APLIO ARTIDA V2.0 SSH-880CV

K090158 · Toshiba America Medical Systems, In.C · IYN · Feb 6, 2009 · Radiology

Device Facts

• Record ID: K090158
• Device Name: APLIO ARTIDA V2.0 SSH-880CV
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: IYN · Radiology
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: cardiac, transesophageal, abdominal and peripheral vascular.

Device Story

Mobile diagnostic ultrasound system (Track 3) utilizing wide range of probes (flat linear/sector arrays, 2.5-7.5 MHz). System captures acoustic signals, processes data, and displays real-time images/flow analysis for clinical assessment. Used in clinical settings by trained healthcare professionals. Output aids in visualization and diagnosis of cardiac, abdominal, and vascular structures. Benefits include non-invasive diagnostic imaging and hemodynamic assessment.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with safety standards (IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-37) and AIUM-NEMA output measurement/display standards (UD2, UD3) confirmed.

Technological Characteristics

Mobile ultrasound system; frequency range 2.5-7.5 MHz; probes include flat linear and sector arrays. Complies with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-37, and AIUM-NEMA UD2/UD3 standards. Track 3 device.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in cardiac (adult/pediatric), transesophageal (cardiac), abdominal, and peripheral vascular applications. Prescription use only.

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 Artida v2.0 SSH-880CV (K080160)
• Toshiba Ultrasound Diagnostic System Aplio XG SSA-790A V3.0 (K082119)

Submission Summary (Full Text)

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

FEB - 62009

K090188

Toshiba America Medical Systems, Inc.

510(k) Premarke: Notification Aplio™ Artida (v2.0) SSH-880CV Ultrasound System

# 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 of Regulatory Affairs Telephone No .: [phone]

Device Proprietary Name: Aplio Artida v2.0 SSH-880CV Common Name: Diagnostic Ultrasound System

Classification:

- Regulatory Class: II A
- Review Category: Tier II
- . Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Federal Reg. No .: 892.1550]
- Ultrasonic Pulsed Echo Imaging System Product Code: 90-IYO . [Federal Reg. No .: 892.1560]
- Diagnostic Ultrasonic Transducer Product Code: 90-ITX . [Federal 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 Artida v2.0 SSH-880CV; 510(k) K080160. ◆
- . Toshiba Ultrasound Diagnostic System Aplio XG SSA-790A V3.0; 510(k) K082119.

#### Device Description:

This device is a mobile system is a Track 3 device that employs a wide range of probes that include flat linear array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.

#### Indication of Use:

This device is intended to be used for the following type of studies; cardiac, transesophageal, abdominal and peripheral vascular.

#### 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 portions), IEC 60601-1-2 (applicable portion), IEC 60601-1-4 (applicable portions), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

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

Image /page/1/Picture/0 description: The image shows the text "510(k) Premarket Notification". The text is in a simple, sans-serif font. Above the text is a dark, irregular shape that appears to be an obscured image or logo.

Aplio™ Artida (v2.0) SSH-880CV Ultrasound System

# ' Standards Form:

(

Please see the attached standard form of the IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4 and IEC 60601-2-37.

# Reason for Submission:

There is no new clinical application. The indication of use "abdominal" is added to the Indication of Use.

# Submission Type:

This device is a Track 3 device. The submission type is Track 3.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Re: K090158

Trade/Device Name: Aplio Artida v2.0 SSH-880CV Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 21, 2009 Received: January 22, 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.

EB - 6 2009

This determination of substantial equivalence applies to the following transducers intended for use with the Aplio Artida v2.0 SSH-880CV, as described in your premarket notification:

Transducer Model Number

PST-25SX PST-30BT PST-30SBT PST-50BT PST-65AT PLT-704SBT

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

# PET-511BTM PC-20M

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 John Chen at [phone].

Sincerely yours,

Helene Leun
Janine M. Morris

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

#### Enclosure(s)

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

#### 510(k) Premarket Notification Aplio™ Artida (v2.0) SSH-880CV Ultrasound System

# Diagnostic Ultrasound Indications For Use Form

System: __Aplio Artida v2.0 SSH-880CV 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)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | P | P | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | P | P | | | |
| Musculo-skeletal (Superficial) | P | P | P | | P | P | P | P | P | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | N | N | P | P | P |
| Cardiac Pediatric | P | P | P | P | P | P | P | N | N | P | P | P |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | | | P | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | P | P | | | |
| Other (Specify) | | | | | | | | | | | | |

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

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

Previous 510(k) of the transducer: K080160

Pr

Prescription Use Only (Per 21 CFR 801:109)

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

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

#### 510(k) Premarket Notification Aplio™ Artida (v2.0) SSH-880CV Ultrasound System

# Diagnostic Ultrasound Indications For Use Form

System: Aplio Artida v2.0 SSH-880CV Transducer: PST-25SX

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 | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | | | | | P | | | | | P | |
| Cardiac Pediatric | P | | | | | P | | | | | P | |
| 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 *Combined mode includes B/M, B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Previous 510(k) of the transducer: K080160

Pr

Prescription Use (Per 21 CFR 801.109)

(División Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090158

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

.

. .

# Diagnostic Ultrasound Indications For Use Form

System: __Aplio Artida v2.0 SSH-880CV Transducer:___ PST-30BT 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----|-----------|------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | N | N | N | N | N |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | N | N | N | N |
| 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 *Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Prescription Use Only (Per 21 CFR 801.109)

Tony M. Why

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

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

.

# Diagnostic Ultrasound Indications For Use Form

System: _ Aplio Artida v2:0 SSH-880CV Transducer: PST-30SBT

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 | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | | | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | | | P | P | |
| 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 *Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Previous 510(k) of the transducer: K080160

Prescription Use Only (Per 21 CFR 801.109)

Prescription

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

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

# Diagnostic Ultrasound Indications For Use Form

System: __Aplio Artida v2.0 SSH-880CV Transducer:__ PST-50BT

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 | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | | | N | | |
| Cardiac Pediatric | N | N | N | N | N | N | N | | | N | | |
| 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 *Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Prescription Use Only (Per 21 CFR 801.109)

louis M. Whang

(Division Sigh-Off) Division of Reproductive, Abdominal and adiological Devices 09015 510(k) Number

·

关系

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

# Diagnostic Ultrasound Indications For Use Form

#### System: __Aplio Artida v2.0 SSH-880CV Transducer:___ PST-65AT

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 | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | | | N | | |
| Cardiac Pediatric | N | N | N | N | N | N | N | | | N | | |
| 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 *Combined mode includes B/M; B/P/WD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Prescription Use Only (Per 21 CFR 801.109)

tony M. Whang

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

.

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

# Diagnostic Ultrasound Indications For Use Form

System: __ Aplio Artida v2.0 SSH-880CV 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)<br>* | THI | Dynamic<br>Flow | Power | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | P | P | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | P | P | P | P | P | P | | | |
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | P | P | P | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | P | P | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix *Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Previous 510(k) of the transducer: K080160

Prescription

Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090158

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

## 510(k) Premarket Notification Aplio™ Artida (v2.0) SSH-880CV Ultrasound System

# Diagnostic Ultrasound Indications For Use Form

#### System: Aplio Artida v2.0 SSH-880CV Transducer: PET-511BTM

.

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 | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | | | P | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix *Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

-- ·

Previous 510(k) of the transducer: K080160

" "

Prescription Use Only (Per 21 CFR 801.109)

Longworth Withers

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Kogo158 510(k) Number

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

# Diagnostic Ultrasound Indications For Use Form

#### System: Aplio Artida v2.0 SSH-880CV Transducer:_ PC-20M

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 | TDI | CHI<br>2D | 4D<br>(Realtime<br>3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | P | | | | | | | |
| Cardiac Pediatric | | | | | P | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix *Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Previous 510(k) of the transducer: K080160

Proscription Use Only (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices K090158 510(k) Number __