SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM

K012080 · Aloka Co., Ltd. · IYN · Aug 29, 2001 · Radiology

Device Facts

• Record ID: K012080
• Device Name: SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Aloka Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Aug 29, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SSD-5000 Diagnostic Ultrasound System and Transducers be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Abdominal, Gastrointestinal, Trauma, Surgical and Endoscopic applications. The Aloka SSD-5500 is not indicated for ophthalmic applications.

Device Story

SSD-5000 is a diagnostic ultrasound system; utilizes ultrasound transducers to acquire images or fluid flow data from human body; processes signals to generate visual output for clinical diagnosis; operated by healthcare professionals in clinical settings; output used for diagnostic imaging in various specialties including cardiac, abdominal, and vascular; aids clinical decision-making by providing real-time anatomical and physiological visualization; benefits patients through non-invasive diagnostic assessment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Diagnostic ultrasound system; utilizes ultrasound transducers; supports multiple modes including B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Color Velocity Imaging; connectivity via standard ultrasound system interfaces; software-controlled signal processing.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body in cardiac, gynecological, neurological, obstetrical, neonatal, pediatric, perinatal, radiological, vascular, urological, abdominal, gastrointestinal, trauma, surgical, and endoscopic applications. Prescription use only.

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

• SSD-5500 (K992663, K002784, K011315, K011457)

Submission Summary (Full Text)

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

K012050

# 510(k) Summary

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

| Submitter's Name and Address | Aloka Co., Ltd.<br>10 Fairfield Boulevard<br>Wallingford, CT 06492 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact's Name, Title, Address and Telephone Number | Kelvin Burroughs<br>Regulatory Affairs/Quality Assurance Coordinator<br>Aloka Co., Ltd.<br>10 Fairfield Boulevard<br>Wallingford, CT 06492<br>[phone] |
| Device Proprietary Name | SSD-5000 Diagnostic Ultrasound System |
| Device Common Name | Diagnostic ultrasound system |
| Classification | The charts below list the Regulatory Class and Device Codes. |

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Book Company<br>LENNER BE REE<br>An And Black I | A LINER I BOOK ON REAL PRODUCT CONSULER AND<br>----------<br><br>-----------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>10-01-00-01-01-01<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>No. of an a sep-<br>.<br>A LABOR AN CHANADA AND |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>A CONSULATION COLORIAL COLLECTION COLLEGIONAL COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECT<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <br>I BET REPORTER COLOR LE RESER AND<br>A<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Company Company<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>--------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| <br>Concertion Colline<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>.<br>Acres of the commended to children | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>.<br><br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>E L C S M L L S<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Commender of the control of the control of the production of each and<br>-----------------------------------<br>FILE IN ROLL I DOLL I BOR MARK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOM BOOK BOOM BOOK BOOK BOOK BOO<br>and the characterial consideration to the collection of the collection of the collection of the collection of the complex of the complex of the complex of the complex of the<br>Call a commension come come come come<br>--------------------------------------------------------------------------------------------------------------<br>****<br>Birth College of Children And Concession & Con- |

| Code | Description | Regulation |
|--------|-----------------------------------------------------------|------------|
| 90 ITX | Transducer, Ultrasonic, Diagnostic | 892.1570 |
| 90 IYN | Ultrasonic, Pulsed Doppler Imaging System | 892.1550 |
| 90 IYO | Ultrasonic, Pulsed Echo Imaging System and<br>Accessories | 892.1560 |

Continued on next page

Aloka Company, Ltd.

Page 8 of 64

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

### 510(k) Summary, Continued

| Identification of<br>predicate<br>devices | The SSD-5000 is substantially equivalent to the SSD-5500, which is subject<br>of the following submitted and cleared 510(k)s: K992663, K002784,<br>K011315 and K011457. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The SSD-5000 makes no changes to the indications for use, the ultrasound<br>generator, transducer(s), controls, or signal processing technologies. There are<br>no new system functions, significant new clinical information provided or<br>significant claims of added effectiveness. In addition, clinical<br>applications/modes of operation provide no new significant interpretation of<br>the predicate device, the SSD-5500. |
| Probes | Probe that are the subject of a submitted and cleared 510(k) for the SSD-5500<br>have already been added to the SSD-5000. New probes and additional<br>probes for used with the SSD-5000 are the subjects of this submission. |
| Intended Use | The SSD-5000 Diagnostic Ultrasound System and Transducers be used for<br>diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological,<br>Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological,<br>Abdominal, Gastrointestinal, Trauma, Surgical and Endoscopic applications.<br>The Aloka SSD-5500 is not indicated for ophthalmic applications. |

:

Aloka Company, Ltd.

・ :

... ...

:

Page 9 of 64

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 image of an eagle with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 2 9 2001

Mr. Kelvin Burroughs Coordinator, Regulatory Affairs & Quality Assurance ALOKA Co., Ltd. 10 Fairfield Boulevard WALLINGFORD CT 06492-7502

Re: K012080

Trade Name: Aloka SSD-5000 Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Regulatory Class: II/21 CFR 892.1560 Product code: 90 IYO Dated: June 29, 2001 Received: July 3, 2001

Dear Mr. Burroughs:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed four becally be is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energiale, to regary inn date of the Medical Device Amendments, or to devices that prior to may 20, 1978, and ance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costical Fet (110). I The general controls provisions of the Act include requirements for provisions of the rea- rea- reas good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for 1 ms determination of bacement Ultrasound System, as described in your premarket notification:

Transducer Model Number

ASU-67 ASU-1000C-3.5 ASU-1002 UST-2265-2 UST-52718-5

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

UST-5281-5
UST-5284-2.5
UST-5285-3.5
UST-5293-5
UST-5294-5
UST-5296
UST-5297
UST-5524-5
UST-5524-7.5
UST-5531
UST-5534T-7.5
UST-5543
UST-5545
UST-5712
UST-9101-7.5
UST-9104-5
UST-9114-3.5
UST-9115-5

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) this uch additional (x) { = { (Premarket Approval) it may be subject to back as a legulations, Title 21, Parts 800 to affecting your device can be round the equivalent determination assumes compliance with the Good 895. A substantially Cquirement, as set forth in the Quality System Regulation (OS) for Manufacturing Fractice requirement, as set read man and that, through periodic QS
Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, the CMB verylation Medical Devices: General (GMT) regulation (21 - 2 Reilure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may may result in regulatory action: in adultion, are device in the Federal Register. Please note: this publish further anilouncements concerning your affect any obligation you may have under response to your premarket notification active Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This determination of substantial equivalence is granted on the condition that prior to shipping a I his detenmination of Substantial oquiralers special report. This report should contain complete the first device, you submit a postoleatures special in production line devices, requested information, menuding acousul of the Center's September 30, 1997 "Information for Manufacturers" In Appellulx U, (enclosed) of the Oct.er violente of Systems and Transducers'. If the special Seeking Marketing Clearance of Diagnound Of Lines (e.g., acoustic output greater than approved report is incomplete of comailis unaccepably furted (orgi, as the production units which as a result may be considered adulterated or misbranded.

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

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, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Sincerely vours.

Nancy C. Brogdon

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

Enclosure(s)

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

| System/Transducer | A LIES & LANDRIA LA BE CO<br>Veter<br> |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -1000 | -000 |
| <br>Annual A L Children<br>510/k) Number | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>AND AND AN |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

N= new indication; P= previously cleared by FDA; E= added under Appendix E;

Additional Comments: BIA-SMA.

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,

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

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

and Radiological Devic 510(k) Number

Page 1 1 of 64

Aloka Company, Ltd.

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

| A<br>Svstem/Transducer | would and annual and the processor of the arts of the only of the only of the can the comments<br>ransqucer |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| N 0.510 | |
| 510/k) Number<br> | |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

indication; P= previously cleared by FDA; E= added under Appendix E;

Additional Comments: B/A-SMA.

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,

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

Prescription Use (Per 21 CFR 801.109)

Nancy C bogdon

(Division Sign-Off)

Division of Reproducti ve. Abdom and Radiological Devices 510(k) Number

Aloka Company, Ltd.

Page 12 of 64

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

| System/Transducer | Transducer |
|-------------------|---------------|
| Model | ASU-1000C-3.5 |
| 510(k) Number | Appendix E |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

N= new indication: P= previously cleared by FDA: E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD, BIA-SMA.

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. hogdon

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

Aloka Company, Ltd.

SSD-5000 Abbreviated 510(k) Submission

Page 1 3 of 64

F

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

| System/Transducer | <br>ransducer |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mone | 1000 |
| 510(k) Number | אותו<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

N= new indication; P= previously cleared by FDA; E= added under Appendix E;

Additional Comments: BIA-SMA

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. hogdon

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

Aloka Company, Ltd.

Page 14 of 64

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

| ----------<br>Transancer | I assessment 1 a new an<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>ransdicer<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br> |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>10/7 | <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>11 11 100000 Boom L Book L<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A contra come of<br>Call of Call of Children a<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

N= new indication; P= previously cleared by FDA; E= added under Appendix E;

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD, Additional Comments: BIA-SMA.

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. hogdon

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

Aloka Company, Ltd.

Page 1 5 of 64

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

| System/Transducer | ransducer |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Model | 1000000 |
| 1 1 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4<br>510/k) Number | Annendix 1 |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

new indication; P= previously cleared by FDA; E= added under Appendix E;

Additional Comments: BIA-SMA.

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. hodson
(Division Sign-Off)

Division of Reproduct ve. Abdor and Radiological Devices 510(k) Number

Aloka Company, Ltd.

Page 1 6 of 64

I

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

| System/Transducer | ransducer |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| vindel | . |
| 510(k) Number | endix<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

indication; P= previously cleared by FDA; E= added under Appendix E;

Additional Comments: BIA-SMA

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. hogdon

(Division Sign-Off) Division of Reproductive and Radiological Devices 51(Yk) Number

Page 1 7 of 64

Aloka Company, Ltd.

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

| System/Transducer | Transducer |
|-------------------|--------------|
| Model | UST-5284-2.5 |
| 510(k) Number | |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

N= new indication; P= previously cleared by FDA; E= added under Appendix E;

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD, Additional Comments: BIA-SMA.

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. brondom

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

and Radiological Devices 510(k) Number

Aloka Company, Ltd.

Page 1 8 of 64

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

| ------------<br>Sustem/Transducer | <br>--------------------------------------<br>August Chicago<br><br>Property of Children or successful and any<br>LINE CONS LE RIGE<br>ransducer<br>--------- |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mon | ------------ |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>510/k) Number | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

N= new indication; P= previously cleared by FDA; E= added under Appendix E;

Additional Comments: BIA-SMA.

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. hogdon

(Division Sign-Off) Division of Reproduc and Radiological Device 18:13

Page 1 9 of 64

Aloka Company, Ltd.

Page 19 of 64

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

| System/Transducer | Transducer |
|-------------------|------------|
| Model | UST-5293-5 |
| 510(k) Number | K003739 |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

new indication; P= previously cleared by FDA; E= added under Appendix E;

Additional Comments: BIA-SMA.

Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012080
510(k) Number

Aloka Company, Ltd.

Page 20 of 64

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

| System/Transducer | Transducer |
|-------------------|------------|
| Model | UST-5294-5 |
| 510(k) Number | Appendix E |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows. | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | Modes of operation | | | | | | | | | | |
| | A…