SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM by ALOKA CO., LTD.

The SSD-1000 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-1400 is not indicated for ophthalmic applications.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (followed by tables listing specific clinical applications and modes of operation for the system and various transducers).

Device Description

The SSD-1000 makes no changes to the indications for use, the ultrasound generator, transducer(s), controls, and signal processing technologies. There are no new system functions added, significant new clinical information provided or significant claims of added effectiveness. In addition, clinical applications/modes of operation provide no new significant interpretation of predicate device; the SSD-1400.

AI/ML Overview

The Aloka SSD-1000 Diagnostic Ultrasound System provides diagnostic ultrasound imaging and fluid flow analysis for various clinical applications. The study provided does not detail specific quantitative acceptance criteria or a study designed to prove these criteria were met. Instead, the document establishes substantial equivalence to a predicate device (SSD-1400, K972465) by demonstrating that the SSD-1000 makes no changes to the indications for use, ultrasound generator, transducers, controls, and signal processing technologies. No new system functions, significant new clinical information, or claims of added effectiveness are noted.

The acceptance criteria are implicitly based on the substantial equivalence of the new device's capabilities to the cleared predicate device. The performance of the device is reported through a list of clinical applications and modes of operation for which the device and its various transducers are intended.

1. Table of Acceptance Criteria and Reported Device Performance:

Since no specific quantitative acceptance criteria were defined in the provided text, the criteria are implicitly that the device performs equivalently to the predicate device for the listed clinical applications and modes. The reported device performance is the scope of its intended uses.

SSD-1000 Diagnostic Ultrasound System:

Clinical Application	Modes of Operation (B/M)
Fetal	E, E
Abdominal	E, E
Intraoperative	E, E
Intraoperative Neurological	E, E
Pediatric	E, E
Small Organ	E, E
Neonatal Cephalic	E, E
Adult Cephalic	E, E
Cardiac	E, E
Transrectal	E, E
Transvaginal	E, E
Peripheral Vascular	E, E
Laparoscopic	E, E

Note: 'E' indicates the application/mode was added under Appendix E, signifying it's an intended use derived from equivalence to the predicate device.

Selected Transducers and their Clinical Applications/Modes:
(Example for a few transducers, as the full list is extensive in the original document)

ASU-35-5 (K983879):
- Small Organ: P, P
- Cardiac: P, P
ASU-35B-5 (Appendix E):
- Small Organ: E, E
- Cardiac: E, E
ASU-1000C-3.5 (Appendix E):
- Fetal: E, E
- Abdominal: E, E
- Transvaginal: E, E
UST-978-3.5 (Appendix E):
- Abdominal: E, E
- Pediatric: E, E
UST-984P-5 (K983879):
- Fetal: E, E
- Transvaginal: E, E
UST-990-5 (K009793):
- Fetal: P, P
- Abdominal: P, P
- Transvaginal: P, P
UST-5524-5 (K985879):
- Small Organ: P, P
- Peripheral Vascular: P, P
UST-5534T-7.5 (K003739):
- Intraoperative: P, P
- Small Organ: P, P
- Peripheral Vascular: P, P
UST-5710-7.5 (K00379):
- Small Organ: P, P
UST-5818-5 (Appendix E):
- Intraoperative: E, E
- Small Organ: E, E
- Peripheral Vascular: E, E
UST-5819T-5 (Appendix E):
- Abdominal: E, E
- Intraoperative: E, E
- Small Organ: E, E
UST-9101-7.5 (K003739):
- Abdominal: P, P, P
- Pediatric: P, P
UST-9102-3.5 (Appendix E):
- Abdominal: E, E
UST-9103-5 (Appendix E):
- Fetal: E, E
- Abdominal: E, E
- Transvaginal: E, E
UST-9104-5 (Appendix E):
- Intraoperative: E, E
- Neonatal Cephalic: E, E, E
UST-9112-5 (Appendix E):
- Fetal: E, E
- Transvaginal: E, E
UST-9116P-5 (Appendix E):
- Intraoperative: E, E, E
- Intraoperative Neurological: E, E, E

2. Sample size used for the test set and the data provenance:

The provided 510(k) summary does not mention a specific test set or data provenance from a prospective or retrospective study for verifying performance against acceptance criteria. The approval is based on substantial equivalence to a predicate device. A post-market surveillance requirement is mentioned in page 3 of the document, requesting "acoustic output measurements based on production line devices" prior to shipping the first device, but this is related to safety and manufacturing compliance rather than clinical performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The approval is based on substantial equivalence, not on a new clinical study requiring ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No adjudication method is mentioned, as there is no specific test set described in the context of clinical performance evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study is mentioned. This device is a diagnostic ultrasound system, not an AI-powered device, so human reader improvement with AI assistance is not applicable in this context.

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

Not applicable, as this is a medical device for imaging, not an algorithm, and it requires a human operator for its intended use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The filing is based on substantial equivalence to a predicate device, meaning its performance characteristics are deemed equivalent to a device already on the market, rather than requiring new ground truth data for novel claims.

8. The sample size for the training set:

Not applicable, as this is a medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, for the same reason as above.

Summary

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AUG 3 0 2001

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-1000 Diagnostic Ultrasound System
Device Common Name	Diagnostic ultrasound system

Classification	The charts below list the Regulatory Class and Device Codes.
----------------	--------------------------------------------------------------

Subject	Description
Regulatory Class	Class II
Review Category	Tier II

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	892.1560

Continued on next page

Aloka Company, Ltd.

Accessories

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510(k) Summary, Continued

Identification of predicate devices	The SSD-1000 (Appendix E) is substantially equivalent to the SSD-1400, which is subject of a submitted and cleared 510(k): K972465.
Device Description	The SSD-1000 makes no changes to the indications for use, the ultrasound generator, transducer(s), controls, and signal processing technologies. There are no new system functions added, significant new clinical information provided or significant claims of added effectiveness. In addition, clinical applications/modes of operation provide no new significant interpretation of predicate device; the SSD-1400.
Probes	Only those probe that are the subject of the submitted and cleared 510(k) for the SSD-1400 have been added to the SSD-1000. Probes that have been added to the SSD-1400 using Appendix E and are intended to be used with the SSD-1000 are the subjects of this submission. A list of added probes has been provided.
Intended Use	The SSD-1000 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-1400 is not indicated for ophthalmic applications.

Aloka Company, Ltd.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2001

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

Re: K012253

Trade Name: Aloka SSD-1000 Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Regulatory Class: II/21 CFR 892.1570 Product Code: 90 ITX Dated: July 16, 2001 Received: July 18, 2001

Dear Mr. Burroughs:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your became in the device is substantially equivalent (for the indications for use above and we nave acteriment to legally marketed predicate devices marketed in interstate commerce stated in the energister) to regarry int date of the Medical Device Amendments, or to devices that prove to may 20, 177, 0, 1978, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosinede Act (11ct). Tourise), provisions of the Act include requirements for provisions of the Freat First of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for r ins detenminded or backling of the Ultrasound System, as described in your premarket notification:

Transducer Model Number

ASU-35-5 ASU-35B-5 ASU-67 ASU-1000C-3.5 UST-978-3.5 UST-984P-5 UST-990-5

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UST-5524-5
UST-5534T-7.5
UST-5710-7.5
UST-5818-5
UST-5819T-5
UST-9101-7.5
UST-9102-3.5
UST-9103-5
UST-9104-5
UST-9112-5
UST-9116P-5

If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (SC above) this onch additional controls. Existing major regulations (Premarket Approval) it may be subject to back as a little 21, Parts 800 to
affecting your device can be found in the Code of Federal Regulations with the Good allecting your device can be round emmination assumes compliance with the Good 895. A substantially equirement, as set forth in the Quality System Regulation (QS) for Manufacturing Practice requirement, as set read mixed of the through periodic QS
Medical Devices: General (GMP) regulation (21 CFR Part 820) and that the GMP regulation Medical Devices: Gelleral (GMT) regulation (2) - 1. Failure to comply with the GMP regulation (FDA) may inspections, the FDA Will verliy such assamplier of and Drug Administration (FDA) may
may result in regulatory action. In addition, the Food well Register Register and may result in regulatory action. In adultion, and rovice in the Federal Register. Please note: this
publish further announcements concerning your device in the Federal por publish further allinouncements concerning your affect any obligation you may have under
response to your premarket notification does not affect any obligation Control response to your premarket nothrouten acts and more and and on the Electronic Product Radiation Control sections 551 - other Federal laws or regulations.

This determination of substantial equivalence is granted on the condition that print to shipping to I his determination of Substance special report. This report should contain complete the first device, you submit a postered and species is based on production line devices, requested
information, including acoustic output measurements based on production fo information, including acoustic output measurements on 1997 "Information for Manufacturers" in Appendix O, (enclosed) of the Center 3 September 3 3, stems and Transducers." If the special Seeking Marketing Clearance of Diagnostic Craias and 1944
report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved report is incomplete of contails unacceptation varies (engy more of the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and The special report should referent iE'' 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 This letter will anow you to ocgin marketing your alence of your device to a legally marketed

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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, please If you desire of Compliance at (301) 594-4591. Additionally, for questions on the contact the Office or compilance at (vice, please contact the Office of Compliance at (301) 594promotion and advertubility or youlation entitled, "Misbranding by reference to premarket 40.5% Also, prouse note are roganal information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer inay be obtained from and 217.2017 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 Rodgrio C. Perez at (301) 594-1212.

Sincerely yours,

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)

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System/Transducer	System
Model	SSD-1000
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)
Ophthalmic
Fetal		E	E						See Below
Abdominal		E	E						See Below
Intraoperative (specify)		E	E						See Below
Intraoperative Neurological		E	E						See Below
Pediatric		E	E						See Below
Small Organ (specify)		E	E						See Below
Neonatal Cephalic		E	E						See Below
Adult Cephalic		E	E						See Below
Cardiac		E	E						See Below
Transesophageal									See Below
Transrectal		E	E						See Below
Transvaginal		E	E						See Below
Transurethral
Intravascular									See Below
Peripheral Vascular		E	E						See Below
Laparoscopic		E	E						See Below
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other

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

Additional Comments: B/M-Mode

(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

	K012253
	Member

Aloka Company, Ltd.

Page 1 1 of 43

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System/Transducer	Transducer
Model	ASU-35-5
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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P
Neonatal Cephalic
Adult Cephalic
Cardiac		P	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;

Additional Comments:

(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. Brogdom

Division Sign-Off)
ivision of Reproductive, Abdominal,
and Radiological Devices
10kl Numbe K012253

Aloka Company, Ltd.

Page 12 of 43

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System/Transducer	Transducer
Model	ASU-35B-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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E
Neonatal Cephalic
Adult Cephalic
Cardiac		E	E
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:

(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

(División Sign-om)

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

K012253

Aloka Company, Ltd.

Page 13 of 43

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System/Transducer	ransducer
Model	A LA BALL BALL BE A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND
510(k) Number	AnnendixA Book Company

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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		E	E
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:

(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.
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012253
510(k) Number.

Aloka Company, Ltd.

Page 1 4 of 43

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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	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		E	E						See Below
Abdominal		E	E						See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		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: B/M-Mode

(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 Reproductive, Abdominal,
and Radiological Devices K012253
510(k) Number.

Aloka Company, Ltd.

Page 15 of 43

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System/Transducer	Transducer
Model	UST-978-3.5
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)
Ophthalmic
Fetal
Abdominal		E	E						See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric		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

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

Additional Comments: B/M-Mode

(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. H012253

Aloka Company, Ltd.

Page 16 of 43

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System/Transducer	Transducer
Model	UST-984P-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)
Ophthalmic
Fetal		E	E						See Below
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		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: B/M-Mode

(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. boyden

(Division Si Division of Reprod and Radiological Devices 510(k) Number

Aloka Company, Ltd.

Page 17 of 43

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System/Transducer	Transducer
Model	UST-990-5
510(k) Number	K009793

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)
Ophthalmic
Fetal		P	P						See Below
Abdominal		P	P						See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		P	P						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: B/M-Mode

(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

Aloka Company, Ltd.

Page 18 of 43

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

System/Transducer	Transducer
Model	UST-5524-5
510(k) Number	K985879

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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		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: B/M-Mode

(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 and Radiological Devices 510(k) Number

Aloka Company, Ltd.

Page 19 of 43

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System/Transducer	l ransducer
Model	UST-5534T-7.5
Superior of Children Company of American Comments of the First of the First of the First of the First of the First of the research of the research of the research of the rese510(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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P						See Below
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		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: B/M-Mode

ال

(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. Braden
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K012253

Aloka Company, Ltd.

Page 20 of 43

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System/Transducer	Transducer
Model	UST-5710-7.5
510(k) Number	K00379

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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P						See Below
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: B/M-Mode

(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-Division of Reprodu and Radiological Devic 510(k) Number

Aloka Company, Ltd.

Page 21 of 43

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

System/Transducer	ransducer
Inde
<10/1/1 Number	nnendix------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		E	E						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		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: B/M-Mode

(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. and Radiological Device 510(k) Number

Aloka Company, Ltd.

Page 22 of 43

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

System/Transducer	Transducer
Model	UST-5819T-5
510(k) Number	Appendix E

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal									See Below
Intraoperative (specify)		E	E
Intraoperative Neurological
Pediatric
Small Organ (specify)		E	E						See Below
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: B/M-Mode

(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)

Dancy C. bogdon

Division Sign-Off Division of Reproductiv and Radiological Devices 510(k) Number __

Aloka Company, Ltd.

Page 23 of 43

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

System/Transducer	Transducer
Model	UST-9101-7.5
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)
Ophthalmic
Fetal
Abdominal		P	P	P					See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric		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:

(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 Division of Reproduc andor and Radiological Device 510(k) Number _

Aloka Company, Ltd.

Page 24 of 43

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

System/Transducer	l ransducer
Model	· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
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)
Ophthalmic
Fetal
Abdominal		E	E						See below
Intraoperative (specify)
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: B/M-Mode

(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, Abdontijnal,

Division of Reproductive, Abdominal,
and Radiological Devices
510(K) Number IKO12253

Aloka Company, Ltd.

Page 25 of 43

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

System/Transducer	Transducer
Model	UST-9103-5
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)
Ophthalmic
Fetal		E	E						See Below
Abdominal		E	E						See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		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: B/M-Mode

(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 ________________________________________________________________________________________________________________________________________________________________

Page 26 of 43

Aloka Company, Ltd.

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

System/Transducer	Transducer
Model	UST-9104-5
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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		E	E						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		E	E	E					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: B/M-Mode

(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 of Regular Braterna and Radiological Devis 510%) Number

Aloka Company, Ltd.

Page 27 of 43

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

System/Transducer	Transducer
Model	UST-9112-5
510(k) Number	Appendix E

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		E	E						See Below
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		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: B/M-Mode

(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
	Area of Reproductive, Abdominal,
and Radiological Devices	K012253
113kj Number

Aloka Company, Ltd.

Page 28 of 43

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

System/Transducer	Transducer
Model	UST-9116P-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)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		E	E	E					See Below
Intraoperative Neurological		E	E	E					See Below
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: B/M-Mode

(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 Division of Reproductive, Abdo rinal, and Radiological Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Aloka Company, Ltd.

Page 29 of 43

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.