APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0

K082119 · Toshiba America Medical Systems, In.C · IYN · Aug 12, 2008 · Radiology

Device Facts

• Record ID: K082119
• Device Name: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: IYN · Radiology
• Decision Date: Aug 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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

Device Story

The Aplio XG v3.0 is a mobile diagnostic ultrasound system. It utilizes various probes (linear, convex, sector arrays; 2-12 MHz) to acquire acoustic echo data. The system processes these inputs to generate B-mode, M-mode, Color Doppler, Power Doppler, Dynamic Flow, TDI, PW/CW Doppler, and harmonic imaging outputs. Operated by clinicians in clinical settings, the system provides real-time visualization of internal structures. Healthcare providers use these images to assess anatomy and pathology, supporting diagnostic decision-making. The device benefits patients by enabling non-invasive, real-time diagnostic imaging across a wide range of clinical applications.

Clinical Evidence

Bench testing only. The device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and AIUM-NEMA UD2/UD3 standards for acoustic output and safety. No clinical data was required for this clearance.

Technological Characteristics

Mobile diagnostic ultrasound system; Track 3 device. Probes: linear, convex, sector arrays (2-12 MHz). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AIUM-NEMA UD2, AIUM-NEMA UD3. Connectivity: standard ultrasound system interfaces. Sterilization: probes are reusable/disinfectable per manufacturer instructions.

Indications for Use

Indicated for diagnostic ultrasound imaging in fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional/superficial) 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 SSA-790A, Aplio XG Version 2.2 Diagnostic Ultrasound (K081065)
• Hitachi Medical Systems America Inc. HI VISION 900 Diagnostic Ultrasound Scanner (K063518)

Submission Summary (Full Text)

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

## 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92 1. And 1

| 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: SSA-790A, Aplio XG Version 3.0 Common Name: Diagnostic Ultrasound System

:

AUG 1 2 2008

### Classification:

Regulatory Class: II Review Category: Tier II

- Ultrasonic Pulsed Doppler Imaging System Product Code: 90-IYN [Fed. Reg. No.: . 892.15501
- 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:

- 1. Toshiba SSA-790A, Aplio XG Version 2.2 Diagnostic Ultrasound; 510(k) K081065
- 2. Hitachi Medical Systems America Inc. HI VISION 900 Diagnostic Ultrasound Scanner 510(k) K063518

#### Device Description:

The Aplio XG Ultrasound System 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 XG is intended to be used for the following types of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, 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 60601-1-2 (applicable portion), 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three human figures underneath. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9-2008

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

Re: K082119

Trade/Device Name: Aplio XG v3.0 SSA-790A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 26, 2008 Received: July 28, 2008

Dear Mr. Job:

This letter corrects our substantially equivalent letter of August 12, 2008.

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 XG v3.0 SSA-790A, as described in your premarket notification:

#### Transducer Model Number

| PVT-375BT | PET-510MB |
|-----------|-----------|
| PVT-661VT | PST-25BT |
| PLT-1202S | PLT-604AT |
| PC-20M | PLT-704AT |

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

| PLT-805AT | PLT-1204MV |
|------------|------------|
| PLT-1204AT | PVT-382MV |
| PLT-1204AX | PVT-681MV |
| PVT-382BT | PET-511BTM |
| PVT-674BT | PC-50M |
| PVT-575MV | PLT-705BTF |
| PVT-770RT | PLT-705BTH |
| PST-30BT | PLT-1204BT |
| PST-50AT | PLT-1204BX |
| PST-65AT | PVT-745BTV |
| PLT-704SBT | |

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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

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

Page 2 - Mr. Job

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 Lauren Hefner at [phone].

Sincerely yours,

Logu Mkhang

Joyce M. Whang, Ph.D. 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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Diagnostic Ultrasound Indic Thous For Use Form

System Transducer

Model & PVT-575MVAN Comments www.manage.com a

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | | P | | | | P |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K081065

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Evaluation (ODE)

Hebert Lewin

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

መጨረሻ መጨረሻ የሚያስተዋል። መልክ አይነት የመጣለት የሚያስተዋል። በማምጣት ነው። የ

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

Diagnostic Ultrasound Indications For

Transducer

Model PVT-770RT

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | | P | | | | P |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K081065

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Hulutten
Division Sign-Off

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

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

# Diagnostic Ultrasound Indications For Use Forn

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### Transducer X Model + PST-30BT =============================================================================================================================================================

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|--|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | P | | | P | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | P | |
| Small Organ (Specify)* | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | | P | |
| Cardiac | P | P | P | P | P | P | P | P | P | P | | P | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF

Previous S10{k) for this device K081065

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES NEE
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

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

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#### er (){ var legge कि है ్లో చ System Transducer X

# System PST-50AT --------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | | | P | P | P | | | P |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | | | P | P | P | | | P |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | P | P | P | P | | | P | P | P | | | P |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sigh-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

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

# . Diagnostic Ultrasound Indications For Use Form .

1889

Fransducer X

### Feller PST-65AThe ------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

:

1. 15. 12. 17. 12. 12. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2

18:578 : 1

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | | | P | P | P | | | P |
| Small Organ (Specify)* | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | | | P | P | P | | | P |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | P | P | P | P | | | P | P | P | | | P |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OPC)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

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

# iagnostic Ultrasound Indications Tor I

ransducer

Model -- PLT-704SBT

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | P | P | P | P | P | P | | P | | | | P |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | | P | | | | P |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | | P | | | | P |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | | P | | | | P |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

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

# . Diagnosne Ultrasound Indications For Use Edrin

#### ransdillo 204MV

#### e - - - - - - - - - - - - - - - - - - - - -510(k) Number(s)

| | | Mode of Operation | | | | | | | | | | | | |
|----------------------------------|---|-------------------|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|--|--|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | |
| Small Organ (Specify)* | P | P | P | P | P | P | P | P | | | | P | | |
| Neonatal Cephalic | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | | |
| Transurethra! | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | | | | P | | |
| Laparoscopic | | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | P | | | | P | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | P | | | | P | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K081065

(PLEASE DO NOT WRITE BEL

SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign Off) |
|---------------------|
|---------------------|

Prescription Use (Per 21 CFR 801.109)

(Uivision Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K682119 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

#### . Diagnostic Ultrasound Indication with art 10 - 1

ું પ્રતુ

, A - 1 - 7 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 的影院

STORES OF THE SEAR THE COLLECT TO THE COLLECT TO COLLECT TO COLLECT TO COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT

#### Transducer stem Model -- PVT-382MV ---------------------------------------------------------------------------------------------------

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | | |
|-------------------------------|-------------------|-----|---|---------------|-------|--------------|-----|----|----|--------|------------------|--------------------|--|
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | | P | | | | P | |
| Abdominal | P | P | P | P | P | P | | P | | | | P | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | | P | | | | P | |
| Small Organ (Specify)* | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K0810650

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NE Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

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

# Diagnostic Ultrasound Indications For Use Form .

# Model PVT-681MV

ransdi

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | | |
|---------------------------------|-------------------|-----|---|---------------|-------|--------------|-----|----|----|--------|------------------|--------------------|---|
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | | P | | | | | P |
| Transvaginal | P | P | P | P | P | P | | P | | | | | P |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | | |
| Conventional | | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K081065

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

Prescription Use (Per 21 CFR 801.109)

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

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

Diagnostic Ultrasound Indications Cor Use Form

System -----------------------------------------------------------------------------------------------------------------------------------------------------------------------", " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | | |
|--------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|--|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | | | P | P | P | | | P | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | | |
| Conventional | | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | |
|---------------------------------------|--------------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal and |
| | Radiological Devices |
| 510(k) Number | 15082119 |
| | <img alt="Signature" src="signature.jpg"/> |

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

Diagnostic Uli sound l ੍ਹਾ ਗਿ

System "Tra

Model PC-50M

510(k) Number(s)

- 33-

| | <b>Mode of Operation</b> | | | | | | | | | | | | |
|----------------------------------|--------------------------|-----|---|---------------|-------|--------------|-----|----|----|--------|------------------|--------------------|--|
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | P | | | | |
| Small Organ (Specify)* | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | P | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | P | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments:

Previous 510(k) for this device k081065

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices ા તા 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

## Diagnostic Ultrasound Indications For Use Form

Transducer _X System_ PLT-705BTF Model 510(k) Number(s)

| Mode of Operation | | | | | | | | | | | | |
|-------------------------------|---|-----|---|---------------|-------|--------------|-----|----|----|--------|------------------|--------------------|
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | | N | | | | N |
| Intraoperative (Specify) | N | N | N | N | N | N | | N | | | | N |
| Intraoperative | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | N | N | N | N | N | N | | N | | | | N |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: ____________ Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number K082119

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

### Diagnostic Ultrasound Indications For Use Form

Transducer _X System _ PLT-705BTH Model 510(k) Number(s)

| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) |
|-------------------------------|---|-----|---|---------------|-------|--------------|-----|----|----|--------|------------------|--------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | | N | | | | N |
| Intraoperative (Specify) | N | N | N | N | N | N | | N | | | | N |
| Intraoperative | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify)* | N | N | N | N | N | N | | N | | | | N |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:
BDF/PWD; BDF/MDF; BDF/MDF/PWD
Combined Modes: B/M; B/PWD;Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

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

# iagnostic Ultrasound Indications For Use Form

ות מאי

State State of the markets of the state and the

. . P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12:27:54

#### ransducer X min - 1 1 % to em 204B Model

#### ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

| | | Mode of Operation | | | | | | | | | | | | |
|----------------------------------|---|-------------------|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|--|--|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | |
| Small Organ (Specify)* | N | N | N | N | N | N | N | N | N | N | N | N | | |
| Neonatal Cephalic | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N | N | | |
| Laparoscopic | | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | N | N | N | N | N | N | N | N | N | N | N | N | | |
| Musculo-skeletal<br>Conventional | N | N | N | N | N | N | N | N | N | N | N | N | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (QD) (Division Sign-Off) Prescription Use (Per 21 CFR 801.109) Division of Reproductive, Abdomina

> Radiological Devices 510(k) Number

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

### Diagnostic Ultrasound Indications For Use Form

System X Transducer Aplio XG v3.0 SSA-790A_ Model 510(k) Number(s)

Carlos Concession Consideration of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Chil

| | | Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|-------------------|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|--|
| Clinical Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | | P | | | | P | |
| Abdominal | P | P | P | P | P | P | | P | P | | | P | |
| Intraoperative (Specify) | P | P | P | P | P | | | P | | | | P | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | P | |
| Small Organ (Specify)* | P | P | P | P | P | N | N | P | | | | P | |
| Neonatal Cephalic | P | P | P | P | P | P | | P | P | | | P | |
| Adult Cephalic | P | P | P | P | P | P | | P | P | | | P | |
| Cardiac | P | P | P | P | P | P | P | P | P | P | | P | |
| Transesophageal | P | P | P | P | |…