2) [3]

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

Combined modes are:

Hutten

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

7340 - 5 CW

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined [3]TVMTissue Enhacement Imaging (TEI)CnTIOther (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: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: K081794 )

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

Combined modes are:

Huplemen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

7340 - E8-5

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

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

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1]

[6]

(8)

Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

3D VPan

Combined modes are: B + M + PW + CFM + PD (3)

\

XView lal

Hulkeme

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

7340 - EC123

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

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

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1]

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

(2) (3) Combined modes are: B + M + PW + CFM + PD

(୧)

3D

  • (8) VPan XView ાં)
    Hw. Rem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

7340 - EC1123

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
FetalPPPPPPP5, 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; N: 14
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: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared: K081794 )

[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

XView QIMT

  • [14] ElaXto
    lal

[10]

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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

7340 - TRT33

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined [3]TVMTissue Enhacement Imaging (TEI)CnTIOther (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; N: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: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared: K081794 )

[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

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091009.

.

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

7340 - TEE022

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined [3]TVMTissue Enhacement Imaging (TEI)CnTIOther (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: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared: K081794 )

[1] Small Organs includes Breast, Thyroid and Testicles

Small Organs includes Breast, Cardiac is Adult and Pediatric

CMM

3D

  • (2) [3]

  • [4]

  • [୧]

[9] XView
[11] Strass

  • Stress (11)
  • [12] Strain

(Division Sign-Off)
Division of Reproductive, Abdominal and

Radiological Devices

Radiological Devices
510(k) Number

Combined modes are: B + M + PW + CW + CW + CFM + PD

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

7340 - TEE122

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (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: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: K081794 )

Small Organs includes Breast, Thyroid and Testicles [1]

[2] Cardiac is Adult and Pediatric

[3]

(a)

  • (4) CMM (6)
    3D
    XView

[11] Stress

  • Strain (12)
    Combined modes are: B + M + PW + CW + CFM + PD
    CMM
    3D
    XView

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

7340 - IOE323

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (specify)
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;N: 14
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: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: K081794 )

  • Small Organs includes Breast, Thyroid and Testicles (1) (2) Cardiac is Adult and Pediatric [3] Combined modes are: B + M + PW + CFM + PD [4] CMM [5] MView (୧) 3D ાજી VPan ાંત્રી XView (Division Sign-Off) (12) Strain Division of Reproductive, Abdominal and TP View (13) Radiological Devices [14] ElaXto 510(k) Number

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

7340 - LP323

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined [3]TVMTissue Enhacement Imaging (TEI)CnTIOther (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: Previously cleared by FDA, E: Added under Appendix E (Previously cleared: K081794 )

Small Organs includes Breast, Thyroid and Testicles
-----------------------------------------------------

(2) Cardiac is Adult and Pediatric

[3] Combined modes are: B + M + PW + CFM + PD

CMM

  • (বা)
  • (ટો MView
  • [e] 3D

[8] VPan

  • તિ) XView
  • [13] TP View

Her Penn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

7340 - BC431

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhancementImaging (TEI)CnTIOther (specify)
Ophthalmic
FetalPPP-PPPPP: 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: Previously cleared by FDA, E: Added under Appendix E eviously cleared: K081794 (P

(Previously cleared: K081794 )

[1]Sm
---------
[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
[12]Strain

(Division Sign-Off)

Division of Reproductive, Abdominal and

Radiological Devices

510(k) Number K091009

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

7340 - BE1123

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[3]TVMTissueEnhacementImaging (TEI)CnTIOther (specify)
Ophthalmic
FetalNNNNNNN5, 6, 7, 8, 9
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalNNNNNNN5, 6, 7, 8, 9
TransvaginalNNNNNNN5, 6, 7, 8, 9
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)NNNNNNN5,6,7,8,9

N: New Indication, P: Previously 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 + CFM + PD (ટ) MView (୧) 3D (7) 4D (8) VPan ત્વે XView

Hew Leum

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

6150

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (PD)Combined [4]Color Velocity Mapping (TVM)Tissue Enhacement Imaging (TEI)CnTIOther (specify)
Ophthalmic
FetalPPPPPPPPPPP: 5, 6, 7, 8, 9, 12, 13
AbdominalPPPPPPPPPPP: 5, 6, 7, 8, 9, 12, 13
Intraoperative (Abdominal)PPPPPPPPPPP: 6, 8, 9, 12, 13
Intraoperative Neurological
PediatricPPPPPPPPPPP: 5, 6, 7, 8, 9, 12, 13
Small Organ [1]PPPPPPPPPPP: 5, 6, 7, 8, 9, 12, 13; N:
Neonatal CephalicPPPPPPPPPPP: 5, 6, 8, 9, 12
Adult CephalicPPPPPPPPPPP: 5, 6, 7, 9, 12
Cardiac [2]PPPPPPPPPPP: 5, 6, 7, 8, 9, 10, 11, 12
Transesophageal (Cardiac)PPPPPPPPPPP: 5, 6, 9, 10, 11, 12
Transesophageal (Non Cardiac)
TransrectalPPPPPPPPPPP: 5, 6, 8, 9, 12, 13; N: 16
TransvaginalPPPPPPPPPPP: 5, 6, 8, 9, 12, 13
Transurethral
Intravascular
Peripheral VascularPPPPPPPPPPP: 5, 6, 7, 8, 9, 12, 13, 14
LaparoscopicPPPPPPPPPPP: 5, 6, 8, 9, 12, 13
Musculo-skeletal Conventional [3]PPPPPPPPPPP: 5, 6, 7, 8, 9, 12, 13; N:
Musculo-skeletal Superficial [3]PPPPPPPPPPP: 5, 6, 7, 8, 9, 12, 13; N:
Other (Urological)PPPPPPPPPPP: 5, 6, 7, 8, 9, 12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308, K052805, K060827, K081386)

[1] Small Organs includes

Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve

Block-

[4] Combined modes are:

B+M+PW+CW+CFM+PD

  • [5] CMM
  • [6] 3D
  • [7] 4D
  • [8] VPan
  • [9] XView
  • [10] Stress
  • [11] Xstrain

[12] Compound Imaging (MView)

  • [13] TP-View
  • [14] IMT
  • [15] QIMT
  • [16] ElaXto

Hublener

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDoppler(PD)Combined [4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalPPPPPPPPEP: 5, 6, 9
AbdominalPPPPPPPEPEP: 5, 6, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPEP: 5, 6, 9
Small Organ [1]PPPPPPPPEP: 5, 6, 9
Neonatal Cephalic
Adult CephalicPPPPPPPEPEP: 5, 6, 9
Cardiac [2]PPPPPPPEPEP: 5, 6, 9, 10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPEPEP: 5, 6, 9
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

  • {1} Small Organs includes Breast,
  • Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[4] Combined modes are:

B+M+PW+CW+CFM+PD

[5] CMM

[6] 3D

[9] XVicw

  • (10) Stress
  • (11) Xstrain

Hw leun

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDoppler(PD)Combined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEEP: 5, 6, 9
AbdominalEEEEEEEEP: 5, 6, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEEP: 5, 6, 9
Small Organ [1]EEEEEEEEP: 5, 6, 9
Neonatal Cephalic
Adult CephalicEEEEEEEEP: 5, 6, 9
Cardiac [2]EEEEEEEEEP: 5, 6, 9,10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEEP: 5, 6, 9
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast,

  • Thyroid and Testicles
  • [2] Cardiac is Adult and Pediatric
  • [4] Combined modes are:
  • B+M+PW+CW+CFM+PD
  • ાિક ભાગમાં
  • [6] 3D
  • [9] XView
  • [10] Stress
  • [11] Xstrain

Helene

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDoppler(PD)Combined[4]ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
Fetal
AbdominalPPPPPPPEPEP: 5, 6, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPEPEP: 5, 6, 9,10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

[2] Cardiac is Adult and Pediatric

[4] Combined modes are:

B+M+PW+CW+CFM+PD

  • [5] CMM
  • (6) 3D

[9] XView

  • (10) Stress [11] Xstrain
    V. L. Senn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{43}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
Fetal
AbdominalEEEEEEEEP: 5, 6, 9
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPEP: 5, 6, 9
Small Organ [1]
Neonatal CephalicPPPPPPPEP: 5, 6, 9
Adult Cephalic
Cardiac [2]PPPPPPPEEP: 5, 6, 9,10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPEP: 5, 6, 9
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E (Previously cleared K051308)

[2] Cardiac is Adult and Pediatric

[4] Combined modes are:

B+M+PW+CW+CFM+PD

[5] CMM

[6] 3D

[9] XView

  • [10] Stress
  • (1 l) Xstrain

Hefteim

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

{44}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPEP: 5, 6, 9
Small Organ [1]
Neonatal CephalicPPPPPPPEP: 5, 6, 9
Adult Cephalic
Cardiac [2]PPPPPPPEP: 5, 6, 9,10, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPEP: 5, 6, 9
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

[2] Cardiac is Adult and Pediatriatric

[4] Combined modes are:

B+M+PW+CW+CFM+PD

  • [5] CMM
    [6] 3D

[9] XView

[10] Stress

  • [11] Xstrain
    Hulbenn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

For Prescription Use Only

:

{45}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9,12, 13
AbdominalEEEEEEEP: 6, 8, 9,12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 6, 8, 9,12, 13
Small Organ [1]EEEEEEEP: 6, 8, 9,12, 13; N: 16
Neonatal CephalicEEEEEEEP: 6, 8, 9,12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 6, 8, 9,12, 13, 15
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEP: 6, 8, 9,12, 13; N: 16
Musculo-skeletal Superficial [3]EEEEEEEP: 6, 8, 9,12, 13; N: 16
Other (Urological)EEEEEEEP: 6, 8, 9,12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast,

  • Thyroid and Testicles
    [2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are:

  • B+M+PW+CFM+PD
  • [6] 3D
  • [8] VPan
  • [9] XView
  • [12] Compound Imaging (MView)
  • [13] TP-View
  • [15] QIMT
  • [16] ElaXto

Hutkeme

: ジ

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{46}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 6, 8,9,12,13
AbdominalEEEEEEEP: 6, 8,9,12,13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPEP: 6, 8,9,12,13
Small Organ [1]PPPPPPEP: 6, 8, 9,12, 13; N: 16
Neonatal CephalicEEEEEEEP: 6, 8, 9,12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPEP: 6, 8, 9, 12,13, 14, 15
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPEP: 6, 8, 9,12, 13; N: 16
Musculo-skeletal Superficial [3]PPPPPPEP: 6, 8, 9,12, 13; N: 16
Other (Urological)EEEEEEEP: 6, 8, 9,12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

[1] Small Organs includes Breast,

Thyroid and Testicles

[2] Cardiac is Adult and Pediatric [3] Musculo Skeletal - Nerve Block

[4] Combined modes are:

  • B+M+PW+CFM+PD
  • (6) 3D
  • [8] VPan
  • 19| XView

[12] Compound Imaging (MView)

  • [13] TP-View
  • (14) IMT
  • (15) QIMT
  • (16) ElaXto

Hulem

(Division Sign-Off) Division of Reproductive, Abdomina Radiological Devices 510(k) Number

{47}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9,12, 13
AbdominalEEEEEEEP: 6, 8, 9,12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPEPEP: 6, 8, 9,12, 13
Small Organ [1]PPPPPPEPEP: 6, 8, 9,12, 13; N:
Neonatal CephalicEEEEEEEP: 6, 8, 9,12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPEPEP: 6, 8, 9,12, 13, 14
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPEPEP: 6, 8, 9,12, 13; N:
Musculo-skeletal Superficial [3]PPPPPPEPEP: 6, 8, 9,12, 13; N:
Other (Urological)EEEEEEEP: 6, 8, 9,12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

ﻠﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

(Previously cleared K051308)

[1] Small Organs includes Breast,

Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

  • [4] Combined modes are:
  • B+M+PW+CFM+PD
  • [6] 3D
  • [8] VPan
  • [9] XView
  • [12] Compound Imaging (MView)
  • [13] TP-View
  • [14] IMT
  • (15) QIMT
  • [16] ElaXto

Luke Remie

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{48}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEEP: 6, 8, 9,12, 13
AbdominalEEEEEEEEP: 6, 8, 9,12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPEPEP: 6, 8, 9,12, 13
Small Organ [1]PPPPPPEPEP: 6, 8, 9,12, 13
Neonatal CephalicEEEEEEPEP: 6, 8, 9,12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPEPEP: 6, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEEP: 6, 8, 9,12, 13
Musculo-skeletal Superficial [3]EEEEEEEEP: 6, 8, 9,12, 13
Other (Urological)EEEEEEEEP: 6, 8, 9,12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308) [1] Small Organs includes Breast,

Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are:

B+M+PW+CFM+PD

[6] 3D

  • [8] VPan
  • {9| XView
  • [12] Compound Imaging (MView)

[13] TP-View

Herl Rem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{49}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined [4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPEP: 6, 8, 9,12, 13
Small Organ [1]PPPPPPEP: 6, 8, 9,12, 13
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPEP: 6, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPEP: 6, 8, 9,12, 13
Musculo-skeletal Superficial [3]PPPPPPEP: 6, 8, 9,12, 13
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

  • [1] Small Organs includes Breast,
    Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block

  • [4] Combined modes are:
  • B+M+PW+CFM+PD
  • [6] 3D
  • [8] VPan
  • [9] XView
  • [12] Compound Imaging (MView)

[13] TP-View

Hul Reum

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{50}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9,12, 13
AbdominalEEEEEEEP: 6, 8, 9,12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 6, 8, 9,12, 13
Small Organ [1]EEEEEEEP: 6, 8, 9,12, 13; N: 16
Neonatal CephalicEEEEEEEP: 6, 8, 9,12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 6, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEP: 6, 8, 9,12, 13; N: 16
Musculo-skeletal Superficial [3]EEEEEEEP: 6, 8, 9,12, 13; N: 16
Other (Urological)EEEEEEEP: 6, 8, 9,12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+PD

(6) 3D

  • [8] VPan
  • (9) XView
  • [12] Compound Imaging (MView)
  • (13] TP-View
  • [16] ElaXto

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{51}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerrAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEEP: 6, 8, 9,12, 13
AbdominalEEEEEEEEP: 6, 8, 9,12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEEP: 6, 8, 9,12, 13
Small Organ [1]EEEEEEEEP: 6, 8, 9,12, 13
Neonatal CephalicEEEEEEEEP: 6, 8, 9,12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEEP: 6, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEEP: 6, 8, 9,12, 13
Musculo-skeletal Superficial [3]EEEEEEEEP: 6, 8, 9,12, 13
Other (Urological)EEEEEEEEP: 6, 8, 9,12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are:

B+M+PW+CFM+PD

  • [6] 3D
  • [8] VPan
  • [9] XView
  • [12] Compound Imaging (MView)
  • [13] TP-View

Hulben

(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number

{52}------------------------------------------------

6150 - C5-2

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping (TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 5, 6, 8, 9,12
AbdominalEEEEEEEP: 5, 6, 8, 9,12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 5, 6, 8, 9,12
Small Organ [1]EEEEEEEP: 5, 6, 8, 9,12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]EEEEEEEP: 5, 6, 8, 9,10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 5, 6, 8, 9,12
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEP: 5, 6, 8, 9,12
Musculo-skeletal Superficial [3]EEEEEEEP: 5, 6, 8, 9,12
Other (Urological)EEEEEEEP: 5, 6, 8, 9,12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast,

Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

  • [4] Combined modes are:
  • B+M+PW+CFM+PD
  • (5) CMM
  • [6] 3D
  • [8] VPan
  • [9] XView
  • [10] Stress
  • [11] Xstrain
  • [12] Compound Imaging

Hu Rem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{53}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging(TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEPP: 5, 6, 8, 912
AbdominalPPPPPPEPEP: 5, 6, 8, 912
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPEPEP: 5, 6, 8, 912
Small Organ [1]PPPPPPEPEP: 5, 6, 8, 912
Neonatal CephalicPPPPPPEPEP: 5, 6, 8, 912
Adult CephalicP: 5, 6, 8, 912
Cardiac [2]PPPPPPEPEP: 5, 6, 8, 9,10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPEPEP: 5, 6, 8, 912
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEPP: 5, 6, 8, 912
Musculo-skeletal Superficial [3]EEEEEEPP: 5, 6, 8, 912
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E (Previously cleared K051308)

(11) Small Organs includes Breast

[1] Small Organs includes Breast, Thyroid and Testicles

  • [2] Cardiac is Adult and Pediatric
  • [3] Musculo Skeletal Nerve Block-

[4] Combined modes are:

  • B+M+PW+CFM+PD
  • (5) CMM
  • (6) 3D
  • [8] VPan
  • [9] XView
  • [10] Stress
  • [11] Xstrain
  • [12] Compound Imaging (MView)

Het Remer

Division Sign-Off) Division of Reproductive, Abdomin Radiological Device 510(k) Number

{54}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationMode of Operations
BMPWDCWDColor DopplerAmplitude DopplerCombined [4]Color Velocity Mapping (TVM)Tissue Enhacement Imaging (TEI)CnTIOther (specify)
Ophthalmic
FetalPPPPPPEPEP: 5, 6, 8, 9, 12
AbdominalPPPPPPEPEP: 5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPEPEP: 5, 6, 8, 9, 12
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPEPEP: 5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEEP: 5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]EEEEEEEEP: 5, 6, 8, 9, 12
Other (Urological)PPPPPPEPEP: 5, 6, 8, 9, 12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E (Previously cleared K051308)

[3] Musculo Skeletal - Nerve Block

  • [4] Combined modes are:
  • B+M+PW+CFM+PD
  • (5) CMM
  • [6] 3D
  • [8] VPan
  • [9] XView
  • [10] Stress
  • [11] Xstrain
  • [12] Compound Imaging (MView)

Hulbum

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{55}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined(4)ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalPPPPPPEPEP: 5, 6, 8, 9,12
AbdominalPPPPPPEPEP: 5, 6, 8, 9,12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEE
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPEPEP: 5, 6, 8, 9,12
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)PPPPPPEPEP: 5, 6, 8, 9,12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

[4] Combined modes are:

B+M+PW+CFM+PD

[5] CMM

  • (6) 3D
  • [8] VPan
  • {9] XView
  • [10] Stress
  • [11] Xstrain
  • [12] Compound Imaging (MView)

Hulkeem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

For Prescription Use Only

{56}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalPPPPPPPEP: 5, 6, 8, 9,12
AbdominalPPPPPPPEP: 5, 6, 8, 9,12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEEP: 5, 6, 8, 9,12
Small Organ [1]EEEEEEEEP: 5, 6, 8, 9,12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]EEEEEEEEP: 5, 6, 8, 9,10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPEP: 5, 6, 8, 9,12
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEEP: 5, 6, 8, 9,12
Musculo-skeletal Superficial [3]EEEEEEEEP: 5, 6, 8, 9,12
Other (Urological)EEEEEEEEP. 5, 6, 8, 9,12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

[1] Small Organs includes Breast,

Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are:

B+M+PW+CFM+PD

[5] CMM

[6] 3D

  • [8] VPan
  • [9] XView

[10] Stress

[11] Xstrain

[12] Compound Imaging (MView)

Hestleem

(Division Sigh-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K091009

{57}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEEP: 5, 6, 8, 9,12
AbdominalEEEEEEEEP: 5, 6, 8, 9,12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEEP: 5, 6, 8, 9,12
Small Organ [1]EEEEEEEEP: 5, 6, 8, 9,12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]EEEEEEEEP: 5, 6, 8, 9,10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEEP: 5, 6, 8, 9,12
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEEP: 5, 6, 8, 9,12
Musculo-skeletal Superficial [3]EEEEEEEEP: 5, 6, 8, 9,12
Other (Urological)EEEEEEEEP: 5, 6, 8, 9,12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast,

Thyroid and Testicles

  • [2] Cardiac is Adult and Pediatric
    [3] Musculo Skeletal - Nerve Block

  • [4] Combined modes are:

  • B+M+PW+CFM+PD

  • [5] CMM

  • (6) 3D

  • [8] VPan

  • [9] XView

  • [10] Stress

  • [11] Xstrain

  • [12] Compound Imaging (MView)

Hed Leun

Division Sign-Off) Division of Reproductive, Abdomina il and Radiological Devices 510(k) Number

{58}------------------------------------------------

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 5, 6, 8, 9,12
AbdominalEEEEEEEP: 5, 6, 8, 9,12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 5, 6, 8, 9,12
Small Organ [1]EEEEEEEP: 5, 6, 8, 9,12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]EEEEEEEP: 5, 6, 8, 9,10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 5, 6, 8, 9,12
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEP: 5, 6, 8, 9,12
Musculo-skeletal Superficial [3]EEEEEEEP: 5, 6, 8, 9,12
Other (Urological)EEEEEEEP: 5, 6, 8, 9,12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast,

Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

  • [3] Musculo Skeletal Nerve Block
  • [4] Combined modes are:
  • B+M+PW+CFM+PD
  • [5] CMM
  • (6) 3D
  • (8) VPan
  • [9] XView
  • [10] Stress
  • [11] Xstrain
  • [12] Compound Imaging (MView)

Hedleen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

For Prescription Use Only

. ੱਲ

{59}------------------------------------------------

6150 - 2CW

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerrAmplitudeDopplerCombined[4]ColorVelocityMappingTissueEnhancementImaging (TEI)CnTIOther(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 VascularP
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

[2] Cardiac is Adult and Pediatric

[4] Combined modes are: CW

Heleen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{60}------------------------------------------------

61500 - 5CW

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMappingTissueEnhacementImaging (TEI)CnTIOther(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 [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

[4] Combined modes are: CW

Hut Reem

(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{61}------------------------------------------------

6150 - EC123

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalPPPPPPEPEP: 5, 6, 8, 9,12
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPEPEP: 5, 6, 8, 9,12
TransvaginalPPPPPPEPEP: 5, 6, 8, 9,12
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)PPPPPPEPEP: 5, 6, 8, 9,12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E (Previously cleared K051308)

[4] Combined modes are:

B+M+PW+CFM+PD

[5] CMM

[6] 3D

[8] VPan

(9) XView

[12] Compound Imaging (MView)

Hed Reem

(Division Šign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{62}------------------------------------------------

6150 - EC1123

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping (TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 5, 6, 8, 9,12
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalEEEEEEEP: 5, 6, 8, 9,12; N: 16
TransvaginalEEEEEEEP: 5, 6, 8, 9,12
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)EEEEEEEP: 5, 6, 8, 9,12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[4] Combined modes are:

B+M+PW+CFM+PD

(5) CMM

[6] 3D

[8] VPan

{9} XView

[12] Compound Imaging (MView)

(16) ElaXto

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{63}------------------------------------------------

6150 - TEE022

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerrAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)PPPPPPPEPP: 5, 6, 9,10, 11
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional (3)
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K051308)

[4] Combined modes are:

B+M+PW+CW+CFM+PD

(5) CMM

[6] 3D

[9] XView

[10] Stress

[11] Xstrain

Heel Reeen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{64}------------------------------------------------

6150 - TEE132

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhancementImaging(TEI)CnTIOther(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)EEEEEEEEEP: 5, 6, 9,10, 11
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[4] Combined modes are:

B+M+PW+CW+CFM+PD

[5] CMM

[6] 3D

[9] XVicw

[10] Stress

[11] Xstrain

Hut Reem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{65}------------------------------------------------

6150 - IOE323

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMappingTissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9,12, 13
AbdominalEEEEEEEP: 6, 8, 9,12, 13
Intraoperative (Abdominal)PPPPPPPPP: 6, 8, 9,12, 13
Intraoperative Neurological
PediatricPPPPPPPPP: 6, 8, 9,12, 13
Small Organ [1]PPPPPPPPP: 6, 8, 9,12, 13; N: 16
Neonatal CephalicEEEEEEEP: 6, 8, 9,12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP: 6, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPPPP. 6, 8, 9,12, 13
Musculo-skeletal Superficial [3]PPPPPPPPP. 6, 8, 9,12, 13
Other (Urological)EEEEEEEP: 6, 8, 9,12. 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K052805)

[1] Small Organs includes Breast, Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block

  • [4] Combined modes are:
  • B+M+PW+CFM+PD
  • [6] 3D
  • [8] VPan
  • [9] XView
  • [12] Compound Imaging (MView)
  • [13] TP-View
  • [15] Automatic Gain
  • [17] FWI
  • [18] ElaXto

Hut Rem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{66}------------------------------------------------

6150 - LP323

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]Color VelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 6, 8, 9,12, 13
AbdominalEEEEEEEP: 6, 8, 9,12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 6, 8, 9,12, 13
Small Organ [1]EEEEEEEP: 6, 8, 9,12, 13
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 6, 8, 9,12, 13
LaparoscopicEEEEEEEP: 6, 8, 9,12, 13
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles [4] Combined modes are: B+M+PW+CFM+PD [6] 3D [8] VPan [9] XView [12] Compound Imaging (MView)

  • [13] TP-View
    Hrd Reum

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{67}------------------------------------------------

6150 - BC431

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMappingTissueEnhacementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalPPPPPPPPPP: 5, 6, 7, 8,9, 12
AbdominalPPPPPPPPPP: 5, 6, 7, 8,9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPPP: 5, 6, 7, 8,9, 12
Small Organ [1]EEEEEEEP: 5, 6, 7, 8,9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]EEEEEEEP: 5, 6, 7, 8,9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPPP: 5, 6, 7, 8,9, 12
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEP: 5, 6, 7, 8,9, 12
Musculo-skeletal Superficial [3]EEEEEEEP: 5, 6, 7, 8,9, 12
Other (Urological)PPPPPPPPPP: 5, 6, 7, 8,9, 12

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

(Previously cleared K060827)

[1] Small Organs includes Breast,

Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+PD

[5] CMM

િકી રૂD

[7] 4D

[8] VPan

  • [9] XView
  • [10] Stress

(11) Xstrain

[12] Compound Imaging (MView)

Het Leum

(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{68}------------------------------------------------

6150 - BL433

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalEEEEEEEP: 6, 7, 8, 9,12, 13
AbdominalEEEEEEEP: 6, 7, 8, 9,12, 13
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEP: 6, 7, 8, 9,12, 13
Small Organ [1]EEEEEEEP: 6, 7, 8, 9,12, 13
Neonatal CephalicEEEEEEEP: 6, 7, 8, 9,12, 13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEP: 6, 7, 8, 9,12, 13
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEP: 6, 7, 8, 9,12, 13
Musculo-skeletal Superficial [3]EEEEEEEP: 6, 7, 8, 9,12, 13
Other (Urological)EEEEEEEP: 6, 7, 8, 9,12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

  • [2] Cardiac is Adult and Pediatric
    [3] Musculo Skeletal - Nerve Block

  • [4] Combined modes are:

  • B+M+PW+CFM+PD

  • (6) 3D

  • [7] 4D

  • [8] VPan

  • [9] XView

  • [12] Compound Imaging (MView)

[13] TP-View

Here Rem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{69}------------------------------------------------

6150 - BE1123

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined [4]ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
FetalNNNNNNN5, 6, 8, 9,
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalNNNNNNN5, 6, 8, 9,
TransvaginalNNNNNNN5, 6, 8, 9,
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)NNNNNNN5, 6, 8, 9, 11

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[4] Combined modes are:

B+M+PW+CFM+PD

ાિક ભાગમાં આવેલા ગુજરાત રાજ્યના પાકની ખેત

[6] 3D

[8] VPan

[9] XView

[12] Compound Imaging (MView)

Hul Reem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{70}------------------------------------------------

6150 - TRT33

Intended use:

Diagnostic ultrasound imaging or fliud flow analysis of human body as follows:

Mode of Operations
Clinical ApplicationBMPWDCWDColorDopplerAmplitudeDopplerCombined[4]ColorVelocityMapping(TVM)TissueEnhancementImaging (TEI)CnTIOther(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalEEEEEEEP: 5, 6, 8, 9,12, 13; N: 16
TransvaginalEEEEEEEP: 5, 6, 8, 9,12, 13; N: 16
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)EEEEEEEP: 5, 6, 8, 9,12, 13

N: New Indication, P: Previously cleared by FDA, E: Added under Appendix E

[4] Combined modes are:

B+M+PW+CFM+PD

(5) CMM

[6] 3D

[8] VPan

[9] XView

[12] Compound Imaging (MView)

[13] TP-View

[16] ElaXto

Hed Reum

(Division Sidn-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

§ 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.