SSA-370A/POWERVISION 6000

K991710 · Toshiba America Medical Systems, In.C · IYO · Jun 3, 1999 · Radiology

Device Facts

• Record ID: K991710
• Device Name: SSA-370A/POWERVISION 6000
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: IYO · Radiology
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Power Vision 6000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).

Device Story

PowerVision 6000 is a mobile diagnostic ultrasound system. It utilizes various probes (flat linear, convex linear, sector) operating in 2-10 MHz range. System captures acoustic echoes/Doppler signals; processes data to generate B-mode, M-mode, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, and Harmonic Imaging outputs. Operated by clinicians in clinical settings. Output displayed on monitor for real-time visualization of anatomy and blood flow; assists in diagnostic decision-making across multiple clinical specialties. System design adheres to IEC-60601 and AIUM-NEMA UD2/UD3 standards for safety and output measurement.

Clinical Evidence

Bench testing only. Device safety and effectiveness supported by compliance with IEC-60601, AIUM-NEMA UD2 (Output Measurement Standard for Track 3 systems), and AIUM-NEMA UD3 (Output Display Standard). No clinical data presented.

Technological Characteristics

Mobile ultrasound system; Track 3 device. Probes: flat linear, convex linear, sector arrays (2-10 MHz). Modes: B, M, PWD, CWD, Color/Amplitude Doppler, Color Velocity, Harmonic Imaging. Standards: IEC-60601, AIUM-NEMA UD2, AIUM-NEMA UD3. Quality System Regulation (21 CFR Part 820) compliant.

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 applications. Contraindicated for in vitro fertilization and percutaneous umbilical blood sampling.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• SSA-380A/PowerVision 7000 (K933743, K943303, K963705, K964865, K970047, K981397)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '991710'. The numbers are written in a simple, clear style, making them easily readable.

#### 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92 JUN 3 1999

| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|-------------------|---------------------------------------------------------|
| Address: | P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Paul Biggins, Regulatory Affairs Specialist |
| Telephone No.: | [phone] |

Device Proprietary Name: SSA-370A/PowerVision 6000 Common Name: Ultrasound Imaging System

## Classification:

Regulatory Class: II Review Category: Tier II

Ultrasonic Pulsed Doppler Imaging System - Procode: 90-IYN [Fed.Reg.No .: 892.1550] Ultrasonic Pulsed Echo Imaging System - Procode: 90-IYO [Fed.Reg.No.:892.1560] Diagnostic Ultrasonic Transducer - Procode: 90-ITX [Fed. Reg. No.: 892.1570]

## Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964865,K970047,K981397

## Device Description:

The PowerVision 6000 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 10 MHz.

## Intended Use:

The Power Vision 6000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, 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 (applicable portions), the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard. This unit is similar to that of the Toshiba SSA-380A/PowerVision 7000 and engineering assessments identify no new issues of risk or safety.

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

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left and "USA" on the right.

JUN 3 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toshiba America Medical Systems c/o Carole Stamp TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K991710 Trade Name: SSA-370A PowerVision 6000 Regulatory Class: 892.1560, 892.1560, 892.1570 Product Code: 90-IYO, 90-IYN, 90-ITX Classification: II Dated: May 18, 1999 May 19, 1999 Received:

Dear Ms. Stamp:

We have reviewed your Section 510(k) 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, Druq, 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 SSA-370A PowerVision 6000 as described in your premarket notification:

#### Transducer Model Numbers

PLM-703AT, PLM-503AT, PLM-805AT, PC-19M, PLF-308P, PSM-20CT, PSM-25AT, PSM-37AT, PSM-50AT, PSM-37CT, PVF-738F, PVF-738H, PVM-662AT, PEF-510MB, PVM-621VT, PVM-375AT, PVF-620ST.

If your device is classified (see above) into either class II (Special Controls) or class III (Pre-market Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 Therefore, your product labeling must be consistent with FDA's CFR, Part 812. position on this use.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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 Robert Phillips, Ph.D. at [phone].

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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

## Diagnostic Ultrasound Indications For Use Form

Transducer____________________________________________________________________________________________________________________________________________________________________ System_X_ Model_________________________________________________________________________________________________________________________________________________________________________

. i

510(k) Number(s) _

ﺮ ﺍ

| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | n | n | n | n | n | n | n | n | n |
| Abdominal | | n | n | n | n | n | n | n | n | n |
| Intraoperative (Specify) | | n | n | n | | n | n | n | n | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | n | n | n | n | n | n | n | n | n |
| Small Organ (Specify) | | n | n | n | | n | n | n | n | |
| Neonatal Cephalic | | n | n | n | n | n | n | n | n | |
| Adult Cephalic | | n | n | n | n | n | n | n | n | |
| Cardiac | | n | n | n | n | n | n | n | n | n |
| Transesophageal | | n | n | n | n | n | n | n | n | |
| Transrectal | | n | n | n | | n | n | n | n | |
| Transvaginal | | n | n | n | | n | n | n | n | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | n | n | n | | n | n | n | n | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | n | n | n | | n | n | n | n | |
| Musculo-skeletal | | n | n | n | | n | n | n | n | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number . Prescription Use (Per 21 CFR 801.109)

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

Transducer Model Number: PVF-620ST 510(k) Control Number: K964865

| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|------------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | P | P | |
| Transvaginal | | P | P | P | | P | P | P | P | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

NOTE: Original model number was PVK-720ST

. i

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

---

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

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K991710

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

#### Transducer Model Number: PVM-375AT 510(k) Control Number: K943303

| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|------------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
| 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 | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |

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

Color Harmonic Imaging is applied to BDF and BDF/PWD modes NOTE: Original model number was PVK-357AT

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

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

Radiological Devices
510(k) Number K991710

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

### NEW TRANSDUCER TABLE

Transducer Model Number: PVM-621VT 510(k) Control Number:

| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | N | N | N | | N | N | N | N | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

> IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON O Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

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

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

## EXISTING TRANSDUCER TABLE Transducer Model Number: PEF-510MB 510(k) Control Number: K964865

| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative 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 | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

NOTE: Original model number was PEF-511SA (K890969)

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

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

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

## NEW TRANSDUCER TABLE

Transducer Model Number: PVM-662AT 510(k) Control Number:

| | | Mode of Operation | | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | N | N | N | N | | N | N | N | N | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | | N | N | N | N | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

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

---

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K991710

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

#### Transducer Model Number: PVF-738H 510(k) Control Number: K990490

ﺎﻣﻴﺔ، ﺇ

| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | P | P | |
| Intraoperative (Specify) | | P | P | P | | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | P | P | P | | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

NOTE: Original model number was IOE-703H (K852159)

. :

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

Signature

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

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

#### Transducer Model Number: PVF-738F 510(k) Control Number: K990490

| | | | | | | Mode of Operation | | | | |
|------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | P | P | |
| Intraoperative (Specify) | | P | P | P | | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | P | P | P | | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |

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

NOTE: Original model number was IOE-703F (K852159)

. i

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

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

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

### Transducer Model Number: PSM-37CT 510(k) Control Number: K933743

| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | E | E | E | E | E | E |
| Abdominal | | E | E | E | E | E | E | E | E | E |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | E | E | E | E | E | E | E | E | E |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

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

NOTE: Original model number was PSK-37CT

(PLEASE DO NOT WRITTS BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) . i (Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

് 10(k) Number _

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

Transducer Model Number: PSM-50AT 510(k) Control Number: K933743

Mode of Operation PWD B M CWD Color Amplitude Color Combined Other A Clinical Application (Specify) Doppler (Specify) Doppler Velocity Imaging Ophthalmic Fetal Abdominal Intraoperative (Specify) Intraoperative Neurological E Pediatric E E E E E E E Small Organ (Specify) Neonatal Cephalic E E E E E E E E Adult Cephalic Cardiac E E E E E E E E Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral Vascular Laparoscopic Musculo-skeletal Superficial Musculo-skeletal Conventional Other (specify) 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

NOTE: Original model number was PSK-50LT

. :

DI EASE DA NOT WATTE RELOW THIS LINE CONTINUE ONLOTHER DAGES IS NE Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K991710

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

## Transducer Model Number: PSM-37AT 510(k) Control Number: K933743

ﺴﻴ

......

: 、

| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|------------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | E | E | E | E | E | E | E | E | E |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | E | E | E | E | E | E |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | E | E | E | E | E | E | E | E | E |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

NOTE: Original model number was PSK-37AT

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

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

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K991710 |
|---------------|---------|
|---------------|---------|

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

Transducer Model Number: PSM-25AT 510(k) Control Number: K933743

| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | P | P | P |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | P | P | P |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

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

Color Harmonic Imaging is applied to BDF and BDF/PWD modes

NOTE: Original model number was PSK-25AT

. i

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

Division Sign Off

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

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

## Transducer Model Number: PSM-20CT 510(k) Control Number: K970047

ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | P | P | |
| Adult Cephalic | | P | P | P | P | P | P | P | P | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |

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

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

NOTE: Original model number was PSK-20CT

. i

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

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

510(k) Number -

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

Transducer Model Number: PLF-308P 510(k) Control Number: K852159

| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | P | P | |
| Intraoperative (Specify) | | P | P | P | | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | 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 | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |

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

NOTE: Original model number was GCE-406M

. :

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

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

510(k) Number .

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

.

## Transducer Model Number: PC-19M 510(k) Control Number: K933473

ﺎ

... .

| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (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 | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | |…