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K Number
K110870
Device Name
APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
2011-10-04

(189 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System 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, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).
Device Description
The Aplio 500/400/300 system is a mobile ultrasound system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz. The Aplio 500/400/300 is designed to support a wide rauge of applications depending on which software is installed. The system can be a dedicated system or a eneral purpose system.
More Information

K 103645, K090158, K092271

Not Found

No
The provided 510(k) summary does not mention AI, ML, or any related terms in the device description, intended use, or other sections. The description focuses on standard ultrasound technology and its applications.

No
The "Intended Use / Indications for Use" section explicitly states that the device is a "Diagnostic Ultrasound System" indicated for "visualization of structures, and dynamic processes... and to provide image information for diagnosis." It does not mention any therapeutic capabilities.

Yes

The "Intended Use / Indications for Use" section explicitly states "The Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System is indicated... to provide image information for diagnosis".

No

The device description explicitly states it is a "mobile ultrasound system" that "employs a wide array of probes," indicating it includes hardware components beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "visualization of structures, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis". This describes an in vivo diagnostic process (examining the body directly), not an in vitro process (examining samples outside the body).
  • Device Description: The description details a mobile ultrasound system that uses probes to interact with the human body. This is consistent with an in vivo imaging device.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.

Therefore, the Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System is an in vivo diagnostic imaging device, not an IVD.

N/A

Intended Use / Indications for Use

The system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and sugerficial).

The Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System 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, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: As listed for each transducer.

  • PLT-1202S: Intra-operative (Abdominal); Small Organ (includes thyroid, breast and testicle); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral vessel
  • PLT-1204BT: Small Organ (includes thyroid, breast and testicle); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral vessel
  • PLT-1204BX: Small Organ (includes thyroid, breast and testicle); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral vessel
  • PLT-1204MV: Small Organ (includes thyroid, breast and testicle); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral vessel
  • PET-510MB: Trans-esoph. (Cardiac)
  • PC-20M: Cardiac Adult; Cardiac Pediatric; Peripheral vessel
  • PC-50M: Cardiac Adult; Cardiac Pediatric; Peripheral vessel
  • PST-25BT: Abdominal; Pediatric; Neonatal Cephalic; Adult Cephalic; Cardiac Adult; Cardiac Pediatric
  • PST-30BT: Abdominal; Pediatric; Neonatal Cephalic; Adult Cephalic; Cardiac Adult; Cardiac Pediatric
  • PVT-375BT: Fetal; Abdominal; Pediatric
  • PVT-375MV: Fetal; Abdominal; Pediatric
  • PVT-382BT: Fetal; Abdominal; Pediatric
  • PVT-382MV: Ophthalmic (Color Doppler only); Fetal; Abdominal; Pediatric
  • PVT-661VT: Trans-rectal; Trans-vaginal
  • PVT-674BT: Fetal; Abdominal; Pediatric
  • PVT-675MV: Fetal; Abdominal; Pediatric
  • PVT-681MV: Trans-rectal; Trans-vaginal
  • PLT-712BT: Abdominal; Pediatric; Neonatal Cephalic
  • PLT-745BTV: Abdominal; Intra-operative (Abdominal)
  • PLT-704SBT: Small Organ (includes thyroid, breast and testicle); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral vessel
  • PLT-805AT: Small Organ (includes thyroid, breast and testicle); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral vessel

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

90-IYN, 90-IYO, 90-ITX, IYO, IYN, ITX

Device Description

The Aplio 500/400/300 system is a mobile ultrasound system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz. The Aplio 500/400/300 is designed to support a wide rauge of applications depending on which software is installed. The system can be a dedicated system or a eneral purpose system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

  • Fetal
  • Abdominal
  • Intraoperative
  • Pediatric
  • Small organs
  • Neonatal cephalic
  • Adult cephalic
  • Cardiac
  • Transrectal
  • Transvaginal
  • Transesophageal
  • Peripheral vascular
  • Musculo-skeletal (both conventional and superficial)

Indicated Patient Age Range

  • Fetal
  • Pediatric
  • Neonatal Cephalic
  • Adult Cephalic
  • Cardiac Adult
  • Cardiac Pediatric

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)

Not Found

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.

K 103645, K090158, K092271

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.

Not Found

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

Aplio™ TUS-A300/400/500 (v2.0)

OCT - 4 2011

510(k) Summary

Submitter's Name: Toshiba America Medical Systems, Inc. Address: PO Box 2068, 2441 Michelle Drive Tustin, CA 92781-2068 Contact: Paul Biggins, Director Regulatory Affairs Telephone No .: (714) 730-5000 Preparation Date: September 30, 2011 Device Proprietary Name: Diagnostic Ultrasound System Aplio 500 Model TUS-A500 Version 2.0 Aplio 400 Model TUS-A400 Version 2.0 Aplio 300 Model TUS-A300 Version 2.0 Common Name: Diagnostic Ultrasound System

Classification:

  • Regulatory Class: II ●
  • . Review Category: Tier II
  • Ultrasonic Pulsed Doppler Imaging System Product Code: 90-IYN . [Fed. Reg. No .: 892.1550]
  • Ultrasonic Pulsed Echo Imaging System Product Code: 90-IYO . [Fed. Reg. No .: 892.1560]
  • . Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed. Reg. No.: 892.1570]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to:

  • K 103645 Toshiba Diagnostic System Aplio XG SSA-790A v5.2 .
  • K090158 Toshiba Diagnostic Ultrasound system Aplio Artida SSH-880A v2.0 ●
  • K092271 General Electric LOGIC E.9 Ultrasound System .

Device Description:

The Aplio 500/400/300 system is a mobile ultrasound system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz. The Aplio 500/400/300 is designed to support a wide rauge of applications depending on which software is installed. The system can be a dedicated system or a eneral purpose system.

Intended Use:

The system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and sugerficial).

Declaration of Conformity:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1 (applicable portion), IEC 60601-1-2 (applicable portion), IEC 60601-1-4 (applicable portion), IEC60601-2-37 (applicable portions), IEC 62304 (applicable portion),

1

and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

Testing has been conducted per the following standards:

  • . IEC 60601-1-1
  • IEC 60601-1 .
  • . IEC 60601-2-37
  • . IEC 60601-1-4
  • . IEC 62304

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is an emblem featuring a stylized depiction of a bird or eagle with outstretched wings.

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

Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

. . . .

OCT - 4 2011

Re: K110870

Trade/Device Name: Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Il Product Code: 1YO. IYN, and ITX Dated: August 10, 2011 Received: August 11, 2011

Dear Mr. Biggins:

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

This determination of substantial equivalence applies to the following transducers intended for use with the Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System, as described in your premarket notification:

PLT-1202SPST-25BTPVT-674BT
PLT-1204BTPST-30BTPVT-675MV
PLT-1204BXPVT-375BTPVT-681MV
PLT-1204MVPVT-375MVPLT-712BT
PET-510MBPVT-382BTPLT-745BTV
PC-20MPVT-382MVPLT-704BT
PC-50MPVT-661VTPLT-805AT

3

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

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

If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.

Sincerely Yours,

Mary Stoth

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

Enclosure(s)

4

K 110870 510(K) Number (if known):

Device Name: Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System

Indications for Use:

The Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System 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, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).

Prescription Use_

AND/OR

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

(Part 21 CFR 801 Subpart D)

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

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

Mary Shiotl

Radiological Devices Division of Office of in Vitro D

K110870
510K

COMPANY CONFIDENTIAL MAR 2011

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System: _Aplio TUS-A500/A400/A300 v2.0 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)*THIDynamic
FlowPowerCHI
2D4DOther
[Note]
Ophthalmic
FetalNNNNN2NNNNN5,7
AbdominalNNNNN2,3NNNNN5,7,12
Intra-operative (Abdominal)NNNNN2NNNN4,5
Intra-operative (Neuro)
Laparoscopic
Pediatric*NNNNN2,3NNNNN5,7,12
Small Organ (Note 1)NNNNN2NNNN4,5,6,7,11
Neonatal CephalicNNNNN3NNNN
Adult CephalicNNNNN3NNNN
Trans-rectalNNNNN2NNNNN4,5,7,11
Trans-vaginalNNNNN2NNNNN4,5,7
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)NNNNN2NNNN4,5,6,7,11
Musculo-skeletal (Superficial)NNNNN2NNNN4,5,6,7,11
Intravascular
Other (Specify)
Cardiac AdultNNNNN3NNNNN4
Cardiac PediatricNNNNN3NNNNN4
Intravascular (Cardiac)
Trans-esoph. (Cardiac)NNNNN3N4
Intra-cardiac
Other (Specify)
Peripheral vesselNNNNN2NNNN4,5,6,7,11
Other (Specify)

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

Previous 510(k) of the transducer: K103645

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

Prescription Use Only (Per 21 CRF801.109)

Mary S. Posth
(Division Sign Off)

Division of Radiological Device Office of In Vitro Division of nazioning of Includion

K110870
510K

COMPANY CONFIDENTIAL MAR 2011

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510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System

Aplio TUS-A500/A400/A300 v2.0 System: _ 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)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    Note |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal (Conventional) | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
    | Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | N | N | N | N | N | 2 | N | | N | | | 4,5,11 |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645

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

Prescription Use Only (Per 21 CRF801.109)

Mary S. Posth

Division of Radiological Devic Office of In

510K K110870

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COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 180 of 3030

7

510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System

. --

System: Aplio TUS-A500/A400/A300 v2.0 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) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 | |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 | |
    | Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 | |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 | |
    | Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645

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 13 2D WMT

  • 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
    Mary S Patel
    (Division Sign-Off)

Division of Aadiological Devices stic Device Evaluation and Safety Office of In Vitro Diagno

K110870
510K

Prescription Use Only (Per 21 CRF801.109)

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COMPANY CONFIDENTIAL MAR 2011

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8

510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System

System: _ Aplio TUS-A500 v2.0 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) | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 5.7 |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645

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

Prescription Use Only (Per 21 CRF801.109)

Mary Statel
(Division Sign-Off)

Office of In

510K K110870

B-19

9

510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System

System: _ Aplio TUS-A500/A400/A300 v2.0 Transducer:___PLT-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) | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 | |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 | |
    | Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 | |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 | |
    | Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645

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
    Mary S. Pastel

ADVISION Sign-Off ivision of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110870

Prescription Use Only (Per 21 CRF801.109)

B-20

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 183 of 3030

10

510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System

System: Aplio TUS-A500/A400/A300 v2.0 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)*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)NNNNN3N4,13
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: K103645

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

Mary S. Patel

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

K110870
510K

Prescription Use Only (Per 21 CRF801.109)

B-21

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 184 of 3030

11

510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System

System: Aplio TUS-A500/A400/A300 v2.0 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)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 AdultN
Cardiac PediatricN
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselN
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645

Note 1 Small organ includes thyroid, breast and testicle.

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

Mary S. Poole
(Division Sign-Off)

Division of Radiological Devices Office of In

510K K110870

Prescription Use Only (Per 21 CRF801.109)

B-22

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 185 of 3030

12

510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System

System: Aplio TUS-A500/A400/A300 v2.0 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)BMPWD CWDColor
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 AdultN
Cardiac PediatricN
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselN
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645

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 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

Prescription Use Only (Per 21 CRF801.109)

Mary S. Patel

vision Sign-Off) Division of Radiological Devices ice Evaluation and Safety Office of In Vitro Diag

510K K110870

cription Use Only (ref 21 CRF 801.109)

B-23

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 186 of 3030

Note 4 TDI

13

510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)

System: Aplio TUS-A500/A400/A300 v2.0 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)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | N | N | N | N | N | 3 | N | N | N | | | 11 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | N | N | 3 | N | N | N | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
    | Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4,13 |
    | Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 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: K103645

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

Mary S. Poole
(Division Sign-Off)

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

510K H110870

COMPANY CONFIDENTIAL MAR 2011

Prescription Use Only (Per 21 CRF801.109)

B-3

510(k): Aplio TUS-A500/400/300 (V2.0) Page 166 of 3030

14

510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)

System: Aplio TUS-A500/A400/A300 v2.0 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 | N | N | N | N | N | 3 | N | N | N | | | 11 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | N | N | 3 | N | N | N | | | |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
    | Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4,13 |
    | Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 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: K103645

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 (Division Sign-Off, Note 11 Elastography Note 12 Fusion Note 13 2D WMT

Prescription Use Only (Per 21 CRF801.109)

Mary Stastil
(Division Sign-Off)

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

510K H110870

COMPANY CONFIDENTIAL MAR 2011

B-4

510(k): Aplio TUS-A500/400/300 (V2.0) Page 167 of 3030

15

510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)

System: Aplio_TUS-A500/A400/A300 v2.0 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 | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5, 7,11,12 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | N | N | 2 | N | N | N | | | 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: K103645

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 ton Sign-Off Note 11 Elastography Office of In Vitro Diagnostic Note 12 Fusion Note 13 2D WMT 510K

Prescription Use Only (Per 21 CRF801.109)

Mary Slatel
(Division Sign Off)

Division of Radiological Devices

510K K110870

COMPANY CONFIDENTIAL MAR 2011

B-ર

510(k): Aplio TUS-A500/400/300 (V2.0) Page 168 of 3030

16

510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)

System: ______________________________________________________________________________________________________________________________________________________________________ Transducer:_ PVT-375MV ﺮ ﻣﻦ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ

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 | N | N | N | | N | 2 | N | N | N | | N | 5,7,8,9,10 |
    | Abdominal | N | N | N | | N | 2 | N | N | N | | N | 5,7,8,9,10 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | | N | 2 | N | N | N | | 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: K103645

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

Prescription Use Only (Per 21 CRF801.109)

Mary Postel
(Division Sign-Off)

Division of Radiological Devices tro Diagnostic Device Evaluation and Safety Office of Ir

510K. K110820

COMPANY CONFIDENTIAL MAR 2011

B-6

510(k): Aplio TUS-A500/400/300 (V2.0) Page 169 of 3030

17

System: _Aplio TUS-A500/A400/A300 v2.0 Transducer: PVT-382BT

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)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | 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: K103645

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

MAR 2011

Mary S. Pastels

ion Sign-Off (Divi Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sefety

510K K110870

Prescription Use Only (Per 21 CRF801.109)

COMPANY CONFIDENTIAL

B-7

510(k): Aplio TUS-A500/400/300 (V2.0) Page 170 of 3030

18

510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)

System: Aplio TUS-A500/A400/A300 v2.0 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 | | | | | N | | | | | | | |
    | Fetal | N | N | N | N | N | 2 | N | N | N | N | N | 5,7,9 |
    | Abdominal | N | N | N | N | N | 2 | N | N | N | N | N | 5,7,9 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | N | N | 2 | N | N | N | N | N | 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: K103645

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
    Prescription Use Only (Per 21 CRF801.109)

Mary S. Patel
(Division Sign Off)

sion Sign Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sefety

510K. h110870

COMPANY CONFIDENTIAL MAR 2011

B-8

510(k): Aplio TUS-A500/400/300 (V2.0) Page 171 of 3030

19

510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)

System: Aplio TUS-A500/A400/A300 v2.0 Transducer: PVT-661VT

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)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 | N | N | N | N | N | 2 | N | N | N | | | 4,5,7,11 |
    | Trans-vaginal | N | N | N | N | N | 2 | N | N | N | | | 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: K103645

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

Mary S. Pastell

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

510K 110870

Prescription Use Only (Per 21 CRF801.109)

COMPANY CONFIDENTIAL MAR 2011

B-9

510(k): Aplio TUS-A500/400/300 (V2.0) Page 172 of 3030

20

510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)

Aplio TUS-A500/A400/A300 v2.0 System: _ 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 | N | N | N | N | N | 2 | N | N | N | | | 5.7 |
    | Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5.7 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | 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: K103645

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

Prescription Use Only (Per 21 CRF801.109)

Mary Stodd

h Sign-O Civision of Gadiological Devices in in vitre blagnostic De

K110870

COMPANY CONFIDENTIAL MAR 2011

B-10

510(k): Aplio TUS-A500/400/300 (V2.0) Page 173 of 3030

21

510(k) Premarket Notification Aplio™ TUS-A500/300/200 (v2.0)

System: __ Aplio TUS-A500/A400/A300 v2.0 Transducer: PVT-675MV

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 | | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 |
    | Abdominal | | N | N | N | N | N | 2 | N | N | N | | N | 5,7,8,9,1 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | N | N | N | N | N | 2 | N | N | N | | N | 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: K103645

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; 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 II Elastography Note 12 Fusion

Note 13 2D WMT

Prescription Use Only (Per 21 CRF801.109)

Mare Slastel
(Division Sign-Off)

Division a and Sefety Office of In

510K K110870

COMPANY CONFIDENTIAL MAR 2011

B-11

510(k): Aplio TUS-A500/400/300 (V2.0) Page 174 of 3030

22

510(k) Premarket Notification Aplio™500(v2.0)TUS-A500 Ultrasound System

System: _Aplio TUS-A500/A400/A300 v2.0 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 | N | N | N | N | N | 2 | N | N | N | N | N | 4,5,7,9,1 |
    | Trans-vaginal | N | N | N | N | N | 2 | N | N | N | N | N | 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: K103645

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
    Mary Stotes

on Sigi Division of Radiological Devices Office of In Vitro Diagno

510K K110870

Prescription Use Only (Per 21 CRF801.109)

B-12

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 175 of 3030

e = mc²

23

System: Aplio TUS-A500/A400/A300 v2.0 Transducer: PLT-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 | N | N | N | | N | 2 | N | N | N | | | 5,7 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | | N | 2 | N | N | N | | | 5,7 |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | N | N | N | | N | 2 | N | N | N | | | 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: K103645

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

Mury S. Postel

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

510K. K110870

Prescription Use Only (Per 21 CRF801.109)

B-13

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 176 of 3030

24

System: Aplio TUS-A500/A400/A300 v2.0 Transducer:___ PLT-745BTV

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 | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Intra-operative (Abdominal) | N | N | N | N | N | 2 | N | N | N | | | 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: K103645

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

Prescription Use Only (Per 21 CRF801.109)

Mary Pastel

(Division Sign-Off)

Division of Radiological Device Office of Ir valuation and Safety

510K K110870

B-14

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 177 of 3030

25

System: Aplio_TUS-A500/A400/A300 v2.0 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) | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
    | Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 5.7 |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | | 5.7 |
    | Other (Specify) | | | | | | | | | | | | |

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

Previous 510(k) of the transducer: K103645

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

Prescription Use Only (Per 21 CRF801.109)

Mary S Patel
(Division Sign-Off)

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

510K K110870

B-15

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 178 of 3030

26

510(k) Premarket Notification Aplio™500(v2.0) TUS-A500 Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ 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)THIDynamic
FlowPowerCHI
2D4DOther
[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)NNNNN2NNN5,6,7,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)NNNNN2NNN5,6,7,11
Musculo-skeletal (Superficial)NNNNN2NNN5,6,7,11
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselNNNNN2NNN5,6,7,11
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103645

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 Office of In Vitro Note 13 2D WMT

Prescription Use Only (Per 21 CRF801.109)

Mary S Pastel
(Division Sign-Off)

K110870
510K.

B-16

COMPANY CONFIDENTIAL MAR 2011

510(k): Aplio TUS-A500/400/300 (V2.0) Page 179 of 3030