SSA-320A JUST VISION 200/ SSA-325A JUST VISION

K990490 · Toshiba America Medical Systems, In.C · IYO · Mar 2, 1999 · Radiology

Device Facts

• Record ID: K990490
• Device Name: SSA-320A JUST VISION 200/ SSA-325A JUST VISION
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: IYO · Radiology
• Decision Date: Mar 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

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

Device Story

JustVision 200/400 are compact portable or mobile ultrasound imaging systems; 12-inch monitor. Employs wide array of probes (flat/convex linear); frequency range 2-10 MHz. Operates in B-mode and M-mode (including B+M combined). Used by clinicians for diagnostic imaging in various clinical settings. System transforms ultrasonic pulsed echo signals into visual images for diagnostic assessment. Healthcare providers interpret images to support clinical decision-making across multiple anatomical regions. Benefits include non-invasive diagnostic visualization of internal structures.

Clinical Evidence

Bench testing only. Compliance with ISO-60601 and AIUM-NEMA UD2 Output Measurement Standard for Track 1 systems. No clinical data presented.

Technological Characteristics

Track 1 ultrasonic pulsed echo imaging system. Frequency range 2-10 MHz. Probes: flat linear and convex linear arrays. 12-inch monitor. Compliance with ISO-60601 and AIUM-NEMA UD2 standards. Connectivity: standalone/mobile. Sterilization: per manufacturer guidelines for transducers.

Indications for Use

Indicated for fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculo-skeletal (conventional/superficial) ultrasound imaging.

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-220A Capasee (K933747)

Reference Devices

• SSA-140A (K913798)
• SSA-90A (K852159)

Submission Summary (Full Text)

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

3/2/99

q90490

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

| 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] |

Just Vision 200 and Just Vision 400 Device Proprietary Name: Common Name: Ultrasound Imaging System

### Classification:

Regulatory Class: II Review Category: Tier II Ultrasonic Pulsed Echo Imaging System [Fed.Reg.No .: 892.1560,Pro.Code:90-IYO]

#### Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-220A Capasee, 510(k) control number K933747

#### Device Description:

The JustVision Ultrasound System is available as a compact portable system or can be configured as a mobile system with a 12 inch monitor. This system is a Track 1 device that employs a wide array of probes that include flat linear array and convex linear array, with a frequency range of approximately 2 MHz to 10 MHz.

#### Intended Use:

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

#### Safety Considerations:

This device is designed and manufactured in conjunction with the Quality System Regulation, ISO- 60601 (applicable portions) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 1 Ultrasound systems. This unit is similar to that of the Toshiba SSA-220A Capasee and engineering assessments identify no new issues of risk or safety.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that features three stylized human figures, possibly representing people, in a flowing, abstract design.

MAR - 2 1999

Toshiba America Medical Systems, Inc. C/o Carole Stamp TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

K990490 Re: SSA-320A JustVision 200 and SSA-325A JustVision 400 Regulatory Class: II/ 21 CFR 892.1560/21 CFR 892.1570 Product Code: 90 IYO/ 90 ITX Dated: February 11, 1999 Received: February 16, 1999

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, 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 SSA-320A JustVision 200 and SSA-325A JustVision 400, as described in your premarket notification:

> Transducer Model Number PVG-366M PVG-381M PVG-681S PVG-600S PVG-601V PVG-720S PVG-738F PVF-738H PVF-745V PLG-308P PLG-506M

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 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 (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic OS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation 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}------------------------------------------------

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. 1. 1. 1. 1. 1. 18. 1. 18. 1. 1. 1. 1. 1. 1. 1. 1.

有限公司 > 上一篇: 上一篇:

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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Robert A. Phillips, Ph.D. at [phone].

Sincerely vours.

Kamil A. Seymann

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

Enclosures

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

Transducer_ System _X__ Model____SSA -320A/SSA-325A_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s) _____________________________________________________________________________________________________________________________________________________________

| | | 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 | | n | n | | | | | | n | |
| Abdominal | | n | n | | | | | | n | |
| Intraoperative (Specify) | | n | n | | | | | | n | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | n | n | | | | | | n | |
| Small Organ (Specify) | | n | n | | | | | | n | |
| Neonatal Cephalic | | n | n | | | | | | n | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | n | n | | | | | | n | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | n | n | | | | | | n | |
| Transvaginal | | n | n | | | | | | n | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | n | n | | | | | | n | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | n | n | | | | | | n | |
| Musculo-skeletal<br>Conventional | | n | n | | | | | | n | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: _________________________________________________________________________________________________________________________________________________________

and the comments of the comments of the comments of the comments of the comments of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER CCC IS NEDDED --Concyfrence of CDRH, Office of Device Evaluation (ODE)

David A. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

Radiological Devices
510(k) Number K990490

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

Transducer_x__ System PVG-366M Model_ 510(k) Number(s) _

| | | 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 | | P | P | | | | | | P | | |
| Abdominal | | P | P | | | | | | P | | |
| Intraoperative (Specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| 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 mode is B+M

Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747

Concerrence of CDRH. Office of Device Evaluatio

David G. Severson

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

Prescription Use (Per 21 CFR 801.109)

2

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

Transducer_x System ___ PVG-381M_ Model 510(k) Number(s) _

| | | 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 | | P | P | | | | | | P | | |
| Abdominal | | P | P | | | | | | P | | |
| Intraoperative (Specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | 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)

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747

Concurrence of CDRH. Office of Device Evalua

David A. Syzmon

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

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

Transducer_X System _ Model_ PVG-681S_ 510(k) Number(s) __

| | 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 | | N | N | | | | | | N | | |
| Intraoperative (Specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | N | N | | | | | | N | | |
| 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 mode is B+M

Device Evaluat

Uhmil A. Syonn
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

4

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

System _ Transducer_X__ PVG-600S Model

510(k) Number(s) __

| | | | 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 | | N | N | | | | | | N | | |
| 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 mode is B+M

Note: This transducer was originally cleared with the SSA-140A via 510(k) control number

K913798

Concurrence of CDRH. Office of Device Evaluatio

David A. Seznor
(Division Sign Off)

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

510(k) Number K140440

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

Transducer_X_ System _ PVG-601V Model 510(k) Number(s) _

| | | 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 | | P | P | | | | | | P | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | 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 mode is B+M

Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747

> 4PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PA Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Tegner

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

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

System _ Transducer_X_ -PVG-720S Model_ 510(k) Number(s) _

| | | 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 | | P | P | | | | | | P | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | N | N | | | | | | N | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | N | N | | | | | | N | |
| Musculo-skeletal | | P | P | | | | | | P | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared with the SSA-220A via 510(k) control number

K933747

Concurrence of CDRH, Office of Device Evaluatio

David G. Segner

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

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

Transducer_X System PVF-738F Model ______________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s) _____________________________________________________________________________________________________________________________________________________________

| | | 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 | |
| Intraoperative (Specify) | | P | P | | | | | | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | P | P | | | | | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | | | | | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | N | N | | | | | | N | |
| Musculo-skeletal | | N | N | | | | | | N | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared as probe IOE-703F with the SSA-90A via 510(k) control number K852159

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

Concurrence of CDRH, Office of Device Evaluation (C

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990490

Prescription Use (Per 21 CFR 801.109)

8

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

System __ Transducer_X_ PVF-738H_ Model ______________________________________________________________________________________________________________________________________________________________________________

510(k) Number(s) __

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

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

#### Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared as probe IOE-703H with the SSA-90A via 510(k) control number K852159

> (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER DALES IN NECKED Concurrence of CDRH, Office of Device Evaluation (ODE)

Clint G. Seppam

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devic

510(k) Number K992446

9

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

System __ __ Transducer_X_ Model_ PVF-745V 510(k) Number(s) _

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

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

Additional Comments: Combined mode is B+M

Note: This transducer was originally cleared as probe IOE-703F with the SSA-90A via 510(k) control number K852159

Concurrence of CDR

David G. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Devi

510(k) Number K990445

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

Transducer_X_ System _ Model_ PLG-308P 510(k) Number(s) _

| | | 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 | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| 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 mode is B+M

Note: This transducer was originally cleared as probe GCE-406M With the SSA-90A via 510(k)

| control number | K852159 |
|----------------|---------|
|----------------|---------|

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE Concurrence of CDRH, Office of Device Evaluation

David A. Sezmann

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

510(k) Number K990440

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

Transducer_X_ System _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PLG-506M Model_ 510(k) Number(s) _

| | | 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) | | | N | N | | | | | | N | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | N | N | | | | | | N | |
| Musculo-skeletal | | | N | N | | | | | | N | |
| Conventional | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

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

Additional Comments: Combined mode is B+M

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

David G. Segerson

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