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K Number
K133761
Device Name
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
Manufacturer
TOSHIBA MEDICAL SYSTEMS CORPORATION
Date Cleared
2014-04-22

(132 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K121422,K103629,K123992
Predicate For
K141459,K161999
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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, and musculo-skeletal (both conventional and superficial).

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

This is a 510(k) premarket notification for modifications to an ultrasound system, not for an AI device. The document describes the device as the "Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300" diagnostic ultrasound systems. The submission is for "Modification of a cleared device" that "improves upon existing features including the image visualization of blood flow."

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device, along with details like "sample size used for the test set," "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set," is not applicable to this document.

The document does not describe an Artificial Intelligence (AI) / Machine Learning (ML) enabled device. It is a traditional medical device modification.

Here's what can be extracted regarding performance testing, although it's not in the context of AI acceptance criteria:

1. A table of acceptance criteria and the reported device performance:

This document does not provide specific quantitative acceptance criteria or detailed performance metrics in the format typically seen for AI device evaluations. The submission states:

  • Acceptance Criteria (Implicit): The device modifications meet the requirements for improved/added features. The device is safe and effective for its intended use.
  • Reported Device Performance: The modifications improve existing features, specifically "the image visualization of blood flow." The document also lists the various clinical applications and modes of operation for which the system and its transducers are indicated (e.g., Fetal, Abdominal, Cardiac, Peripheral Vascular, etc., and B-mode, M-mode, PWD, CWD, Color Doppler, etc.). However, it does not provide quantitative results like sensitivity, specificity, or image quality scores for these improvements or listed functionalities, as would be expected for an AI device.

2. Sample sized used for the test set and the data provenance:

  • Sample Size: Not specified for any test set.
  • Data Provenance: "acquisition of representative clinical images" was conducted as part of the testing. No country of origin is mentioned, and it is implied to be retrospective, as the images are "acquired."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable as this is not an AI device submission requiring expert human ground truth for algorithm performance evaluation. Testing involved "bench testing and the acquisition of representative clinical images."

4. Adjudication method for the test set:

  • Not applicable as this is not an AI device submission requiring adjudication of human expert annotations or ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • No MRMC comparative effectiveness study was done, as this is not an AI device.

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

  • Not applicable, as this is not an AI device.

7. The type of ground truth used:

  • For the "acquisition of representative clinical images", the ground truth is implicitly the clinical reality captured by the ultrasound imaging, verified by standard clinical interpretation and potentially other diagnostic methods. However, the document does not elaborate on how this "ground truth" was formally established or used to evaluate the new features of the device (like improved blood flow visualization) beyond stating that the features met requirements.

8. The sample size for the training set:

  • Not applicable, as this is not an AI device and thus has no training set in the AI/ML sense.

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

  • Not applicable, as this is not an AI device and thus has no training set.

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

K133761

TOSHIBA Leading Innovation 787

APR 2 2 2014

TOSHIBA AMERICA MEDICAL BYSTEMS, INC. 2441 Michelle Drive. Tustin. CA 92780

Phone: (714) 730-5000

510(k) SUMMARY

    1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
    1. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
    1. ESTABLISHMENT REGISTRATION: 2020563
  • CONTACT PERSON: 4. Mr. Charlemagne Chua Manager, Regulatory Affairs (714) 669-7896
  1. Date Prepared: December 6, 2013

TRADE NAME(S): 6.

.

Diagnostic Ultrasound System Aplio 500 Model TUS-A500 V4.0 Aplio 400 Model TUS-A400 V4.0 Aplio 300 Model TUS-A300 V4.0

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]

9. PREDICATE DEVICE:

ProductMarketed by510(k) NumberClearance Date
Aplio 500/400/300 DiagnosticUltrasound SystemToshiba AmericaMedical SystemsK123992February 6,2013

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

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, and musculo-skeletal (both conventional and superficial).

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aplio 500/400/300 V3.0 Diagnostic Ultrasound System, 510(k) cleared under K123992, marketed by Toshiba America Medical Systems. The Aplio 500 Model TUS-A500 Version 4.0, Aplio 400 Model TUS-A400 Version 4.0 and Aplio 300 Model TUS-A300 Version 4.0, functions in a manner similar to and is intended for the same use as the predicate device. The subject device includes modifications to the cleared device which improves upon existing features including the image visualization of blood flow. A comparison table is included in this submission detailing the similarities and differences between the predicate device and the subject device.

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, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, NEMA UD3 Output Display and ISO 10993-1 standards.

15. TESTING

Risk Analysis, Verification/Validation testing conducted through bench testing and the acquisition of representative clinical images included in this submission demonstrate that the requirements for the improved/added features have been met.

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

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

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 4.0, Aplio 400 Model TUS-A400 Version 4.0 and Aplio 300 Model TUS-A300 Version 4.0 do not change the indications for use or the intended use of the device. Based upon bench testing, acquisition of representative clinical images, 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.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized symbol that resembles a person embracing another person.

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

April 22, 2014

Toshiba Medical Systems Corporation Paul Biggins 2441 Michelle Drive TUSTIN CA 92780

Re: K133761

Trade/Device Name: Aplio 500/400/300 Diagnostic Ultrasound System V4.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 20, 2014 Received: March 21, 2014

Dear Mr. Biggins:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Aplio 55/400/300 Diagnostic Ultrasound System V4.0. as described in your premarket notification:

Transducer Model Number

PST-25BTPST-30BTPST-50BTPST-65AT
PVT-375BTPVT-375MVPVT-382BTPVT-382MV
PVT-661VTPVT-781VTPVT-674BTPVT-675MV
PVT-681MVPVT-712BTPVT-745BTFPVT-745BTH
PVT-745BTVPVT-770RTPLT-604ATPLT-704AT
PLT-704SBTPLT-705BTFPVT-705BTHPLT-805AT
PLT-1005BTPLT-1202SPLT-1204BTPLT-1204BX
PLT-1204MVPET-508MAPET-510MBPET-512MC
PC-20MPC-50M

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

Page 2-Mr. Biggins

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

FDA

for

Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K133761

Device Name

Aplio 500/400/300 V4.0 Diagnostic Ultrasound System

Indications for Use (Describe)

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, and musculo-skeletal (both conventional and superficial).

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

كا Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

System: _ Aplio 500, Aplio 400. Aplio 300 V4.0

Transducer:

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

ClinicalApplicationMode of Operation
Specific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther [Note]
Ophthalmic
FetalPPPPP2PPPP5,7,8,9,10,14
AbdominalPPPPP2,3PPPP5,7,8,9,10,11,12,14,15
Intra-operative(Abdominal)PPPPP2PPP4,5,7,11
Intra-operative(Neuro)
Laparoscopic
PediatricPPPPP2,3PPPP5,7,8,9,10,12,14,15
Small Organ (Note1)PPPPP2PPP4,5,6,7,8,9,10,11,14,15
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3PPP
Trans-rectalPPPPP2PPPP4,5,7,11,12
Trans-vaginalPPPPP2PPPP4,5,7,11,12
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal(Conventional)PPPPP2PPP4,5,6,7,8,9,10,11,14,15
Musculo-skeletal(Superficial)PPPPP2PPP4,5,6,7,8,9,10,11,14,15
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
Other (Specify)

N = new indication: P = previously cleared by FDA: E = added under this appendix Previous 510(k) of the transducers: K123992, K121422 and K103629

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes BIM: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI
    Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

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

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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI
    Note 5 ApliPure

  • Note 6 MicroPure
    Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer: PST-30BT

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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD: BDF/MDF/PWD; 2D/CWD; BDF/CWD

Notc 4 TDI

Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

System: Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer:_ PST-50BT

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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note 15 SMI

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

System: Transducer: PST-65AT

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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI

Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

Toshiba America Medical Systems, Inc.

System: __ Aplio_500, Aplio 400, Aplio 300 V4.0 Transducer:____ PVT-375BT

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
AbdominalPPPP2PPP5, 7,11,12,15
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP5, 7,12,15
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI

Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color) Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Notel 5 SMI

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

System: _ Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer:____PVT-375MV

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWD CWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note
Ophthalmic
FetalPPPP2PPbN15,7,8,9,10
Abdominalర్PPP2PPP .N5,7,8,9,10
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2P ·PPN5,7,8,9,10
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: K123992

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

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

System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer:___ PVT-382BT

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
AbdominalPPPP2PPP5, 7,12
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP5,7,12
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M: B/PWD: BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI
  • Note 5 ApliPure
  • Note 6 MicroPure
  • Note 7 Precision Imaging
  • Note 8 STIC

Note 9 3D Color (Volume Color)

  • Note 10 STIC Color
  • Note 11 Elastography
  • Note 12 Fusion
  • Note 13 2D WMT
  • Note 14 Boost

Note 15 SMI

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

System: Aplio 500. Aplio 400, Aplio 300 V4.0 Transducer: PVT-382MV

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
FetalPPPPP2PPPP5,7,9
AbdominalPPPPP2PPPP5,7,9
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP2PPPP5,7,9
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note 15 SMI

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

System: _ Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer: PVT-66IVT

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-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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI
  • Note 5 ApliPure
  • Note 6 MicroPure
  • Note 7 Precision Imaging
  • Note 8 STIC

Note 9 3D Color (Volume Color)

  • Note 10 STIC Color
  • Note 11 Elastography
  • Note 12 Fusion
  • Note 13 2D WMT
  • Note 14 Boost
  • Note 15 SMI

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

System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer: PVT-781VT

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

Clinical ApplicationSpecific(Tracks 3)Mode of OperationBMPWD CWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPP2PPP4,5,7,11,1
Trans-vaginalPPPP2PPP4,5,7,11,1
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI
  • Note 5 ApliPure .
  • Note 6 MicroPure
  • Note 7 Precision Imaging
  • Note 8 STIC
  • Note 9 3D Color (Volume Color)
  • Note 10 STIC Color
  • Note 11 Elastography
  • Note 12 Fusion

Note 13 2D WMT

  • Note 14 Boost
  • Note 15 SMI

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

Toshiba America Medical Systems, Inc.

510(k) Premarket Notification Aplio 500/400/300 V4.0Diagnostic Ultrasound System

System: _ Aplio 500. Aplio 400, Aplio 300 V4.0 Transducer:__ PVT-674BT

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
AbdominalPPPP2PPP5,7,14
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP5,7,14
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: K123992

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

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

System: __Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer: PVT-675MV

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

Clinical ApplicationSpecific(Tracks 3)BMPWDCWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOther[Note]
Ophthalmic
FetalPPPP2PPPP5,7,8,9,1
AbdominalPPPP2PPPP5,7,8,9,1
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPP5,7,8,9,1
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: K123992

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

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

System: Aplio 500. Aplio 400, Aplio 300 V4.0 Transducer: PVT-681MV

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-rectalPPPPP2PPPP4,5,7,9,1
Trans-vaginalPPPPP2PPPP4,5,7,9,1
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD

  • Note 3 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
    Note 4 TDI

Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

System: _ Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer:_ PVT-712BT

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
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP5,7
Small Organ (Specify) (1)
Neonatal CephalicPPPP2PPP5.7
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: K123992

Note 1 Small organ includes thyroid. breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD: BDF/PWD: BDF/MDF/PWD: 2D/CWD; BDF/CWD

.

Note 4 TDI

Note 5 ApliPure Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

System: __ Aplio 300, Aplio 400, Aplio 500 V4.0 Transducer: PVT-745BTF

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
AbdominalPPPPP2PPP5,7
Intra-operative (Abdominal)PPPPP2PPP5.7
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD

Note 3 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD: 2D/CWD; BDF/CWD

Note 4 TDI

Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

510(k) Premarket Notification Aplio 500/400/300 V4.0Diagnostic Ultrasound System

System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer:___PVT-745BTH

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
AbdominalPPPPP2PPP5,7
Intra-operative (Abdominal)PPPPP2PPP5,7
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: K123992

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

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

System: __ Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer:____PVT-745BTV

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWD CWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI204DOther[Notel
Ophthalmic.
Fetal
AbdominalPPPP2PPP5,7
Intra-operative (Abdominal)PPPP2PPP5,7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal1
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF/PWD: 2D/CWD: BDF/CWD

Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note 15 SMI

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

System: _ Aplio 500. Aplio 400, Aplio 300 V4.0 Transducer:___PVT-770RT

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-rectalPPPP2PPP4,5,7,1
Trans-vaginalPPPP2PPP4,5,7,1
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI Note 5 ApliPure . . . . Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT . Note 14 Boost Note 15 SMI

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

System: Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer:__ PLT-604AT

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
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)PPPP2PPP5,7
Musculo-skeletal (Superficial)PPPP2PPP5,7
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,7
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI

Note 5 ApliPure

Note 6 MicroPure Note 7 Precision Imaging

Note 8 STIC

Note 0.2D C.

Note 9 3D Color (Volume Color) Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

Toshiba America Medical Systems, Inc.

System: _ Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer:__PLT-704AT

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)PPPP2PPP5.7
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)PPPP2PPP5.7
Musculo-skeletal (Superficial)PPPP2PPP5.7
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5.7
Other (Specify)

N = new indication: P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K123992

Note 1 Small organ includes thyroid. breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD

  • Note 3 Combined mode includes BM: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
    Note 4 TDI

Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

Note 8 STIC

Note 9 3D Color (Volume Color)

Note 10 STIC Color

Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

System: _Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer:___PLT-704SBT

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)PPPP2PPP5,7,14.1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)PPPP2PPP5,7,14.1
Musculo-skeletal (Superficial)PPPP2PPP5,7,14.1
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,7.14.1
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF/PWD: 2D/CWD; BDF/CWD

Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note15 SMI

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

System: __ Aplio 500. Aplio 400. Aplio 300 V4.0 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
AbdominalPPPP2PPP5,7
Intra-operative (Abdominal)PPPP2PPP5,7
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
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD: BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note 15 SMI

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

System: Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer: PVT-705BTH

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
AbdominalPPPP2PPP5,7
Intra-operative (Abdominal)PPPP2PPP5,7
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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI
    Note 5 ApliPure

Note 6 MicroPure Note 7 Precision Imaging

Note 8 STIC

Note 0 STR
Note 0 DEX

Note 9 3D Color (Volume Color)

Note 10 STIC Color Note 11 Elastography

Note 12 Fusion

Note 13 2D WMT

Note 14 Boost

Note 15 SMI

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

Toshiba America Medical Systems, Inc.

System: _ Aplio 500. Aplio 400, Aplio 300 V4.0 Transducer:_ PLT-805AT

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
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPP5,6,7,11
Musculo-skeletal (Superficial)PPPP2PPP5,6,7,11
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,6,7,11
Other (Specify)

N = new indication: P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD; BDF/MDF: BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI

  • Note 5 ApliPure
    Note 6 MicroPure

Note 7 Precision Imaging

  • Note 8 STIC
    Note 9 3D Color (Volume Color)

Note 10 STIC Color

  • Note 11 Elastography
  • Note 12 Fusion

Note 13 2D WMT

  • Note 14 Boost
    Note 15 SMI

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

System: Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer:_ PLT-1005BT

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)PPPP2PPP5,6,7,11,14,15
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)PPPP2PPP5,6,7,11,14,15
Musculo-skeletal(Superficial)PPPP2PPP5,6,7,11,14,15
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP5,6,7,11,14,15
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K123992

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD · Note 3 Combined mode includes B/M: B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note 15 SMI Prescription Use Only (Per 21 CFR 801.109)

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

System: Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer: PLT-1202S

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
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPP2PP4, 5, 11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PP4, 5, 11
Musculo-skeletal (Superficial)PPPP2PP4, 5, 11
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PP4, 5, 11
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K123992

Note I Small organ includes thyroid. breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD

Note 3 Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF: BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 TDI
  • Note 5 ApliPure

Note 6 MicroPure

Note 7 Precision Imaging

  • Note 8 STIC
    .

Note 9 3D Color (Volume Color)

  • Note 10 STIC Color
    Note 11 Elastography

  • Note 12 Fusion
    Note 13 2D WMT

  • Note 14 Boost
    Note 15 SMI

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

System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer:____PLT-1204BT

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)PPPPP2PPP4,5,6,7,11,15,
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)PPPPP2PPP4,5,6,7,11,15
Musculo-skeletal (Superficial)PPPPP2PPP4,5,6,7,11,15
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPPP2PPP4,5,6,7,11,15
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K123992

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

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

Toshiba America Medical Systems, Inc.

System: _ Aplio 500 300 V4.0 . Transducer:___________________________________________________________________________________________________________________________________________________________________ PLT-1204BX

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)PPPPP2PPP5,7
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)PPPPP2PPP5,7
Musculo-skeletal (Superficial)PPPPP2PPP5,7
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPPP2PPP5,7
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K123992

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

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

Toshiba America Medical Systems, Inc.

System: _Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer:___PLT-1204MV

Transducer. RL1-1204MV

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)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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

.

Note 4 TDI -Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost

Note 15 SMI

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

System: _ Aplio 500. Aplio 400. Aplio 300 V4.0

Transducer: PET-508MA

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: K123992

Note 1 Small organ includes thyroid. breast and testicle. Note 2 Combincd mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD: 2D/CWD; BDF/CWD Note 4 TDI . . Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note 15 SMI

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

System: _Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer: PET-510MB

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: K123992

Note 1 Small organ includes thyroid. breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF: BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI ・・・ -------------... ・・ ' ! - -・ Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note 15 SMI

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

510(k) Premarket Notification Aplio 500/400/300 V4.0Diagnostic Ultrasound System

System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer:___________________________________________________________________________________________________________________________________________________________________ PET-512MC

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: 103629

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

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

Toshiba America Medical Systems, Inc.

System: _ Aplio 500. Aplio 400, Aplio 300 V4.0 Transducer: PC-20M

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

Clinical ApplicationMode of Operation
Specific(Tracks 3)BMPWD CWDColorDopplerCombined(Specify)*THIDynamicFlowPowerCHI2D4DOtherNotel
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: K123992

Note 1 Small organ includes thyroid. breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost Note 15 SMI

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

System: ______________________________________________________________________________________________________________________________________________________________________ Transducer:___ PC-50M

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: K123992

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD; BDF/MDF: BDF/MDF/PWD

  • Note 3 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF/PWD; 2D/CWD; BDF/CWD
    Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost

Note 15 SMI

§ 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.