Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: Fetal, Abdominal, Intra-Operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Transrectal, Transvaginal, Peripheral Vessel, Laparoscopic. Combined Modes: B/M, B/PWD.

Device Description

The Aloka SSD-1400 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into an image. The Aloka SSD-1400 can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

AI/ML Overview

This document is a 510(k) summary for the Aloka SSD-1400 diagnostic ultrasound system and associated transducers, submitted in 1997. It explicitly states that the device is "substantially equivalent" to previously cleared devices (Aloka SSD-1700 and Aloka Omniview) and functions in the same manner. This means that the regulatory approval is based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical performance studies against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document as it pertains to performance studies that are typically required for novel devices or those that cannot demonstrate substantial equivalence to a predicate.

The document focuses on demonstrating substantial equivalence through:

Identical intended use (imaging body structures to aid in diagnosis).
Similar technological characteristics (gray-scale and Doppler abilities, imaging/Doppler functions, signal processing).
Same method of use.
Compliance with FDA acoustic power output levels.
Application of the same Quality Assurance systems.
Evaluated and safe patient contact materials.
Compliance with electrical and physical safety standards.

However, to answer as much as possible based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria for device performance in the way a clinical study would for a novel device. Instead, the acceptance criterion for regulatory clearance is "substantial equivalence" to existing predicate devices (Aloka SSD-1700 and Aloka Omniview).

Acceptance Criteria Category	Acceptance Criteria (from predicate similarity)	Reported Device Performance (from substantial equivalence claim)
Intended Use	Diagnostic ultrasound imaging and Doppler analysis for various clinical applications as established by predicate devices.	The Aloka SSD-1400 is indicated for the same diagnostic ultrasound applications as other products currently marketed by Aloka and others. (Specific applications are detailed for the system and each transducer in the "Indications for Use" forms).
Technological Characteristics	Similar gray-scale and Doppler abilities, imaging/Doppler functions, and signal processing as predicate devices.	The SSD-1400 has the same gray-scale and Doppler abilities as other products currently offered by Aloka and others. The SSD-1400 uses essentially the same technologies for imaging, Doppler functions, and signal processing as other products currently marketed by Aloka and others.
Method of Use	Same method of use as predicate devices.	The SSD-1400 has the same method of use as other products currently marketed by Aloka and others.
Acoustic Power Output	Below maximum levels allowed by FDA.	The SSD-1400 acoustic power output levels are below the maximum levels allowed by the FDA.
Quality Assurance	Subject to the same Quality Assurance systems as predicate devices.	The SSD-1400 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka.
Patient Contact Materials	Safe for application as established by predicate devices.	The patient contact materials used in the probes for the SSD-1400 have been evaluated and found to be safe for this application.
Safety Standards	Compliance with electrical and physical safety standards.	The SSD-1400 complies with the same electrical and physical safety standards as other products currently marketed by Aloka.

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

Sample Size for Test Set: Not applicable. No dedicated "test set" in the context of a clinical performance study with patient data is mentioned or implied for this 510(k) submission. The equivalence is based on engineering characteristics and prior regulatory clearances.
Data Provenance: Not applicable. No new clinical performance data is presented, so there is no country of origin or retrospective/prospective designation for such data.

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

Number of Experts: Not applicable. No ground truth establishment by experts for a test set is described.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This document does not describe an MRMC comparative effectiveness study. The approval is based on substantial equivalence, not on demonstrating improved human reader performance with AI assistance.

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

Standalone Performance Study: No. This device is a diagnostic ultrasound system, not an AI algorithm. Its performance is intrinsically tied to human operation and interpretation.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. No clinical ground truth (e.g., pathology, outcomes data, or expert consensus) for a performance study is described in this 510(k) submission. The regulatory pathway relies on demonstrating equivalent technical specifications and operational safety to predicate devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document is for a traditional diagnostic ultrasound system, not a device incorporating a machine learning algorithm that would require a "training set."

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

How Ground Truth Was Established: Not applicable. As there is no mention of a training set or machine learning components, the concept of establishing ground truth for such a set is not relevant to this submission.

Summary

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

K972465
P. 1 of 2

AUG 1 5 997

1. 510(k) SUMMARY

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

This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-1400 diagnostic ultrasound system and associated transducers. The address is:

10 Fairfield Boulevard Wallingford, CT. 06492

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

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

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

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

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

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

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

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

K972465
P. 2 of 2

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

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

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

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 1997

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

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

Dear Mr. Smolenski:

We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions Act The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, against misbranding and adulteration.

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

Transducer Model Number

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

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification sybmission does not affect any obligation vou might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into ciass I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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

Page 2 - Mr. Paul Smolenski

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21-CFR Part 801- and additionally 809-10-for invitro diagnostic devices), please contact the Office of Compliance at (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 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 Paul Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

Ehrid A. Sejerm

fir
L
R

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

Enclosure(s)

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

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

Fill our one form for each ultrasound system and transducer

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

ClinicalApplication	B	M	PWD	CWD	Combined
Opthalmic
Fetal	✓	✓	✓		See Below
Abdominal	✓	✓	✓		See Below
Intra-Operative	✓	✓	✓		See Below
Intra-Operative	✓	✓	✓		See Below
Neurological
Pediatric	✓	✓	✓		See Below
Small Organ	✓	✓	✓		See Below
Neonatal Cephalic	✓	✓	✓		See Below
Adult Cephalic	✓	✓	✓		See Below
Cardiac Adult	✓	✓	✓	✓	See Below
Cardiac Pediatric	✓	✓	✓	✓	See Below
Transesophageal
Isrectal	✓	✓	✓		See Below
Transvaginal	✓	✓	✓		See Below
Transuretheral
Intraluminal
Peripheral Vessel	✓	✓	✓	✓	See Below
Laparoscopic	✓	✓	✓		See Below

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

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

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Qirist A. Beyermann
(Division Sign-Off)

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

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

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

unknown at submission ASU-35WL-10

K972465

Fill our one form for each ultrasound system and transducer

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

	MODES of OPERATION
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Opthalmic
Fetal
Abdominal
Intra-Operative
Intra-Operative
Neurological
Pediatric
Small Organ		✓	✓						B/M
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
asrectal
ransvaginal
Transuretheral
Intraluminal
Peripheral Vessel
Laparoscopic

Other Indications or Modes:

Small Organ Applications:

Breast, Testes, Thyroid

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

Thind A. Segerom

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

Radiological Devices
510(k) Number K972465

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

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

unknown at submission ASU-66

(972465

Fill our one form for each ultrasound system and transducer

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

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

Other Indications or Modes:

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

David A. Keyram
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, Ind Radiclogical Devices

10(k) Number K472465

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

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

K972465

Fill our one form for each ultrasound system and transducer

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

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	CVI	Combined	Other
Opthalmic
Fetal
Abdominal
Intra-Operative
Intra-Operative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac Adult					✓
Cardiac Pediatric					✓
(Transesophageal/Transrectal)
Transvaginal
Transuretheral
Intraluminal
Peripheral Vessel					✓
Laparoscopic

Other Indications or Modes:

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

David G. Seegborn

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

510(k) Number K972465

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

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

unknown at submission UST-5524-7.5

972465

Fill our one form for each ultrasound system and transducer

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

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

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

Small Organ Applications:

Breast, Testes, Thyroid

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

Prescription Use (Per 21 CFR 801.109)

David A. Heymann

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

510(k) Number K112465

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

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

unknown at submission UST-5536-7.5 Transducer

K972465

Fill our one form for each ultrasound system and transducer

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

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

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

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

Concurrence of CDRH, Office of Device Evaluatition (ODE)

Cilvin C. Eggert

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

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

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

{

unknown at submission UST-579T-7.5

<972465

Fill our one form for each ultrasound system and transducer

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

	MODES of OPERATION
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Opthalmic
Fetal
Abdominal
Intra-Operative		✓	✓	✓					See Below
Intra-OperativeNeurological
Pediatric
Small Organ		✓	✓	✓					See Below
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
nsrectal
transvaginal
Transuretheral
Intraluminal
Peripheral Vessel		✓	✓	✓					See Below
Laparoscopic

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

Intraoperative Applications: Small Organ Applications:

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

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

Claird Ch. de yorm

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

510(k) Number K972465

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

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

unknown at submission UST-672-517.5

K972465

Fill our one form for each ultrasound system and transducer

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

	MODES of OPERATION
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Ophthalmic
Fetal
Abdominal		✓	✓	✓
Intra-Operative		✓	✓	✓					See Below
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
nsrectal		✓	✓	✓					See Below
Transvaginal
Transuretheral
Intraluminal
Peripheral Vessel
Laparoscopic

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

Intraoperative Applications:

Abdominal (such as liver, pancreas, gall bladder)

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

Concurrence of CDRH, Office of Device Evaluatition (ODE)

David C. Beynon
(Division Sign-off)

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

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

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

unknown at submission UST-670P-5

K972465

Fill our one form for each ultrasound system and transducer

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

ClinicalApplication	MODES of OPERATION
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Opthalmic
Fetal
Abdominal
Intra-Operative
Intra-Operative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
insrectal		✓	✓	✓					See Below
Transvaginal
Transuretheral
Intraluminal
Peripheral Vessel
Laparoscopic

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

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

David A. Bergman

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

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

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

unknown at submission UST-979-3.5

K972465

Fill our one form for each ultrasound system and transducer

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

	MODES of OPERATION
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Opthalmic
Fetal		✓	✓	✓					See Below
Abdominal		✓	✓	✓					See Below
Intra-Operative
Intra-OperativeNeurological
Pediatric		✓	✓	✓					See Below
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
insrectal
transvaginal
Transuretheral
Intraluminal
Peripheral Vessel
Laparoscopic

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

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

David A. Seymin

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

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

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

unknown at submission UST-984P-5

K972465

Fill our one form for each ultrasound system and transducer

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

	MODES of OPERATION
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Opthalmic
Fetal		✓	✓	✓					See Below
Abdominal
Intra-Operative
Intra-OperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
ansrectal
transvaginal		✓	✓	✓					See Below
Transuretheral
Intraluminal
Peripheral Vessel
Laparoscopic

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

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

David A. Jessop

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

510(k) Number K972469

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

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

unknown at submission UST-987-7.5

K972465

Fill our one form for each ultrasound system and transducer

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

	MODES of OPERATION
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Opthalmic
Fetal
Abdominal
Intra-Operative		✓	✓	✓					See Below
Intra-OperativeNeurological		✓	✓	✓					See Below
Pediatric
Small Organ		✓	✓	✓					See Below
Neonatal Cephalic		✓	✓	✓					See Below
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraluminal
Peripheral Vessel
Laparoscopic

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

Intraoperative Applications: Small Organ Applications:

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

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

David C. Seymour
(Division Sign-Off)

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

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

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

unknown at submission UST-995-7.5

1972465

Fill our one form for each ultrasound system and transducer

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

	MODES of OPERATION
Clinical	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Application
Opthalmic
Fetal
Abdominal
Intra-Operative		✓	✓	✓					See Below
Intra-OperativeNeurological
Pediatric
Small Organ		✓	✓	✓					See Below
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
(transrectal
transvaginal
Transuretheral
Intraluminal
Peripheral Vessel		✓	✓	✓					See Below
Laparoscopic

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

Intraoperative Applications:

Abdominal (such as liver, pancreas, gall bladder)

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

Concurrence of CDRH, Office of Device Evaluatition (ODE)

David A. Segerson

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

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.