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 Description

The SSD-5000 makes no changes to the indications for use, the ultrasound generator, transducer(s), controls, or signal processing technologies. There are no new system functions, significant new clinical information provided or significant claims of added effectiveness. In addition, clinical applications/modes of operation provide no new significant interpretation of the predicate device, the SSD-5500.

AI/ML Overview

The provided text is a 510(k) Summary for the Aloka SSD-5000 Diagnostic Ultrasound System. This document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended uses of various transducers. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, data provenance, expert qualifications, adjudication methods, or comparative effectiveness studies of AI.

The tables within the document (from {5} to {28}) list system/transducer models and their intended clinical applications and modes of operation. These tables show whether a particular application/mode is "New" (N), "Previously cleared by FDA" (P), or "Added under Appendix E" (E). This is a description of the device's capabilities and regulatory status, not a report of performance against acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device (SSD-5500) and expanding intended uses of transducers, implying that meeting safety and effectiveness standards comparable to the predicate is the "acceptance criterion" from a regulatory perspective.
Reported Device Performance: Not reported in terms of specific metrics like sensitivity, specificity, or accuracy. The performance is implied to be equivalent to the predicate device for its stated intended uses.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which often relies on comparison to a legally marketed predicate device rather than new clinical outcome studies for performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of human readers improve with AI vs without AI assistance

This information is not provided in the document. The device described is a diagnostic ultrasound system, not an AI-powered image analysis tool, making an MRMC study related to "AI vs without AI assistance" irrelevant in this context.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document. The device is an ultrasound system, not an algorithm, so this type of study is not applicable.

7. The Type of Ground Truth Used

This information is not provided in the document.

8. The Sample Size for the Training Set

This information is not provided in the document.

9. How the Ground Truth for the Training Set was Established

This information is not provided in the document.

Summary of Device Capabilities (from the tables):

The document details the intended uses for various transducers with the Aloka SSD-5000 Diagnostic Ultrasound System across a wide range of clinical applications. The modes of operation available for these applications include: A (A-mode), B (B-mode), M (M-mode), PWD (Pulsed Wave Doppler), CWD (Continuous Wave Doppler), Color Doppler, Amplitude Doppler, and sometimes Color Velocity Imaging. "Mixed mode operation" is also noted to include combinations like B/M, B/PWD, B/CD, M/CD, and B/CD/PWD, and B/A-SMA.

Clinical Applications for the SSD-5000 System (as listed):

Cardiac
Gynecological
Neurological
Obstetrical
Neonatal
Pediatric
Perinatal
Radiological
Vascular
Urological
Abdominal
Gastrointestinal
Trauma
Surgical
Endoscopic

Note: The system is not indicated for ophthalmic applications.

Summary

{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.10 Fairfield BoulevardWallingford, CT 06492
Contact's Name, Title, Address and Telephone Number	Kelvin BurroughsRegulatory Affairs/Quality Assurance CoordinatorAloka Co., Ltd.10 Fairfield BoulevardWallingford, CT 06492(203) 269-5088
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.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Book CompanyLENNER BE REEAn And Black I	A LINER I BOOK ON REAL PRODUCT CONSULER AND---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------10-01-00-01-01-01------------------------------------------------------------------------------------------------------------------------------------------------------------------------------No. of an a sep-.A LABOR AN CHANADA AND
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.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.A CONSULATION COLORIAL COLLECTION COLLEGIONAL COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECT------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

I BET REPORTER COLOR LE RESER ANDA.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Company Company.--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concertion Colline------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.Acres of the commended to children

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------E L C S M L L S------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Commender of the control of the control of the production of each and-----------------------------------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 BOOand 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 theCall a commension come come come come--------------------------------------------------------------------------------------------------------------****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 andAccessories	892.1560

Continued on next page

Aloka Company, Ltd.

Page 8 of 64

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

510(k) Summary, Continued

Identification ofpredicatedevices	The SSD-5000 is substantially equivalent to the SSD-5500, which is subjectof the following submitted and cleared 510(k)s: K992663, K002784,K011315 and K011457.
DeviceDescription	The SSD-5000 makes no changes to the indications for use, the ultrasoundgenerator, transducer(s), controls, or signal processing technologies. There areno new system functions, significant new clinical information provided orsignificant claims of added effectiveness. In addition, clinicalapplications/modes of operation provide no new significant interpretation ofthe predicate device, the SSD-5500.
Probes	Probe that are the subject of a submitted and cleared 510(k) for the SSD-5500have already been added to the SSD-5000. New probes and additionalprobes for used with the SSD-5000 are the subjects of this submission.
Intended Use	The SSD-5000 Diagnostic Ultrasound System and Transducers be used fordiagnostic 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.

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.

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 COVeter
-1000	-000
Annual A L Children510/k) Number	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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}------------------------------------------------

ASvstem/Transducer	would and annual and the processor of the arts of the only of the only of the can the commentsransqucer
N 0.510
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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(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

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

System/Transducer	ransducer
Mone	1000
510(k) Number	אותו------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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}------------------------------------------------

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----------Transancer

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------10/7

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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 4510/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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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

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

System/Transducer	ransducer
vindel	.
510(k) Number	endix.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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}------------------------------------------------

------------Sustem/Transducer	--------------------------------------August ChicagoProperty of Children or successful and anyLINE CONS LE RIGEransducer---------
Mon	------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	E	E	E	E	E	E	E		See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other

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

Additional Comments:

Mixed mode operation includes B/M, B/CD, M/CD, B/A-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 Reproduc ve, At and Radiological Devices 510(k) Number _

Aloka Company, Ltd.

Page 2 1 of 64

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

System/Transducer	Transducer
Model	UST-5296
510(k) Number	Appendix E

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		E	E	E		E	E		See Below
Small Organ (specify)
Neonatal Cephalic		E	E	E		E	E		See Below
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

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

Additional Comments:

Mixed mode operation includes B/M, 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 Reproductiv , Abdomi and Radiological Devices 510(k) Number

Aloka Company, Ltd.

Page 22 of 64

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

System/Transducer	Transducer
Model	UST-5297
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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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: Mixed mode operation includes B/M, B/CD, M/CD, B/CD/PWD, B/A-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 and Radiological Devices

Aloka Company, Ltd.

Page 23 of 64

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

System/Transducer	Transducer
Model	UST-5524-5
510(k) Number	K983879

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P	P	P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P		See Below
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/CD, M/CD,

(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 - 1 - ki Number

Aloka Company, Ltd.

SSD-5000 Abbreviated 510(k) Submission

Page 24 of 64

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

-------------------m/ I ransdricerVCTA.	ransducer
10000	Ann Address of the
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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E	E		E	E		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		E	E	E		E	E		See Below
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/CD, M/CD.

(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
4012080

Aloka Company, Ltd.

Page 25 of 64

SSD-5000 Abbreviated 510(k) Submission

510(k) Number

{20}------------------------------------------------

/TransducerSystem/	schicer

No. of Anticle State an it a come of each. <10/k) Number	A Monton Company of the Arts of Art of Articles

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	ColorDoppler	AmplitudeDoppler	ColorVelocity-Imaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)	P	P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
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:

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

(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 Reproductiv ano Radiological Devices 510(k) Number _

Aloka Company, Ltd.

Page 26 of 64

ge 26 of 64

{21}------------------------------------------------

System/Transducer	Transducer
Model	UST-5534T-7.5
510(k) Number	K963616

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
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/CD, M/CD,

(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 Reproduct
and Radiological Devices
510(k) Number. 4012080

Aloka Company, Ltd.

Page 27 of 64

{22}------------------------------------------------

Sustem/TransducerLEAR MAR LEE MARKE	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ransducerA Children and consideration and concession a parts of the company of the company of the company of the company of the company of the company of the company of the company of
A BOOK LEAST LE BELLER	---------ARMANAGE
510/b) NumberRE LEIN BELLERS BELLERS	--------.A PROPERTY OF CALLERY COLLECTION COLLEGION COLLEGION-------LABORAL CLANDLE LEASE LEGION

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E	E		E	E		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		E	E	E		E	E		See Below
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.

(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-O Division of Reprodu and Radiological Do 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Aloka Company, Ltd.

Page 28 of 64

{23}------------------------------------------------

System/Transducer	Transducer
Model	UST-5545
510(k) Number	Appendix E

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E	E	E		E	E		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		E	E	E	E		E	E		See Below
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/CD, M/CD.

(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 Reor tive. Abdominal and Radiologica 510(k) Number

Page 29 of 64

Aloka Company, Ltd.

{24}------------------------------------------------

System/Transducer	ransducer
VI nov	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E	E		E	E		See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		E	E	E		E	E		See Below
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/CD, M/CD.

(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 Reprod and Radiological Devices 510(k) Number

Aloka Company, Ltd.

Page 30 of 64

{25}------------------------------------------------

vstem/Transdicer	-------------------sducer----------------
Mar
------------------510/k) Nomber1	10 10------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P	P		See Below
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
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:

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-Of Division of Repr and Radiologica 510(k) Number

2 30 10 30 31 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 2

Aloka Company, Ltd.

Page 3 1 of 64

{26}------------------------------------------------

System/Transducer	Transducer
Model	UST-9104-5
510(k) Number	K900805

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P		P	P		See Below
Adult Cephalic
Cardiac
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:

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

(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 Dev 510(k) Number

Aloka Company, Ltd.

Page 32 of 64

{27}------------------------------------------------

System/Transducer	Transducer
Model	UST-9114-3.5
510(k) Number	Appendix E

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(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.

(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 Reprod and Radiological 510(k) Number

Aloka Company, Ltd.

Page 33 of 64

{28}------------------------------------------------

System/Transducer	Transducer
Model	UST-9115-5
510(k) Number	Appendix E

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		E	E	E		E	E		See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric		E	E	E		E	E		See Below
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
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:

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,

Division of Replan and Radiologic a 510(k) Number

Page 34 of 64

Aloka Company, Ltd.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.