APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001

K092179 · Toshiba America Medical Systems, In.C · IYN · Jul 29, 2009 · Radiology

Device Facts

• Record ID: K092179
• Device Name: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: IYN · Radiology
• Decision Date: Jul 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Aplio v4.0R001 is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectail, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

Device Story

The Aplio XG v4.0R001 is a mobile diagnostic ultrasound system used in clinical settings by healthcare professionals. It utilizes various probes (linear, convex, sector) with frequencies from 2 MHz to 12 MHz to acquire ultrasound signals. The system processes these inputs to generate diagnostic images and fluid flow data. A key feature is the Elastography function, which provides information on the relative elasticity of lesions. The system supports multiple imaging modes, including B-mode, M-mode, Pulsed Wave Doppler, Color Doppler, and others. Clinicians view the output on the system display to assess tissue characteristics and blood flow, aiding in clinical decision-making and diagnosis. The device benefits patients by providing non-invasive diagnostic imaging and tissue elasticity assessment.

Clinical Evidence

Bench testing only. The device was evaluated for safety and performance in accordance with recognized standards including IEC 60601-1, IEC 60601-2-37, and AIUM-NEMA UD2/UD3 output standards. No clinical trial data was required for this 510(k) submission.

Technological Characteristics

Mobile ultrasound system; frequency range 2-12 MHz; supports flat linear, convex, and sector array probes. Complies with IEC 60601-1, IEC 60601-2-37, IEC 62304, and AIUM-NEMA UD2/UD3 standards. Software-based image processing; connectivity via standard ultrasound interfaces.

Indications for Use

Indicated for determining the relative elasticity of a lesion in patients undergoing diagnostic ultrasound imaging or fluid flow analysis.

Regulatory Classification

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.

Predicate Devices

• Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V4.0 (K091295)
• Siemens Medical Solutions Acuson S2000 Diagnostic Ultrasound System (K090334)

Submission Summary (Full Text)

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10092179

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

# 510(k) Summary

JUL 2 9 2009 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 .: [phone]

Device Proprietary Name: Common Name: .

APLIO XG MODEL SSA-790A Version 4.0R001 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 t [Fed. Reg. No.: 892.1570]

# Identification of Predicate Devices:

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

- Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V4.0 510(k) K091295 .
- Siemens Medical Solutions Acuson S2000 Diagnostic Ultrasound System 510(k) K090334 .

# Device Description:

The Aplio XG v4.0R001 is a mobile system. This system 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

### Intended Use:

The Aplio v4.0R001 is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectail, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

# Safety Considerations:

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

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# 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), IEC 60601-2-37 (applicable portions), IEC 62304 (applicable porton) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard a

## Standards Forms:

The standards forms are the same as those submitted for the Aplio XG v4.0 K091295.

# Clinical Trials Form

Please see the attached Clinical Trials Form FDA-3674

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

JUL 2 9 2009

Re: K092179

Trade/Device Name: Elastography for SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: July 17, 2009 Received: July 21, 2009

Dear Mr. Job:

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

This determination of substantial equivalence applies to the following transducers intended for use with the Elastography for SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PLT-604AT PLT-704AT PLT-704SBT PLT-705BTH PLT-705BTF PLT-805AT PLT-1202S PLT-1204AT

PLT-1204BT PLT-1204AX PLT-1204BX PLT-1204MV PET-510MB PC-20M PC-50M PST-25BT

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| PST-30BT | PVT-575MV |
|-----------|------------|
| PST-50AT | PVT-674BT |
| PST-65AT | PVT-661VT |
| PVT-375BT | PVT-681MV |
| PVT-375MV | PVT-745BTV |
| PET-382BT | PVT-770RT |
| PVT-382MV | |

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

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Sunder Rajan at [phone].

Sincerely yours,

Janine M. Morris

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

Enclosure(s)

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510(k) Number (if known):

510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ültrasound System

Ko92179

Device Name: Elastography for SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System

Indications for Use:

Elastography is indicated for determining the relative elasticity of a lesion.

Prescription Use Only (Per 21 CRF801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

and Radiological Devices 510(k) Number.

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### 510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

### System: _ Aplio XG v4.0R001 SSA-790A Transducer: __________________________________________________________________________________________________________________________________________________________________

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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 Birl, BDTMDF, BDFMDFF, BDF/MDF/P WD
Note 3 Combined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; Note 4 TDI

.. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Note 5 ApliPure

Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color

Note 10 STIC Color

Note 11 Elastography (New)

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

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

### 510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

#### System: Aplio XG v4.0R001 SSA-790A Transducer: PLT-604AT

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

| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation<br>B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | | P | 2 | P | P | P | P | | 5 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | P | | 5 |
| 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 |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous SIO(k) of the transducer: K091295

Note { 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; BPWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/C Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801 109)

signature

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

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#### 510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer:___PLT-704AT

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

| Clinical Application | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---------|---------------|--------------------|-----|--------------|----------|--------|--------------|
| Specific (Tracks 3) | B | M | PWD/CWD | Color Doppler | Combined (Specify) | THI | Dynamic Flow | Power 2D | CHI 3D | 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 |
| 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 |
| Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | P | 5 |
| 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 |
| Other (Specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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/PWD; 2D/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 2) CRF801.109)

Hee Rem

(Division Šign-Off) Division of Reproductive, Abdominal. and Radiological Device

510(k) Number

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### 510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer:_ PLT-704SBT

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

| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | | P | 2 | P | P | P | P | | 5 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | P | | 5 |
| 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 |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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, BPWD; WD; BDF/MDF; BDF/MDFf/PWD; 2D/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color . (Division Sign-Off) Note 11 Elastography (New)

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

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

# 510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

#### System: _ Aplio XG v4.0R001 SSA-790A Transducer: PLT-705BTH

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

| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | P | | 5 |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | P | | 5 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | P | | 5 |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | P | | 5 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(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: K091295

Note I 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 Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Heflen

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

510(k) Number

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

#### 510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: ______________________________________________________________________________________________________________________________________________________________________ Aplio XG v4.0R001 SSA-790A Transducer:_ PLT-705BTF

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

| Clinical Application | Mode of Operation | | | | | | | | | | |
|------------------------------------|-------------------|---|---------|------------------|------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify)* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | 2 | P | P | P | P | | 5 |
| Intra-operative (Abdominal) | P | P | P | P | 2 | P | P | P | P | | 5 |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | P | 2 | P | P | P | P | | 5 |
| Small Organ (Specify) (1) | P | P | P | P | 2 | P | P | P | P | | 5 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skeletal<br>(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: K091295

. .

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 Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

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

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

# 510(k) Premarket Notification Aplio™ XG (v4.0R00!) SSA-790A Ultrasound System

System: Aplio XG v4.0R001 SSA-790A Transducer:_ PLT-805AT -----

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

| Clinical Application | Mode of Operation | | | | | | | | | Other<br>(Note) | |
|------------------------------------|-------------------|---|---------|------------------|-----------------------|-----|-----------------|-------|-----------|-----------------|-------|
| Specific<br>(Tracks 3) | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | | 3D |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | 2 | P | P | P | P | | 5,6,7 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | P | 2 | P | P | P | P | | 5,6,7 |
| Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | P | | 5,6,7 |
| 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 | P | | 5,6,7 |
| Other (Specify) | | | | | | | | | | | |

.. ... ...

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

….

i

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; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note II Elastography (New)

. .

Hui Rem
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K092179

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

.

### 510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

System: _ Aplio XG v4.0R001 SSA-790A Transducer:____PLT-1202S

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

| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|---------|------------------|------------------------|-----|-----------------|-------|-----------|----|-----------------|--|
| Specific<br>(Tracks 3) | B | M | PWD CWD | Color<br>Doppler | Combined*<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | P | P | P | P | 2 | P | P | P | | | 4,5,11 | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | 2 | P | P | P | | | 4,5,11 | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | P | 2 | P | P | P | | | 4,5,1 | |
| Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | | | 4,5,11 | |
| 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 | | | 4,5,1 | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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 & STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

·

Hut Rumen

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

51.0(k) Number.

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

### 510(k) Premarket Notification Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

#### System: _ Aplio XG v4.0R00I SSA-790A PLT-1204AT____ Transducer:

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

| Clinical Application | Mode of Operation | | | | | | | | | | |
|------------------------------------|-------------------|---|---------|------------------|-----------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | 2 | P | P | P | | | 4,5,6,1 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | P | 2 | P | P | P | | | 4,5,6,1 |
| Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | | | 4,5,6,1 |
| 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 | | | 4,5,6,1 |
| Other (Specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

.. . ...

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 Note 10 STIC Color Note 11 Elastography (New)

. .

.......

Prescription Use Only (Per 21 CRF801.109)

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

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

#### System: Aplio XG v4.0R001 SSA-790A Transducer: _ PLT-1204BT

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

| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,1 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,1 |
| Musculo-skeletal (Superficial). | P | P | P | | P | 2 | P | P | P | | | 4,5,6,1 |
| 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 | | | 4,5,6, |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

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 Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

Hellem

(Division Sign-Off)

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

) 10(k). Numbe

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

# 510(k) Premarket Notification

Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

Aplio XG v4.0R001 SSA-790A System: Transducer: PLT-1204AX____________________________________________________________________________________________________________________________________________________________________

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

| Clinical Application | Mode of Operation | | | | | | | Other<br>[Note] | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-------|-----------------|-----------------|-------|-----------|---------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI * | | Dynamic<br>Flow | Power | CHI<br>2D | 3D |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,1 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,1 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,1 |
| 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 | | | 4,5,6,1 |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous SIO(k) of the transducer: K091295

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; BDF/MDF/PWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BDF/CWD; BD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

H.D. Loum

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

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

# 510(k) Premarket Notification

Aplio™ XG (v4.0R001) SSA-790A Ultrasound System

#### System: Aplio XG v4.0R001 SSA-790A Transducer: PLT-1204BX

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

......

| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] | |
|------------------------------------------------|---|---|-----|-----|------------------|-----------------------|-----|-----------------|-------|-----------|----|-----------------|-----------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic…