ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM

K972465 · Aloka Co., Ltd. · IYN · Aug 15, 1997 · Radiology

Device Facts

• Record ID: K972465
• Device Name: ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Aloka Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Aloka SSD-1400, 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-1400 is a diagnostic ultrasound system using piezo-electric transducers to transmit high-frequency sound waves into the body. The system detects reflected sound waves based on tissue acoustic impedance differences to generate images; it also utilizes Doppler shift to detect and display blood flow. Operated by clinicians in clinical settings, the device provides gray-scale and Doppler imaging modalities. Output is displayed for physician interpretation to aid in diagnosing disease or abnormalities. The system benefits patients by providing non-invasive visualization of internal structures and blood flow.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, bench testing, and compliance with safety standards for diagnostic ultrasound systems.

Technological Characteristics

Diagnostic ultrasound system using piezo-electric transducers. Modalities include B-mode, M-mode, Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD). Complies with electrical and physical safety standards. Acoustic power output levels are within FDA limits. Patient contact materials evaluated for safety. System utilizes standard ultrasound signal processing for image and Doppler display.

Indications for Use

Indicated for diagnostic ultrasound imaging and Doppler analysis of the human body, including fetal, abdominal, intra-operative, pediatric, small organ (breast, testes, thyroid), neonatal cephalic, adult cephalic, cardiac (adult/pediatric), transrectal, transvaginal, peripheral vessel, and laparoscopic applications.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Aloka SSD-1700
• Aloka Omniview

Submission Summary (Full Text)

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K972465
P. 1 of 2

AUG 1 5 997

#### 1. 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-1400 diagnostic ultrasound system and associated transducers. The address is:

10 Fairfield Boulevard Wallingford, CT. 06492

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

The proprietary name is the Aloka SSD-1400 diagnostic ultrasound system. The common name for this type of device is a diagnostic ultrasound system.

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

90 IYN - System, Imaging, Pulsed Doppler, Ultrasonic 90 IYO - System, Imaging, Pulsed Echo, Ultrasonic 90 ITX - Transducer, Ultrasonic, Diagnostic

The above as stated in 21 CFR, part 892.1550, 892.1560 and 892.1570, have been classified as regulatory Class II.

The Aloka SSD-1400 is substantially equivalent to the Aloka SSD-1700 and Aloka Omniview diagnostic ultrasound systems and transducers. The Aloka SSD-1700 was originally cleared for market via the 510(k) process in 1997, the Omniview was cleared in 1996.

The Aloka SSD-1400 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 an image. The Aloka SSD-1400 can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

The Aloka SSD-1400, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.

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

K972465
P. 2 of 2

The Aloka SSD-1400 diagnostic ultrasound system with gray-scale and Doppler imaging modalities is similar in technological characteristics to ultrasound systems marketed by Aloka and others:

- The SSD-1400 is indicated for the same diagnostic ultrasound applications as other . products currently marketed by Aloka and others.
- The SSD-1400 has the same gray-scale and Doppler abilities as other products . currently offered by Aloka and others.
- The SSD-1400 uses essentially the same technologies for imaging, Doppler functions . and signal processing as other products currently marketed by Aloka and others.
- The SSD-1400 has the same method of use as other products currently marketed by . Aloka and others.
- The SSD-1400 acoustic power output levels are below the maximum levels allowed . by the FDA.
- The SSD-1400 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-1400 have been . evaluated and found to be safe for this application.
- The SSD-1400 complies with the same electrical and physical safety standards as . other products currently marketed by Aloka.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 1997

Paul D. Smolenski Manager, Quality and Regulatory Affairs ALOKA Co., Inc. 10 Fairfield Boulevard Wallingford, CT 06492-7502

Re: K972465 ALOKA SSD-1400 Diagnostic Ultrasound System Dated: June 30, 1997 Received: July 1, 1997 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Smolenski:

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 use stated in the enclosure) to 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 Act The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the ALOKA SSD-1400 Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

| ASU-35WL-10 | ASU-66 | UST-2266-5 | UST-5524-7.5 |
|--------------|--------------|---------------|--------------|
| UST-5536-7.5 | UST-579T-7.5 | UST-672-5/7.5 | UST-670P-5 |
| UST-979-3.5 | UST-984P-5 | UST-978-7.5 | UST-995-7.5 |

If your device is classified (see above) into either class III (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 regulation (CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification sybmission does not affect any obligation vou might have under sections 531 through 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 ciass 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.

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

#### Page 2 - Mr. Paul Smolenski

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 invitro 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 yours,

Ehrid A. Sejerm

fir
L
R

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

:د0(k) Number (if known): unknown at submission Device Name: Aloka SSD-1400 Diagnostic Ultrasound System

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

Indications for Use: Diagnostic Ultrasound imaging and Doppler analysis 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 | | ✓ | ✓ | ✓ | | | | | See Below | |
| Abdominal | | ✓ | ✓ | ✓ | | | | | See Below | |
| Intra-Operative | | ✓ | ✓ | ✓ | | | | | See Below | |
| Intra-Operative | | ✓ | ✓ | ✓ | | | | | See Below | |
| Neurological | | | | | | | | | | |
| Pediatric | | ✓ | ✓ | ✓ | | | | | See Below | |
| Small Organ | | ✓ | ✓ | ✓ | | | | | See Below | |
| Neonatal Cephalic | | ✓ | ✓ | ✓ | | | | | See Below | |
| Adult Cephalic | | ✓ | ✓ | ✓ | | | | | See Below | |
| Cardiac Adult | | ✓ | ✓ | ✓ | ✓ | | | | See Below | |
| Cardiac Pediatric | | ✓ | ✓ | ✓ | ✓ | | | | See Below | |
| Transesophageal | | | | | | | | | | |
| Isrectal | | ✓ | ✓ | ✓ | | | | | See Below | |
| Transvaginal | | ✓ | ✓ | ✓ | | | | | See Below | |
| Transuretheral | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | ✓ | ✓ | ✓ | ✓ | | | | See Below | |
| Laparoscopic | | ✓ | ✓ | ✓ | | | | | See Below | |

Combined Modes: B/M, B/PWD 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)

Qirist A. Beyermann
(Division Sign-Off)

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

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

د 10(k) Number (if known): ر Device Name:

unknown at submission ASU-35WL-10

K972465

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

- Indications for Use: - Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows:

| | 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 | | ✓ | ✓ | | | | | | B/M | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| asrectal | | | | | | | | | | |
| ransvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| 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)

Thind A. Segerom

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

Radiological Devices
510(k) Number K972465

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

۔۔ 10(k) Number (if known): Device Name:

unknown at submission ASU-66

(972465

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

Diagnostic Ultrasound imaging and Doppler analysis 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 | | ✓ | ✓ | ✓ | | | | | B/M, B/PWD | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| insrectal | | | | | | | | | | |
| transvaginal | | ✓ | ✓ | ✓ | | | | | B/M, B/PWD | |
| Transuretheral | | | | | | | | | | |
| 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. Keyram
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, Ind Radiclogical Devices

10(k) Number K472465

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

כ 10(k) Number (if known): unknown at submission UST-2266-5 Device Name:

K972465

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

Indications for Use. Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows:

| 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 | | | | | | | | | | |
| 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 G. Seegborn

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

510(k) Number K972465

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

د 10(k) Number (if known): Device Name:

unknown at submission UST-5524-7.5

972465

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

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

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

Combined Modes: B/M, B/PWD 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)

Prescription Use (Per 21 CFR 801.109)

David A. Heymann

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

510(k) Number K112465

7

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

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

unknown at submission UST-5536-7.5 Transducer

K972465

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

Indications for Use: Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: i

| | MODES of OPERATION | | | | | | | | | |
|-------------------|--------------------|---|---|-----|-----|---------|-----------|-----|-----------|-------|
| Clinical | A | B | M | PWD | CWD | Color | Amplitude | CVI | Combined | Other |
| Application | | | | | | Doppler | Doppler | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| nsrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | V | V | V | V | | | | | See Below | |

Combined Modes: B/M, B/PWD 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)

Cilvin C. Eggert

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

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

د 10(k) Number (if known): Device Name:

{

unknown at submission UST-579T-7.5

<972465

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

Diagnostic Ultrasound imaging and Doppler analysis 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 | | ✓ | ✓ | ✓ | | | | | See Below | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | ✓ | ✓ | ✓ | | | | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| nsrectal | | | | | | | | | | |
| transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | ✓ | ✓ | ✓ | | | | | See Below | |
| 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)

Claird Ch. de yorm

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

510(k) Number K972465

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

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

unknown at submission UST-672-517.5

K972465

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

Diagnostic Ultrasound imaging and Doppler analysis 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 | | ✓ | ✓ | ✓ | | | | | See Below | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| nsrectal | | ✓ | ✓ | ✓ | | | | | See Below | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| 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)

David C. Beynon
(Division Sign-off)

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

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

د 10(k) Number (if known): Device Name:

unknown at submission UST-670P-5

K972465

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

Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: ----Indications for Use:

| Clinical<br>Application | MODES of OPERATION | | | | | | | | | |
|-------------------------|--------------------|---|---|-----|-----|------------------|----------------------|-----|-----------|-------|
| | 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 | | | | | | | | | | |
| insrectal | | ✓ | ✓ | ✓ | | | | | See Below | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Combined Modes: B/M, B/PWD 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. Bergman

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

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

:10(k) Number (if known)د Device Name:

unknown at submission UST-979-3.5

K972465

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

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

| | MODES of OPERATION | | | | | | | | | |
|---------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|-----|-----------|-------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other |
| Opthalmic | | | | | | | | | | |
| Fetal | | ✓ | ✓ | ✓ | | | | | See Below | |
| Abdominal | | ✓ | ✓ | ✓ | | | | | See Below | |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | ✓ | ✓ | ✓ | | | | | See Below | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| insrectal | | | | | | | | | | |
| transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Combined Modes: B/M, B/PWD 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. Seymin

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

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

ر 10(k) Number (if known): Device Name:

unknown at submission UST-984P-5

K972465

# Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging and Doppler analysis 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 | | ✓ | ✓ | ✓ | | | | | See Below | | |
| Abdominal | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| ansrectal | | | | | | | | | | | |
| transvaginal | | ✓ | ✓ | ✓ | | | | | See Below | | |
| Transuretheral | | | | | | | | | | | |
| Intraluminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

Combined Modes: B/M, B/PWD 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. Jessop

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

510(k) Number K972469

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

د 10(k) Number (if known): Device Name:

unknown at submission UST-987-7.5

K972465

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

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

| | 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 | | ✓ | ✓ | ✓ | | | | | See Below | |
| Intra-Operative<br>Neurological | | ✓ | ✓ | ✓ | | | | | See Below | |
| Pediatric | | | | | | | | | | |
| Small Organ | | ✓ | ✓ | ✓ | | | | | See Below | |
| Neonatal Cephalic | | ✓ | ✓ | ✓ | | | | | See Below | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Combined Modes: B/M, B/PWD 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, Office of Device Evaluatition (ODE)

David C. Seymour
(Division Sign-Off)

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

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

ر 10(k) Number (if known): Device Name:

unknown at submission UST-995-7.5

1972465

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

- Indications for Use: Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows:

| | MODES of OPERATION | | | | | | | | | |
|---------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|-----|-----------|-------|
| Clinical | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | CVI | Combined | Other |
| Application | | | | | | | | | | |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | ✓ | ✓ | ✓ | | | | | See Below | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | ✓ | ✓ | ✓ | | | | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| (transrectal | | | | | | | | | | |
| transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraluminal | | | | | | | | | | |
| Peripheral Vessel | | ✓ | ✓ | ✓ | | | | | See Below | |
| 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)

David A. Segerson

Division Sign-Off Division of Reproductive, Abdominal, EN and Radiglogical Dovi 510(k) Number