SSA-770A, APLIO VERSION 5.5

K041499 · Toshibamedical Systems Corporation · IYN · Jun 10, 2004 · Radiology

Device Facts

• Record ID: K041499
• Device Name: SSA-770A, APLIO VERSION 5.5
• Applicant: Toshibamedical Systems Corporation
• Product Code: IYN · Radiology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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

Device Story

APLIO (SSA-770A) is a mobile diagnostic ultrasound system; utilizes wide array of probes (2-12 MHz) including linear, convex, and sector arrays. System captures acoustic signals; processes data to generate B-mode, M-mode, Pulsed Wave Doppler, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Harmonic Imaging, and Tissue Doppler Imaging (TDI-Q). Used in clinical settings (clinics, hospitals) by trained healthcare professionals. Output displayed on monitor for real-time visualization; assists clinicians in diagnostic assessment of anatomy and blood flow. Benefits include non-invasive diagnostic imaging across diverse clinical applications.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and adherence to recognized standards, including IEC 60601, IEC 60601-2-37, and AIUM-NEMA UD2/UD3 output measurement and display standards.

Technological Characteristics

Mobile ultrasound system; frequency range 2-12 MHz; probes include flat linear, convex, and sector arrays. Complies with IEC 60601, IEC 60601-2-37, and AIUM-NEMA UD2/UD3 standards. Supports multiple imaging modes (B, M, Doppler, Harmonic, TDI).

Indications for Use

Indicated for fetal, abdominal, intraoperative, pediatric, small organ (thyroid, parathyroid, breast, scrotum, penis), neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vascular, laparoscopic, and musculoskeletal (conventional/superficial) imaging.

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-770A, Aplio Version 4.0 Diagnostic Ultrasound (k032281)
• Siemens Medical Solutions Sequoia 8.0 Diagnostic Ultrasound System (k032281)

Reference Devices

• Toshiba SSA-700A (k022400)
• Previous 510(k) for this device (k013633)

Submission Summary (Full Text)

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K041499

### (JUN 1 0 2004

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

| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|--------------------------|--------------------------------------------------------------------------------------------|
| Address: | PO Box 2068,2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Paul Biggins, Sr. Manager of Regulatory Affairs |
| Telephone No.: | [phone] |
| Device Proprietary Name: | SSA-770A, APLIO Version 5.5 |
| Common Name: | Diagnostic Ultrasound System |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Tier II |
| | Ultrasonic Pulsed Doppler Imaging System -- Product Code: 90-IYN<br>[Fed.Reg.No.:892.1550] |
| | Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO<br>[Fed.Reg.No.:892.1560] |
| | Diagnostic Ultrasonic Transducer – Product Code: 90-ITX<br>[Fed.Reg.No.:892.1570] |

#### Identification of Predicate Devices:

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

- 1) Toshiba SSA-770A, Aplio Version 4.0 Diagnostic Ultrasound; 510(k) control number k032281
- 2) Siemens Medical Solutions Sequoia 8.0 Diagnostic Ultrasound System; 510(k) control number k032281

#### Device Description:

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

#### Safety Considerations:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601 (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.

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### JUN 1 0 2004

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

Re: K041499

K041477
Trade Name: APLIO Diagnostic Ultrasound System, Model SSA-770A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: June 4, 2004 Received: June 7, 2004

#### Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(K) prematerially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regars atment date of the Medical Device Amendments, or to commerce prior to May 20, 1970, the enability with the provisions of the Federal Food, Drug, and devices that nave been receasined in are reader we device, subject to the general controls Cosment Act (Act). Tou may, mercrors, in the Act include requirements for annual provisions of the Act. "The general vehiclering practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use I ins determination of savstanial oqur allers upposes in the many of the many of the many of notification:

#### Transducer Model Number

| PST-25AT | PLT-1204AX | PST-37CT |
|-----------|------------|-----------|
| PVT-375AT | PC-20M | PST-30BT |
| PVT-661VT | PET-510MB | PLT-704AT |
| PLT-805AT | PLT-1202S | PLT-1204A |
| PST-20CT | PET-704LA | PVT-375AX |

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| PST-65AT | PLT-308P | PVT-375BT |
|-----------|-----------|-----------|
| PLT-604AT | PET-508MA | PVT-382BT |
| PST-50AT | PVT-770RT | |

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) into elabor regulations affecting your device can be may be subject to such additions, Title 2, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register

furnier announcenting concerning your as not the the the the mination does not mean that Flease be advised mat 1 271 's issualled of a eveemonomies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all r cocration and regulations administed to: registration and listing (21 CFR Part 807); the Act s requirements, merading, but notacturing practice requirements as set forth in the quality labeling (21 CFR Part 007), good manazive; 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 The I DA midnig of substantial equivice 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 If you desire specific ad roo for your and additionally, for questions on the promotion comact the Office of Compines at [phone] Compliance at [phone]. Also, and advertising of your deviles, prease vehicles by reference to premarket notification" (21 CFR picase note in regulation on the responsibilities under the Act may be obtained from I at 801:27). Other general Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

David An. Lynn

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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System _X__ Transducer____ SSA-770A______________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

| | | | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|------------|-----------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | 1.5<br>RSI | TDI-<br>Q |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | 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 | | | |
| Small Organ (Specify)*** | P | P | P | | P | P | P | 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 | E' | P | P |
| Transesophageal | P | P | P | P | P | P | P | P | | E' | | P |
| Transrectal | P | P | P | | P | P | P | P | P | | | |
| Transvaginal | P | P | P | | P | P | P | P | P | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | | | |
| Laparoscopic | P | P | P | | P | P | P | P | | | | |
| Musculo-skeletal | P | P | P | | P | P | P | P | P | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | | P | P | P | P | P | | | |

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

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

| E'-- Added via LTF against SSA-700A 510(k) control number K022400 |
|-------------------------------------------------------------------|
| Previous 510(k) for this device k013633 |
| ** Abdominal |
| *** For example: thyroid, parathyroid, breast, scrotum and penis |

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

Jamilah Begum

(Division Sign Division of Re and Radio 510(k) Numbe

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Transducer_X__ System __ PST-25AT_ Model_ 510(k) Number(s)

| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | 1.5<br>RSI | TDI-Q |
|----------------------------------|---|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|------------|-------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P | E¹ | | P |
| Cardiac | 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: Additional Continution ContinuedPWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF

E' - Added via LTF against SSA-700A 510(k) control number K022400 Previous 510(k) for this device k013633

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

Daniel Ch. Sayre

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

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

Transducer X System __ PVT-375AT Model_ 510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|-------------|-----------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | ાં ર<br>RSI | TDI-<br>Q |
| 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<br>Conventional | | | | | | | | | | | | |

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

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

Previous 510(k) for this device k013633

(PI.E.A.SE DO NOT WRITE BELOW THIS LINE · CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Seryson

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

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

Transducer X System _______________________________________________________________________________________________________________________________________________________________________ PVT-661 VT Model_ 510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|--------------------------------|-------------------|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|------------|-------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | 1.5<br>RSI | TDI-Q |
| 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 | | | | | | | | | | | | |
| 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: Auditional Comments:
BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device k013633

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

David R. Ingram

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

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

Transducer _X System _ PLT-805AT Model_ 510(k) Number(s)

| | | | | | | | | Mode of Operation | | | | | |
|-------------------------------|---|---|-------|-------|---------------|-------------------|------------------------|--------------------|------------------|--------------|---------|--------|--|
| Clinical Application | B | M | P W D | C W D | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | 1.5 Harmonic | 1.5 RSI | TDI- Q | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) | P | 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 | P | P | P | | P | P | P | P | P | | | | |
| Superficial | | | | | | | | | | | | | |
| Musculo-skeletal 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: Additional Commonts: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device k013633

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

Daniel Ch. Johnson

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices : 10(k) Number _______________________________________________________________________________________________________________________________________________________________

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

Transducer _X System _ PST-20CT______________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|------------|-----------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | 1.5<br>RSI | TDI-<br>Q |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P | P | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | 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; FEV2D; CHI/BDF; FEVBDF

Previous 510(k) for this device k013633

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

Daniel k. Leyman

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

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

Transducer_X System __ PLT-1204AX____________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

| Mode of Operation | | | | | | | | | | | | |
|----------------------------------|---|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|------------|-------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | 1.5<br>RSI | TDI-Q |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| 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: Additional Continents: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device k013633

(PLEASE DO NOT WRITE BELOW THIS LINE / CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRII, Office of Device Eyaluation (ODE)

David A. Syverson

(Division Sign-Off) (Division of Reproductive, Abdo and Radiological Devices 51()(k) Number _______________________________________________________________________________________________________________________________________________________________

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

Transducer X System __ PC-20M Model_ 510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|------------|-----------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | 1.5<br>RSI | TDI-<br>Q |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | P | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skelctal | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |

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

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

Previous 510(k) for this device k013633

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

David A. Lyman

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

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

Transducer X System __ PET-510MB Model_ 510(k) Number(s)

| Mode of Operation | | | | | | | | | | | | |
|----------------------------------|---|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|------------|-----------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | 1.5<br>RSI | TDI-<br>Q |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | E | | P |
| Transesophageal | P | P | P | P | P | P | P | P | P | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |

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

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

Previous 510(k) for this device k013633

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

David M. Segeen

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

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

Transducer_X System __ PLT-1202S Model_ 510(k) Number(s)

| Mode of Operation | | | | | | | | | | | | |
|-------------------------------|---|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|-----------------|------------|-------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>Harmonic | 1.5<br>RSI | TDI-Q |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | P | P | P | | P | P | P | P | P | | | |
| Intraoperative 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 Superficial | P | P | P | | P | P | P | P | P | | | |
| Musculo-skeletal 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: Additional Comments:
BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHV2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device k013633

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

David A. Egerom

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

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

Transducer _X System _ PET-704LA_ Model_

510(k) Number(s)

| Clinical Application | B | M | P W D | C W D | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | 1.5 Harmonic | 1.5 RSI | TDI-Q |
|-------------------------------|---|---|-------|-------|---------------|-------------------|------------------------|--------------------|------------------|--------------|---------|-------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | | P | P | | | | |
| 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: Additional Continuer; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device k013633

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

David A. Legerm

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

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

Transducer _X System _______________________________________________________________________________________________________________________________________________________________________ PST-37CT_ Model_ 510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | |
|--------------------------------|-------------------|---|-------------|-------------|------------------|----------------------|------------------------------|-----------------------|---------------------|------------|------------|-------|
| Clinical Application | B | M | P<br>W<br>D | C<br>W<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | 1.5<br>THI | 1.5<br>RSI | TDI-Q |
| Ophthalmic | | | | | | | | | E | | | |
| Fetal | E | E | E | E | E | E | E | E | E | | | |
| Abdominal | E | E | E | E | E | E | E | E | E | | | |
| Intraoperative (Specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | E | E | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |…