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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
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
More Information

K123992

K121422, K103629

No
The summary does not mention AI, ML, or any related terms, and the device description is typical of a standard ultrasound system.

No
The device is described as a "Diagnostic Ultrasound System" indicated for "visualization of structures... to provide image information for diagnosis," not for treatment.

Yes
The "Intended Use / Indications for Use" section explicitly states that the system provides "image information for diagnosis," and the "Device Description" section refers to it as "diagnostic ultrasound systems."

No

The device description explicitly states it is a "mobile diagnostic ultrasound system" and mentions employing "a wide array of probes," which are hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
  • Device Description: The provided description clearly states that the Aplio 500/400/300 systems are "diagnostic ultrasound systems" that visualize "structures, and dynamic processes with the human body using ultrasound." This means they are used externally on the patient to create images, not to analyze samples taken from the patient.
  • Intended Use: The intended use describes visualizing structures and processes within the human body for diagnosis. This aligns with the function of an ultrasound machine, not an IVD.

Therefore, based on the provided information, this device is a diagnostic imaging system, not an In Vitro Diagnostic.

N/A

Intended Use / 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).

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial)

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

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

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123992

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K121422, K103629

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

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 Diagnostic
Ultrasound SystemToshiba America
Medical 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:

| Clinical

ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,8,9,10,14 |
    | Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,8,9,10,11,12,14,15 |
    | Intra-operative
    (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 |
    | Intra-operative
    (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,8,9,10,12,14,15 |
    | Small Organ (Note
  1.        | P                 | P | P   | P   | P                | 2                          | P   | P               | P     |           |    | 4,5,6,7,8,9,10,11,14,15 |

| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7,11,12 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7,11,12 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph.
(non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,15 |
| Musculo-skeletal
(Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,15 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Intravascular
(Cardiac) | | | | | | | | | | | | |
| Trans-esoph.
(Cardiac) | P | P | P | P | P | 3 | P | | | | | 4,13 |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,15 |
| 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)BMPWDCWDColor
DopplerCombined
(Specify)THIDynamic
FlowPowerCHI
2D4DOther
[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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
    | Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4.13 |
    | Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
    | Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
    | Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
    | 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 Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    |------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | P | P | P | P | P | 3 | P | P | P | | | 11 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | P | P | P | P | P | 3 | P | P | P | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | | |
    | Neonatal Cephalic | | P | P | P | P | P | 3 | P | P | P | | | |
    | Adult Cephalic | | P | P | P | P | P | 3 | P | P | P | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
    | Cardiac Pediatric | | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | | P | 2 | P | P | P | | | 5, 7 |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 5, 7,11,12
    ,15 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | P | P | | | 5, 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 CWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | | P | 2 | P | P | b | | N | 15,7,8,9,10 |
    | Abdominal | ర్ | P | P | | P | 2 | P | P | P . | | N | 5,7,8,9,10 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P · | P | P | | N | 5,7,8,9,10 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | | P | 2 | P | P | P | | | 5, 7 |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 5, 7,12 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,7,12 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,9 |
    | Abdominal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,9 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | P | P | 2 | P | P | P | | P | 5,7,9 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | P | P | P | | P | 2 | P | P | P | | | 4,5,7,11 |
    | Trans-vaginal | P | P | P | | P | 2 | P | P | P | | | 4,5,7,11 |
    | 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 Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD CWD | Color
Doppler | Combined
(Specify)

  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    |------------------------------------------------|-------------------|---|---|---------|------------------|----------------------------|-----|-----------------|-------|-----------|------------|-----------------|
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | P | P | P | P | 2 | P | P | P | | | 4,5,7,11,1 | |
    | Trans-vaginal | P | P | P | P | 2 | P | P | P | | | 4,5,7,11,1 | |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | | P | 2 | P | P | P | | | 5,7,14 |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,14 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,7,14 |
    | 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 Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    |------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,1 |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,1 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,1 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | | |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7,9,1 | |
    | Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7,9,1 | |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,7 |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | P | P | P | | P | 2 | P | P | P | | | 5.7 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
    | Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5.7 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
    | Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
    | 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 CWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    20 | 4D | Other
    [Notel |
    | Ophthalmic. | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7 |
    | Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,7 |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | 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

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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | | |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | P | P | P | | P | 2 | P | P | P | | | 4,5,7,1 | |
    | Trans-vaginal | P | P | P | | P | 2 | P | P | P | | | 4,5,7,1 | |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,7 | |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,7 | |
    | Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 5,7 | |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,7 | |
    | 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 Application
Specific

(Tracks 3)Mode of Operation
BMPWDCWDColor
DopplerCombined
(Specify)THIDynamic
FlowPowerCHI
2D4DOther 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | | 5,7,14.1 |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | | P | 2 | P | P | P | | | | 5,7,14.1 |
    | Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | | 5,7,14.1 |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | | 5,7.14.1 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7 |
    | Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,7 |
    | 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 Application
Specific
(Tracks 3) | Mode of Operation | | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    |------------------------------------------------|-------------------|--|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
    | Ophthalmic | | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | | |
    | Abdominal | | | P | P | P | | P | 2 | P | P | P | | | 5,7 |
    | Intra-operative (Abdominal) | | | P | P | P | | P | 2 | P | P | P | | | 5,7 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11 | |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11 | |
    | Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11 | |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11 | |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,14,15 |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,14,15 |
    | Musculo-skeletal
    (Superficial) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,14,15 |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,14,15 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)*THIDynamic
FlowPowerCHI
2D4DOther
[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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,11,
    15, |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,11,
    15 |
    | Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,11,
    15 |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,11,
    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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
    | Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
    | Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [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) | P | P | P | P | P | 3 | P | | | | | 4,13 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [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) | P | P | P | P | P | 3 | P | | | | | 4,13 |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)THIDynamic
FlowPowerCHI
2D4DOther
[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 CWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    Notel |
    | 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 | | | | P | | | | | | | | |
    | Cardiac Pediatric | | | | P | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | P | | | | | | | | |
    | 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)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [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 | | | P | | | | | | | | | |
    | Cardiac Pediatric | | | P | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | P | | | | | | | | | |
    | 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