LogoFDA 510(k) Search
K Number
K151451
Device Name
Aplio 500/400/300 Diagnostic Ultrasound System V6.0
Manufacturer
TOSHIBA MEDICAL SYSTEMS CORPORATION
Date Cleared
2015-07-09

(41 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K141459,K072000,K131937,K142160
Predicate For
K161843,K163702
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Diaqnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small orqans, trans-vaqinal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophaqeal, musculo-skeletal (both conventional and superficial) and laparoscopic.

Device Description

The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the performance of the device's specific features. Instead, it describes performance testing conducted to demonstrate that the new and improved features performed as intended or equivalently to manual methods. The acceptance is based on demonstrating the functionality and clinical validity of the features.

Feature/TestAcceptance Criteria (Implicit)Reported Device Performance
Shear Wave Measurement (Elasticity Phantom)Accurate measurement of shear wave speed and elasticity of known targets within an elasticity phantom."The subject device accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom." (Page 47)
Smart 3D FeatureSuccessful display of 3D images using existing 2D transducers."The Smart 3D feature successfully displayed 3D images using existing 2D transducers." (Page 47)
Clinical Evaluation (Shear Wave)Acceptable images and numerical Shear wave results in vivo in volunteers."Representative clinical images of volunteers were obtained to confirm that the system provides acceptable images and numerical Shear wave results in vivo." (Pages 47-48)
Auto-NT FeatureEquivalent measurement of Nuchal Translucency thickness when compared to manual measurement."The tool is able to equivalently measure Nuchal Translucency thickness when compared to manual measurement." (Page 48)
General System PerformanceDevice performs as expected; is safe and effective for its intended use."Based upon bench testing, clinical evaluations, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use." (Page 48)

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

The document provides very limited detail on sample sizes and data provenance:

  • Shear Wave Measurement (Elasticity Phantom): Test set size is not specified, only "known targets within an elasticity phantom." Data provenance is not specified beyond "bench testing."
  • Smart 3D Feature: Test set size is not specified, performed using "existing 2D transducers." Data provenance is not specified.
  • Clinical Evaluation (Shear Wave): "Representative clinical images of volunteers" were used. The number of volunteers is not specified. Data provenance (e.g., country of origin, retrospective or prospective) is not specified.
  • Auto-NT Feature: The study "validated the performance of the Auto NT feature by demonstrating that the tool is able to equivalently measure Nuchal Translucency thickness when compared to manual measurement." The sample size for this study (number of cases or measurements) is not specified. Data provenance (e.g., retrospective or prospective) is not specified.

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

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical evaluations (e.g., for the Auto-NT feature or clinical Shear Wave results).

  • For the Shear Wave Measurement (Elasticity Phantom), the ground truth was "known targets within an elasticity phantom," implying a controlled, manufactured standard rather than expert interpretation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication methods (e.g., 2+1, 3+1, none) for any of the performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess how much human readers improve with AI vs. without AI assistance. The clinical evaluation for Auto-NT compares the tool's measurement to manual measurement, but it's not structured as an MRMC study to show reader improvement.

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

The document implies standalone performance testing for some features:

  • Shear Wave Measurement (Elasticity Phantom): This appears to be a standalone test of the algorithm's measurement accuracy against a known physical standard.
  • Smart 3D Feature: The testing confirmed the feature "successfully displayed 3D images using existing 2D transducers," suggesting standalone functional validation.
  • Auto-NT Feature: The validation compares the tool's measurement to manual measurement, which hints at standalone algorithm performance assessment.

The document does not explicitly use the term "standalone performance" but the descriptions of these tests align with the concept.

7. The Type of Ground Truth Used

  • Shear Wave Measurement (Elasticity Phantom): "known targets within an elasticity phantom" (physical phantoms with measurable properties).
  • Smart 3D Feature: Implicitly, the ground truth is the expected correct 3D image reconstruction from 2D data, likely evaluated visually for correct render and correspondence.
  • Clinical Evaluation (Shear Wave): For "numerical Shear wave results in vivo," the ground truth is clinical acceptability, presumably against a clinician's expectation or established medical practice, though not explicitly defined (e.g., pathology, outcomes, expert consensus).
  • Auto-NT Feature: "manual measurement" as the comparator for equivalence.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. Given that this is a 510(k) submission for an ultrasound system with updated features (rather than a de novo AI/ML medical device submission), details about training data for specific "tools" or "features" are not typically as extensively detailed unless they represent a novel AI component requiring such validation. The features mentioned, while advanced (e.g., Auto-NT, Smart 3D), might rely on established signal processing or image reconstruction algorithms rather than deep learning models requiring extensive training data.

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

Since no information about a training set is provided, there is also no information on how ground truth for any potential training set was established.

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Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 9, 2015

Toshiba Medical Systems Corporation % Mr. Orlando Tadeo Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K151451

Trade/Device Name: Aplio 500/400/300 Diagnostic Ultrasound System, V6.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 26, 2015 Received: May 29, 2015

Dear Mr. Tadeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K151451

Device Name

Aplio 500/400/300 Diagnostic Ultrasound System, V6.0

Indications for Use (Describe)

The Diaqnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small orqans, trans-vaqinal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophaqeal, musculo-skeletal (both conventional and superficial) and laparoscopic.

Type of Use (Select one or both, as applicable)

ك Prescription Use (Part 21 CFR 801 Subpart D)

  • Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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

1

System: Aplio 500, Aplio 400, Aplio 300 V6.0

Transducer:

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

Clinical Application Mode of Oneration

Clinical ApplicationSpecific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify) *THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
FetalPPPPP2PPPP5,7,8, 9,10,14,18,19
AbdominalPPPPP2,3PPPP5,7,8, 9,10,11,12,14,15,16,18,19
Intra-operative (Abdominal)PPPPP2PPP4,5,7,11,19
Intra-operative (Neuro)
LaparoscopicPPPPP2PPP5,7
PediatricPPPPP2,3PPPP5,7,8,9,10,12,14,15,18,19
Small Organ (Note 1)PPPPP2PPP4,5,6,7,8,9,10,11,14,15,16(N),17,18,19
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3PPP
Trans-rectalPPPPP2PPPP4,5,7,11,12,18
Trans-vaginalPPPPP2PPPP4,5,7,11,12,18
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPPP2PPP4,5,6,7,8,9,10,11,14,15,17,18,19
Musculo-skeletal (Superficial)PPPPP2PPP4,5,6,7,8,9,10,11,14,15,17,18,19
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPP4,13
Cardiac PediatricPPPPP3PPPP4,13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPP3P4,13
Intra-cardiac
Other (Specify)
Peripheral vesselPPPPP2PPP4,5,6,7,8,9,10,11,14,15,17,18,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K141459, K133761, K123992, K121422, K103629

Note 1 Small organ includes thyroid, breast and testicleNote 7 Precision ImagingNote 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWDNote 8 STICNote 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWDNote 9 3D Color (Volume Color)Note 15 SMI
Note 4 TDINote 10 STIC ColorNote 16 Shear wave
Note 5 ApliPureNote 11 ElastographyNote 17 BEAM
Note 6 MicroPureNote 12 FusionNote 18 Smart Navigation
Note 19 Smart 3D

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

System:

Transducer: PST-25BT

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP3PPP11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPP
Small Organ (Specify) (1)
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3PPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPP4,13
Cardiac PediatricPPPPP3PPPP4,13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 7 Precision Imaging Note 13 2D WMT Note 1 Small organ includes thyroid, breast and testicle Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; Note 8 STIC Note 14 Boost BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; Note 9 3D Color (Volume Color) Note 15 SMI BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 10 STIC Color Note 16 Shear wave Note 5 ApliPure Note 11 Elastography Note 17 BEAM Note 12 Fusion Note 18 Smart Navigation Note 6 MicroPure Note 19 Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)Mode of OperationBMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP3PPP11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPP
Small Organ (Specify) (1)
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3PPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPP4,13
Cardiac PediatricPPPPP3PPPP4,13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP3PPP11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPP
Small Organ (Specify) (1)
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3PPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPP4,13
Cardiac PediatricPPPPP3PPPP4,13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP3PPP11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPP
Small Organ (Specify) (1)
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3PPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPP4,13
Cardiac PediatricPPPPP3PPPP4,13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

System: _Aplio 500, Aplio 400, Aplio 300 V6.0

Transducer:___PVT-375BT

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

Clinical ApplicationMode of OperationOther [Note]
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4D
Ophthalmic
FetalPPPPP2PPP5,7,19
AbdominalPPPPP2PPP5,7,11,12,15,16,18,19
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP2PPP5, 7,12,15,18,19
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
-----------------------------------------------------------
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
--------------------------------------------------------------------------
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
-------------------------------------------------------------------------------------------
Note 4TDI
-------------
Note 5ApliPure
------------------
Note 6MicroPure
-------------------
Note 7Precision Imaging
---------------------------
Note 8STIC
--------------
Note 93D Color (Volume Color)
---------------------------------
Note 10STIC Color
---------------------
Note 11Elastography
-----------------------
Note 12Fusion
-----------------
Note 132D WMT
-----------------
Note 14Boost
----------------
Note 15SMI
--------------
Note 16Shear wave
---------------------
Note 17BEAM
---------------
Note 18Smart Navigation
---------------------------
Note 19Smart 3D
-------------------

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

System: _Aplio 500, Aplio 400, Aplio 300 V6.0

Transducer: _ PVT-375SC

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

Clinical ApplicationSpecific(Tracks 3)Mode of OperationOther [Note]
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPower2DCHI4D
Ophthalmic
FetalPPPP2PPP5,7,19
AbdominalPPPP2PPP5,7,11,12,15,16,18,19
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP5,7,12,15,18,19
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

System:

Transducer:

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

Clinical ApplicationSpecific(Tracks 3)Mode of OperationBMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther [Note]
Ophthalmic
FetalPPPP2PPPP5,7,8,9,10
AbdominalPPPP2PPPP5,7,8,9,10
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPP5,7,8,9,10
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1 Small organ includes thyroid, breast and testicleNote 7 Precision ImagingNote 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWDNote 8 STICNote 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWDNote 9 3D Color (Volume Color)Note 15 SMI
Note 4 TDINote 10 STIC ColorNote 16 Shear wave
Note 5 ApliPureNote 11 ElastographyNote 17 BEAM
Note 6 MicroPureNote 12 FusionNote 18 Smart Navigation
Note 19 Smart 3D

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

System: _Aplio 500, Aplio 400, Aplio 300 V6.0

Transducer:___PVT-382BT

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

Clinical ApplicationMode of OperationOther[Note]
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4D
Ophthalmic
FetalPPPP2PPP5, 7,18,19
AbdominalPPPP2PPP5, 7,12,18,19
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP5, 7,12,18,19
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1 Small organ includes thyroid, breast and testicleNote 7 Precision ImagingNote 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWDNote 8 STICNote 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWDNote 9 3D Color (Volume Color)Note 15 SMI
Note 4 TDINote 10 STIC ColorNote 16 Shear wave
Note 5 ApliPureNote 11 ElastographyNote 17 BEAM
Note 6 MicroPureNote 12 FusionNote 18 Smart Navigation
Note 19 Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
FetalPPPP2PPPP5,7,9
AbdominalPPPP2PPPP5,7,9
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPP5,7,9
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

System: Transducer:____PVT-661VT

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPP2PPP4,5,7,11
Trans-vaginalPPPPP2PPP4,5,7,11
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1 Small organ includes thyroid, breast and testicleNote 7 Precision ImagingNote 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWDNote 8 STICNote 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWDNote 9 3D Color (Volume Color)Note 15 SMI
Note 4 TDINote 10 STIC ColorNote 16 Shear wave
Note 5 ApliPureNote 11 ElastographyNote 17 BEAM
Note 6 MicroPureNote 12 FusionNote 18 Smart Navigation
Note 19 Smart 3D

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

System: Transducer:____PVT-781VT

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

Clinical ApplicationSpecific(Tracks 3)Mode of OperationBMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPP2PPP4,5,7,11,12,15,18
Trans-vaginalPPPPP2PPP4,5,7,11,12,15,18
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

System: Transducer: _ PVT-781VTE

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

Clinical ApplicationSpecific(Tracks 3)Mode of Operation
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNN2NNN4,5,7,11,12,15,18
Trans-vaginalNNNNN2NNN4,5,7,11,12,15,18
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: N/A

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
FetalPPPP2PPP5,7,14,15,19
AbdominalPPPP2PPP5,7,14,15,19
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP5,7,14,15,19
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
FetalPPPPP2PPPP5,7,8,9,10
AbdominalPPPPP2PPPP5,7,8,9,10
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP2PPPP5,7,8,9,10
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

System: Aplio 500, Aplio 400, Aplio 300 V6.0

Transducer: PVT-675MVL

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

Clinical ApplicationSpecific(Tracks 3)Mode of Operation
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther [Note]
Ophthalmic
FetalPPPPP2PPPP5,7,8,9,10
AbdominalPPPPP2PPPP5,7,8,9,10
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP2PPPP5,7,8,9,10
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1 Small organ includes thyroid, breast and testicleNote 7 Precision ImagingNote 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWDNote 8 STICNote 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWDNote 9 3D Color (Volume Color)Note 15 SMI
Note 4 TDINote 10 STIC ColorNote 16 Shear wave
Note 5 ApliPureNote 11 ElastographyNote 17 BEAM
Note 6 MicroPureNote 12 FusionNote 18 Smart Navigation
Note 19 Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)Mode of Operation
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPP2PPPPPP4,5,7,9,11
Trans-vaginalPPPPP2PPPPPP4,5,7,9,11
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

System: _Aplio 500, Aplio 400, Aplio 300 V6.0 Transducer: _ PVT-681MVL

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNN2NNNNN4,5,7,9,11,15
Trans-vaginalNNNNN2NNNNN4,5,7,9,11,15
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: N/A

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)Mode of OperationOther[Note]
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4D
Ophthalmic
Fetal
AbdominalPPPP2PPP5,7,19
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP5,7,19
Small Organ (Specify) (1)
Neonatal CephalicPPPP2PPP5,7,19
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
AbdominalPPPP2PPP5,7,19
Intra-operative (Abdominal)PPPP2PPP5,7,19
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)Mode of Operation
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
AbdominalPPPP2PPP5,7,19
Intra-operative (Abdominal)PPPP2PPP5,7,19
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)Mode of Operation
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
AbdominalPPPP2PPP5,7,19
Intra-operative (Abdominal)PPPP2PPP5,7,19
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPP2PPP4,5,7,11
Trans-vaginalPPPP2PPP4,5,7,11
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)Mode of Operation
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNN2NNN5,7,12,15,18
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: N/A

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PPP5,7,17,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPP5,7,17,19
Musculo-skeletal (Superficial)PPPP2PPP5,7,17,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,7,17,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation

Note 19 Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PPP5,7,17,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPP5,7,17,19
Musculo-skeletal (Superficial)PPPP2PPP5,7,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,7,17,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation

Note 19 Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)Mode of OperationCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PPP5,7,14,15,17,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPP5,7,14,15,17,19
Musculo-skeletal (Superficial)PPPP2PPP5,7,14,15,17,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,7,14,15,17,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation

Note 19 Smart 3D

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

System: Aplio 500, Aplio 400, Aplio 300 V6.0

Transducer: PLT-705BT

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

Clinical ApplicationSpecific(Tracks 3)Mode of Operation
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPPP2PPP5,7,15,17,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPPP2PPP5,7,15,17,19
Musculo-skeletal (Superficial)PPPPP2PPP5,7,15,17,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPPP2PPP5,7,15,17,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
AbdominalPPPP2PPP5,7,19
Intra-operative (Abdominal)PPPP2PPP5,7,19
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationSpecific(Tracks 3)Mode of OperationOther[Note]
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4D
Ophthalmic
Fetal
AbdominalPPPP2PPP5,7,19
Intra-operative (Abdominal)PPPP2PPP5,7,19
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PPP5,6,7,11,17,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPP5,6,7,11,17,19
Musculo-skeletal (Superficial)PPPP2PPP5,6,7,11,17,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,6,7,11,17,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation

Note 19 Smart 3D

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

1

System: _Aplio 500, Aplio 400, Aplio 300 V6.0

Transducer: _ PLT-1005BT

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

Clinical Application Mode of Operation

Clinical ApplicationSpecific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PPP5,6,7,11,12,14,15,16(N), 17,18,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPP5,6,7,11,12,14,15,17,18,19
Musculo-skeletal (Superficial)PPPP2PPP5,6,7,11,12,14,15,17,18,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,6,7,11,12,14,15,17,18,19
Other (Specify)

Onlet \ Specify )
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1 Small organ includes thyroid, breast and testicleNote 7 Precision ImagingNote 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWDNote 8 STICNote 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWDNote 9 3D Color (Volume Color)Note 15 SMI
Note 4 TDINote 10 STIC ColorNote 16 Shear wave
Note 5 ApliPureNote 11 ElastographyNote 17 BEAM
Note 6 MicroPureNote 12 FusionNote 18 Smart Navigation
Note 19 Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)PPPP2PP4,5,11,19
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PP4,5,11,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PP4,5,11,19
Musculo-skeletal (Superficial)PPPP2PP4,5,11,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PP4,5,11,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation

Note 19 Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PPP4,5,6,7,11,15,17,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPP4,5,6,7,11,15,17,19
Musculo-skeletal (Superficial)PPPP2PPP4,5,6,7,11,15,17,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP4,5,6,7,11,15,17,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

System: Transducer:

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PPP5,7,15,17,19
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPP5,7,15,17,19
Musculo-skeletal (Superficial)PPPP2PPP5,7,15,17,19
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,7,15,17,19
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation

Note 19 Smart 3D

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

System: _Aplio 500, Aplio 400, Aplio 300 V6.0 Transducer:___PLT-1204MV

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

Clinical ApplicationSpecific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PPPP5,7,8,9,10
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPPP5,7,8,9,10
Musculo-skeletal (Superficial)PPPP2PPPP5,7,8,9,10
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPPP5,7,8,9,10
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation

Note 19 Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPP3P4,13
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPP3P4,13
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPP3P4,13
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103629

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
LaparoscopicPPPP2PPP5,7
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselP
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicle
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4TDI
Note 5ApliPure
Note 6MicroPure
Note 7Precision Imaging
Note 8STIC
Note 93D Color (Volume Color)
Note 10STIC Color
Note 11Elastography
Note 12Fusion
Note 132D WMT
Note 14Boost
Note 15SMI
Note 16Shear wave
Note 17BEAM
Note 18Smart Navigation
Note 19Smart 3D

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System: Transducer:

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

Clinical ApplicationSpecific(Tracks 3)Mode of Operation[Note]
BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPower2DCHI2D4DOther
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselP
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459

Note 1Small organ includes thyroid, breast and testicleNote 7Precision ImagingNote 132D WMT
Note 2Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWDNote 8STICNote 14Boost
Note 3Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWDNote 93D Color (Volume Color)Note 15SMI
Note 4TDINote 10STIC ColorNote 16Shear wave
Note 5ApliPureNote 11ElastographyNote 17BEAM
Note 6MicroPureNote 12FusionNote 18Smart Navigation
Note 19Smart 3D

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Image /page/45/Picture/0 description: The image shows the logo for Toshiba. The word "TOSHIBA" is written in large, bold, red letters. Below the company name is the slogan "Leading Innovation" in black font, followed by three right-pointing arrows that fade from black to gray.

TOSHIBA AMERICA MEDICAL SYSTEMS, INC

2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) SUMMARY

SUBMITTER'S NAME: 1.

Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550

OFFICIAL CORRESPONDENT 2. Akinori Hatanaka

    1. ESTABLISHMENT REGISTRATION: 9614698

CONTACT PERSON: 4.

Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

Date Prepared: 5.

May 26, 2015 (Updated July 8, 2015)

6. TRADE NAME(S):

Diagnostic Ultrasound System Aplio 500 Model TUS-A500 V6.0 Aplio 400 Model TUS-A400 V6.0 Aplio 300 Model TUS-A300 V6.0

7. COMMON NAME:

System, Diagnostic Ultrasound

DEVICE CLASSIFICATION: 8.

Class II

Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [per 21 CFR 892.1570]

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9. PREDICATE DEVICE:

ProductMarketed by510(k) NumberClearance Date
Aplio 500/400/300 DiagnosticUltrasound System, V5.0Toshiba AmericaMedical SystemsK14145910/3/2014
Aplio XG Diagnostic UltrasoundSystem, Model SSA-790Aversion 2.0Toshiba AmericaMedical SystemsK07200007/30/2007
Voluson i/eGE HealthcareK13193709/24/2013
LOGIQ E9 DiagnosticUltrasound SystemGE HealthcareK14216010/10/2014

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculoskeletal (both conventional and superficial) and laparoscopic.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aplio 500/400/300 V5.0 Diagnostic Ultrasound System, 510(k) cleared under K141459, marketed by Toshiba America Medical Systems. The Aplio 500 Model TUS-A500 Version 6.0, Aplio 400 Model TUS-A400 Version 6.0 and Aplio 300 Model TUS-A300 Version 6.0 functions in a manner similar to and is intended for the same use as the predicate devices referenced within this submission. The subject device includes modifications to the cleared device which expands the Shear Wave indication and implements improvements to the Smart Navigation and SMI tools. Additionally, new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission are being added including Auto-NT, Smart 3D and three new transducers.

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DeviceAplio 500/400/300V5.0Aplio 500/400/300V6.0Comment
510(K) Control NumberK141459This Submission
Auto-NTNoYesNew Feature
Shear Wave (Small Organ)NoYesNew Indication
Smart 3DNoYesNew Feature
Shear WaveYesYesFeatureImprovement(s)
SMIYesYesFeatureImprovement(s)
Smart NavigationYesYesFeatureImprovement(s)
Smart FusionYesYesFeatureImprovement(s)
OBR (On Board Report)YesYesFeatureImprovement(s)
OB Work FlowYesYesFeatureImprovement(s)
Elastography KitAplio 500 andAplio 400 onlyAplio 500, Aplio400 and Aplio 300Implemented onAplio 300
PVT-781VTENoYesNew Transducer
PVT-681MVLNoYesNew Transducer
PVL-715RSTNoYesNew Transducer

14. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 (2005), IEC 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004 Output Display and ISO 10993-1 standards.

15. TESTING

Risk Analysis, Verification/Validation testing conducted through bench testing and clinical evaluation.

Performance Testing - Bench

Two studies were conducted to demonstrate that the new features and the improvements to existing features being implemented to the subject device performed as intended. One study demonstrated that the subject device accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom and another study confirmed that the Smart 3D feature successfully displayed 3D images using existing 2D transducers.

Performance Testing - Clinical

Two clinical evaluations were conducted to demonstrate that the subject device performed as expected. In one study, representative clinical images of volunteers were obtained to confirm that the system provides acceptable images and numerical Shear wave results in

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vivo. Another study validated the performance of the Auto NT feature by demonstrating that the tool is able to equivalently measure Nuchal Translucency thickness when compared to manual measurement.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.

16. CONCLUSION

The modifications incorporated into the Aplio 500 Model TUS-A500 Version 6.0, Aplio 400 Model TUS-A400 Version 6.0 and Aplio 300 Model TUS-A300 Version 6.0 do not change the intended use of the device. Based upon bench testing, clinical evaluations, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.

§ 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.