ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM

K983879 · Aloka Co., Ltd. · IYO · Mar 22, 1999 · Radiology

Device Facts

• Record ID: K983879
• Device Name: ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Aloka Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Aloka SSD-900, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.

Device Story

Aloka SSD-900 is a diagnostic ultrasound system using piezo-electric transducers to transmit high-frequency sound waves into the body. Differences in acoustic impedance of tissues reflect energy back to the transducer, which is processed into gray-scale slice images. Used in clinical settings by healthcare professionals for diagnostic imaging of various body structures. Output is displayed as gray-scale images (B-mode, M-mode, B/M combined) to aid in disease or abnormality diagnosis. System performance and safety are maintained through standard quality assurance and electrical safety compliance.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological characteristics, acoustic output measurements, and compliance with safety standards.

Technological Characteristics

Diagnostic ultrasound system with gray-scale imaging. Uses piezo-electric transducers. Operates in A, B, M, and combined B/M modes. Complies with electrical and physical safety standards. Patient contact materials evaluated for safety. Acoustic power output levels are below FDA maximums.

Indications for Use

Indicated for diagnostic ultrasound imaging of the human body, including fetal, abdominal, intra-operative, intra-operative neurological, pediatric, small organ (breast, testes, thyroid), neonatal cephalic, adult cephalic, cardiac adult, cardiac pediatric, transrectal, transvaginal, musculo-skeletal conventional, peripheral vessel, and laparoscopic 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

• Aloka SSD-1400

Submission Summary (Full Text)

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

3/22/99

K983879

### 510(k) SUMMARY

This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.

This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-900 diagnostic ultrasound system. The address is:

10 Fairfield Boulevard Wallingford, CT. 06492

The contact person is Paul D. Smolenski, Manager, Quality and Regulatory Affairs.

The proprietary name for the transducer is the Aloka SSD-900 diagnostic ultrasound system. The common name for this type of device is a diagnostic ultrasound system and associated accessories.

The items in this submission are covered under the following classifications:

90 ITX - Transducer, Ultrasonic, Diagnostic 90 IYO - Ultrasonic Pulsed Echo Imaging System and Accessories

The above as stated in 21 CFR, part 892.1570, and 892.1560 have been classified as regulatory Class II.

The Aloka SSD-900 is substantially equivalent to several previously marketed diagnostic ultrasound systems such as the Aloka SSD-1400.

The SSD-900 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into slice images.

The SSD-900, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.

The Aloka SSD-900 diagnostic ultrasound system with gray-scale imaging modalities is similar in technological characteristics to ultrasound systems marketed by Aloka and others:

- The SSD-900 is indicated for the same diagnostic ultrasound applications as other . products currently marketed by Aloka and others.

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

- The SSD-900 has the same gray-scale abilities as other products currently offered by . Aloka and others.
- The SSD-900 uses essentially the same technologies for imaging and signal processing . as other products currently marketed by Aloka and others.
- The SSD-900 has the same method of use as other products currently marketed by . Aloka and others.
- The SSD-900 acoustic power output levels are below the maximum levels allowed by . the FDA.
- The SSD-900 is subjected to the same Quality Assurance systems in development and . production as other products currently marketed by Aloka.
- The patient contact materials used in the probes for the SSD-900 have been evaluated . and found to be safe for this application.
- The SSD-900 complies with the same electrical and physical safety standards as other . products currently marketed by Aloka.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

Public Health Service

#### MAR 2 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shoichi Nakai General Manager Aloka Co., Ltd. 10 Fairfield Boulevard Wallingford, CT 06492-7502

Re: K983879

Aloka SSD-900 Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1560/21 CFR 892.1570 Product Code: 90 IYO/90 ITX Dated: February 1, 1999 Received: February 2, 1999

Dear Mr. Nakai:

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 Aloka SSD-900 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

| ASU-35WL-10 | ASU-36WL-10 | ASU-35-3 | ASU-66 | ASU-64 |
|--------------|--------------|--------------|-------------|-------------|
| UST-5524-7.5 | UST-5536-7.5 | UST-579T-7.5 | UST-670P-5 | UST-670P-5 |
| UST-979-3.5 | UST-984P-5 | UST-987-7.5 | UST-9116P-5 | UST-995-7.5 |

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 QS 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.

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 investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 이상 인물

> > 14.81 - 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1.

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

#### Page 2 - Shoichi Nakai

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

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

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

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to 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 Paul Gammell, Ph.D. at [phone].

Sincerely vours.

David A. Seymore

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

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

K 983879

510(k) Number (if known): Device Name:

..............................................................................................................................................................................

unknown at submission Aloka SSD-900 Diagnostic Ultrasound System

### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|-----|----------|-------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | ✓ | ✓ | | | | | | B/M | |
| Abdominal | ✓ | ✓ | ✓ | | | | | | B/M | |
| Intra-Operative | | ✓ | ✓ | | | | | | B/M | |
| Intra-Operative<br>Neurological | | ✓ | ✓ | | | | | | B/M | |
| Pediatric | | ✓ | ✓ | | | | | | B/M | |
| Small Organ | | ✓ | ✓ | | | | | | B/M | |
| Neonatal Cephalic | | ✓ | ✓ | | | | | | B/M | |
| Adult Cephalic | | ✓ | ✓ | | | | | | B/M | |
| Cardiac Adult | | ✓ | ✓ | | | | | | B/M | |
| Cardiac Pediatric | | ✓ | ✓ | | | | | | B/M | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | ✓ | ✓ | | | | | | B/M | |
| Transvaginal | | ✓ | ✓ | | | | | | B/M | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | ✓ | ✓ | | | | | | B/M | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | ✓ | ✓ | | | | | | B/M | |
| Laparoscopic | | ✓ | ✓ | | | | | | B/M | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (O

Prescription Use (Per 21 CFR 801.109)

David li. Begom

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

Page 1 of 16

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

963879

Page 2 of 16

## Ultrasound Device Indications Statement

510(k) Number (if known): Device Name:

:

unknown at submission ASU-35WL-10

### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | | |
|-------------------|--------------------|--------------|--------------|-----|-----|---------|-----------|-----|----------|-------|--|
| Clinical | A | B | M | PWD | CWD | Color | Amplitude | CVI | Combined | Other | |
| Application | | | | | | Doppler | Doppler | | | | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | <div>✓</div> | <div>✓</div> | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| fransrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Intraluminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

Other Indications or Modes:

Small Organ Applications:

Breast, Testes, Thyroid

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

David L. Siegmann
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number

Prescription Use (Per 21 CFR 801.109)

21

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

# K983879

#### Ultrasound Device Indications Statement

Page 3 of 16

510(k) Number (if known): Device Name:

unknown at submission ASU-36WL-10

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | |
|----------------------|--------------------|---|---|-----|-----|---------------|-------------------|-----|----------|-------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | ✓ | ✓ | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| ransrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal | | ✓ | ✓ | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

Small Organ Applications:

Breast, Testes, Thyroid

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)

Ehrich G. Segism
(Division Sign-Off)

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

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

K953879

Page 4 of 16

unknown at submission 510(k) Number (if known): ASU-35-3 Device Name:

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | |
|-------------------|--------------------|---|---|-----|-----|---------|-----------|-----|----------|-------|
| Clinical | A | B | M | PWD | CWD | Color | Amplitude | CVI | Combined | Other |
| Application | | | | | | Doppler | Doppler | | | |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | ✓ | ✓ | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | ✓ | ✓ | | | | | | | |
| Cardiac Pediatric | | ✓ | ✓ | | | | | | | |
| Transesophageal | | | | | | | | | | |
| ransrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

Small Parts: Breast, Testes, Thyroid

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

David C. Lygum
(Division Sign-Off)

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

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

K953879

Page 5 of 16

510(k) Number (if known): ASU-66 Device Name:

unknown at submission

### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | | |
|-------------------------|--------------------|---|---|-----|-----|------------------|----------------------|-----|----------|-------|--|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | ✓ | ✓ | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| transrectal | | | | | | | | | | | |
| Transvaginal | | ✓ | ✓ | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Intraluminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Vinit C. Segmm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

- ..

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

K9653879

Page 6 of 16

unknown at submission 510(k) Number (if known): Device Name: ASU-64

Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | |
|----------------------|--------------------|---|---|-----|-----|---------------|-------------------|-----|----------|-------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | ✓ | | | | | | | |
| Transrectal | | | ✓ | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Elnit G. Sealing

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

Prescription Use (Per 21 CFR 801.109)

.

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

K983879

Page 7 of 16

510(k) Number (if known): Device Name:

unknown at submission UST-5524-7.5

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | | |
|-------------------------------|--------------------|---|---|-----|-----|---------------|-------------------|-----|----------|-------|--|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | ✓ | ✓ | | | | | | B/M | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| fransrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Musculo-Skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Intraluminal | | | | | | | | | | | |
| Peripheral Vessel | | ✓ | ✓ | | | | | | B/M | | |
| Laparoscopic | | | | | | | | | | | |

Other Indications or Modes:

Small Organ Applications:

Breast, Testes, Thyroid

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)

Emil C. Hegmann

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

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

K963879

510(k) Number (if known): unknown at submission UST-5536-7.5 Transducer Device Name:

Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|-----|----------|-------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | ✓ | ✓ | | | | | | | | |
| Laparoscopic | | ✓ | ✓ | | | | | | B/M | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Gland G. Siggm

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

Prescription Use (Per 21 CFR 801.109)

Page 8 of 16

1

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

K9835879

Page 9 of 16

510(k) Number (if known): unknown at submission UST-579T-7.5 Device Name:

ﺴﻌﻴﺪ

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | |
|------------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----|-----|---------------|-------------------|-----|----------|-------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | <div> <svg height="10" width="10"> <path d="M0 0 L10 10 M10 0 L0 10" stroke="black" stroke-width="2"></path> </svg> </div> | <div> <svg height="10" width="10"> <path d="M0 0 L10 10 M10 0 L0 10" stroke="black" stroke-width="2"></path> </svg> </div> | | | | | | B/M | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | <div> <svg height="10" width="10"> <path d="M0 0 L10 10 M10 0 L0 10" stroke="black" stroke-width="2"></path> </svg> </div> | <div> <svg height="10" width="10"> <path d="M0 0 L10 10 M10 0 L0 10" stroke="black" stroke-width="2"></path> </svg> </div> | | | | | | B/M | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal/transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | <div> <svg height="10" width="10"> <path d="M0 0 L10 10 M10 0 L0 10" stroke="black" stroke-width="2"></path> </svg> </div> | <div> <svg height="10" width="10"> <path d="M0 0 L10 10 M10 0 L0 10" stroke="black" stroke-width="2"></path> </svg> </div> | | | | | | B/M | |
| Laparoscopic | | | | | | | | | | |

Combined Modes: B/M, B/PWD Other Indications or Modes:

Intraoperative Applications: Small Organ Applications:

Abdominal (such as liver, pancreas, gall bladder) Breast, Testes, Thyroid

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Ehrid C. Szyrm
(Division Sign-Off)

(Production Sigli-Off)
Division of Reproductive, Abdominal, EN and Radiological Reproduct
and Radiological Devi

Surgical Devices
510(k) Number K98387

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

K9833879

Page 10 of 16

510(k) Number (if known): Device Name:

unknown at submission UST-672-5/7.5

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | | MODES of OPERATION | | | | | | | | | |
|-------------------------|---|--------------------|---|-----|-----|------------------|----------------------|-----|----------|-------|--|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other | |
| | | | | | | | | | | | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | ✓ | ✓ | | | | | | B/M | | |
| Intra-Operative | | ✓ | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| 'ransrectal | | ✓ | ✓ | | | | | | B/M | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Intraluminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

Other Indications or Modes:

Intraoperative Applications:

Abdominal (such as liver, pancreas, gall bladder)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Uminh C. Nguyen
(Division Sign-Off)

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

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

K963879

510(k) Number (if known): Device Name:

unknown at submission UST-670P-5

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| Clinical Application | MODES of OPERATION | | | | | | | | | |
|------------------------------|--------------------|---|---|-----|-----|---------------|-------------------|-----|----------|-------|
| | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | CVI | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | ✓ | ✓ | | | | | | B/M | |
| Transvaginal | | ✓ | ✓ | | | | | | B/M | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Laind L. Pearson

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

rescription Use (Per 21 CFR 801.109)

t

Page 11 of 16

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

K983879

Page 12 of 16

510(k) Number (if known): unknown at submission UST-979-3.5 Device Name:

-

#### Fill our one form for each ultrasound system and transducer

Indications for Use: Diagnostic Ultrasound imaging of the human body as follows:

| | MODES of OPERATION | | | | | | | | | |
|-------------------|--------------------|---|---|-----|-----|---------|-----------|-----|----------|-------|
| Clinical | A | B | M | PWD | CWD | Color | Amplitude | CVI | Combined | Other |
| Application | | | | | | Doppler | Doppler | | | |
| Opthalmic | | | | | | | | | | |
| Fetal | | > | > | | | | | | B/M | |
| Abdominal | | > | V | | | | | | BM | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | > | > | | | | | | B/M | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| ransrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

David A. Watson

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

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

K963879

Page 13 of 16

510(k) Number (if known): unknown at submission UST-984P-5 Device Name:

्

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| MODES of OPERATION | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|-----|----------|-------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | ✓ | ✓ | | | | | | B/M | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal<br>ransrectal | | | | | | | | | | |
| Transvaginal | | ✓ | ✓ | | | | | | B/M | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Daniel A. Segerson

ive, Abdominal,

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

K983879

Page 14 of 16

510(k) Number (if known): unknown at submission UST-987-7.5 Device Name:

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | | |
|-----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|-----|----------|-------|--|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-Operative | | ✓ | ✓ | | | | | | B/M | | |
| Intra-Operative<br>Neurological | | ✓ | ✓ | | | | | | B/M | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | ✓ | ✓ | | | | | | B/M | | |
| Neonatal Cephalic | | ✓ | ✓ | | | | | | B/M | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Intraluminal | | | | | | | | | | | |
| Peripheral Vessel<br>Laparoscopic | | | | | | | | | | | |

Other Indications or Modes:

Intraoperative Applications: Small Organ Applications:

Neurological, Abdominal (such as liver, pancreas, gall bladder) Breast, Testes, Thyroid

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Øffice of Device Evaluatition (ODE)

Yamil h. Nayam

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

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

K983879

Page 15 of 16

510(k) Number (if known): Device Name:

ﮯ ﺳﯿﺮﺱ

unknown at submission UST-9116P-5

#### Fill our one form for each ultrasound system and transducer

Indications for Use: Diagnostic Ultrasound imaging of the human body as follows:

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other |
|---------------------------------|---|---|---|-----|-----|------------------|----------------------|-----|----------|-------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | ✓ | ✓ | | | | | | B/M | |
| Intra-Operative | | ✓ | ✓ | | | | | | B/M | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)

Simil C. Lezman

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

510(k) Number K983879

{19}------------------------------------------------

K983879

Page 16 of 16

510(k) Number (if known): unknown at submission UST-995-7.5 Device Name:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

#### Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging of the human body as follows: Indications for Use:

| | MODES of OPERATION | | | | | | | | | | |
|-------------------------|--------------------|---|----------------------------------------|-----|-----|------------------|----------------------|-----|----------|-------|--|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | <div> <div> <div> </div> </div> </div> | | | | | | | | |
| Intra-Operative | | ✓ | ✓ | | | | | | B/M | | |
| Intra-Operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Intraluminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

Combined Modes: B/M,B/PWD Other Indications or Modes:

Intraoperative Applications:

Abdominal (such as liver, pancreas, gall bladder)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)

Clint C. Sazom

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