The device is intended for use by a qualified physician for ultrasound evaluation of Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal applications. The device is not indicated for Ophthalmic applications.

Device Description

The Aloka Prosound 2 Diagnostic Ultrasound System is a light weight, full-digital portable imaging and analysis system. It consist of a high resolution LCD flat panel monitor that provides excellent image quality and processing. The user interface includes a computer type keyboard. specialized controls and a display.

AI/ML Overview

The provided 510(k) summary for the Aloka Prosound 2 Diagnostic Ultrasound System states "Clinical Tests: None Required." Therefore, there is no study presented in this document that proves the device meets specific acceptance criteria based on clinical performance.

The submission focuses on demonstrating substantial equivalence to a predicate device (Aloka SSD-500, K900805) and other cleared Aloka systems. Substantial equivalence relies on comparing the technological characteristics, safety, effectiveness features, and intended uses of the new device to a legally marketed predicate. In this context, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since no clinical studies were performed to establish performance against specific acceptance criteria, this table cannot be directly populated from the provided information. Instead, the acceptance criteria are implicitly that the device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that it conforms to applicable medical device safety standards.

Acceptance Criteria (Implicit from Substantial Equivalence Determination)	Reported Device Performance
Technically comparable to predicate device	Stated as "technically comparable and substantially equivalent" to Aloka SSD-500 (K900805).
Same technological characteristics as predicate device	Stated as having "the same technological characteristics" as the predicate device.
Key safety and effectiveness features are the same as predicate device	Stated as having "the same technological characteristics, key safety and effectiveness features" as the predicate device.
Same intended uses and basic operating modes as predicate device	Stated as having "the same intended uses and basic operating modes" as the predicate device.
Compliance with applicable medical device safety standards	"Device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards." Quality systems conform to 21 CFR 820, ISO 9001:2000, and ISO 13485.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical tests or test sets were used for performance evaluation as part of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical tests or ground truth establishment by experts were described in this 510(k) summary.

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

Not applicable, as no clinical tests or adjudication methods were described in this 510(k) summary.

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

Not applicable, as this is an ultrasound imaging device, not an AI-assisted diagnostic tool, and no MRMC study was conducted or mentioned.

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

Not applicable, as this is an ultrasound imaging device, not an algorithm that performs standalone analysis.

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

Not applicable, as no clinical tests requiring ground truth were conducted for this 510(k) submission. The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set

Not applicable, as there is no mention of a training set for an algorithm. The device's design and development conform to quality systems rather than a data-driven training process for an AI.

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

Not applicable, as there is no mention of a training set or its ground truth.

Summary

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510(K)

KCJ3254

DEC 1 9 2008

510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92

Section a): 1. Submitter: Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 Richard J. Cehovsky, RA/QA Coordinator, Contact Person: Tel: (203)269-5088 Ext. 346, Fax: 203-269-6075 Date Prepared: 9/18/08 2. Device Name: Aloka Prosound 2 Diagnostic Ultrasound System Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYN Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO Aloka SSD-500 Diagnostic Ultrasound System K900805, (90-IYN, ITX, IYO) 3. Marketed Device: ( A device currently in commercial distribution) 4. Device Description: The Aloka Prosound 2 Diagnostic Ultrasound System is a light weight, full-digital portable imaging and analysis system. It consist of a high resolution LCD flat panel monitor that provides excellent image quality and processing . The user interface includes a computer type keyboard. specialized controls and a display. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of 5. Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intraoperative, Transrectal and Abdominal applications. The device is not indicated for Ophthalmic applications. 6.Comparison w/ Predicate Device: The Aloka Prosound 2 is technically comparable and substantially equivalent to the current Aloka SSD-500-(K900805). It has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate device. Section b): 1. Non-clinical Tests: The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards. 2. Clinical Tests: None Required. 3. Conclusion: Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka Prosound 2 Diagnostic Ultrasound System and its transducers are substantially equivalent with respect

to safety and effectiveness to its predicate and other currently cleared Aloka systems.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

000 2 2 2009

Aloka Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K083254

Trade/Device Name: Aloka Prosound 2 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 2, 2008 Received: December 4, 2008

Dear Mr. Borsai:

This letter corrects our substantially equivalent letter of December 19, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Aloka Prosound 2, as described in your premarket notification:

Transducer Model Number

UST-5561-7.5	UST-660-7.5
UST-556T-7.5	UST-934N-3.5
UST-556TU-7.5	UST-935N-5
UST-586-5	UST-944B-3.5
UST587I-5	UST-945B-5

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

UST-974-5	UST-5711
UST-981-5	UST-5820-5
UST-5512U-7.5	UST-9111-5
UST-5551	UST-9137

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.

Sincerely yours,

Harald Lemke

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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119 ·

Section 1.3 Indications for Use

Section 1.3.1

510(k) Indications for Use Statement/Forms

( Immediately follows this page)

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

Indications for Use

510(K) Number (if known):

Device Name:

Aloka Prosound 2

Indications For Use:

The device is not indicated for Ophthalmic applications.

Prescription Use P (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hertenn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 8355 510(k) Number

Page 1 of 1

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1.3.1

Diagnostic Ultrasound Indications for Use Form Prosound 2

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)
Opthalmic
Fetal		N	N						See Below
Abdominal		N	N						See Below
Intraoperative (specify)		N	N						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		N	N						See Below
Neonatal Cephalic		N	N						See Below
Adult Cephalic
Cardiac		N	N						See Below
Transesophageal
Transrectal		N	N						See Below
Transvaginal		N	N						See Below
Transurethral
Intravascular
Peripheral Vascular		N	N						See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		N	N						See Below

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

Additional Comments: Mixed mode operation includes- BM

Applications: Small Parts-(breast, testes & thyroid), abdominal, gynecological-fetal, neonatal cephalic,

transrectal, transvaginal, cardiac, intra-operative-(liver, pancreas, gall bladder, etc.), peripheral vascular.

(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)

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

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

・

Diagnostic Ultrasound Indications for Use Form UST-5561-7.5 (K840540)

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)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)

IE 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)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Radiological Devices 2018 3 255

AAA

・

. .

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

Diagnostic Ultrasound Indications for Use Form UST-556T-7.5 (K840540)

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)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other:

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

Additional Comments: Mixed mode operation includes- B/M

Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)

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)

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

Radiological Devices

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form UST-556TU-7.5

(K870916)

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)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Herl Rem

(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 083254 510(k) Number _

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

Diagnostic Ultrasound Indications for Use Form UST-586-5 (K861538)

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)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		N	N						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

Applications: Small Parts- (breasts, tests, thyroid, etc.)

(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)

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

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

Diagnostic Ultrasound Indications for Use Form UST-5871-5 (K840540)

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)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)

(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)

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

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

Diagnostic Ultrasound Indications for Use Form UST-660-7.5 (K870916)

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)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P						See Below
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

(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)

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

. .

ann

i 27

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

Diagnostic Ultrasound Indications for Use Form UST-934N-3.5 (K900805)

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)
Opthalmic
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
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		P	P						See Below

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

Additional Comments: Mixed mode operation includes- B/M

(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)

(Division Sign-Off)

Division of Reproductive, Abdominal and

Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form UST-935N-5 (K900805)

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)
Opthalmic
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
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		P	P						See Below

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

Additional Comments: Mixed mode operation includes- B/M

(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)

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

Radiological Devices

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form UST-944B-3.5 (K870916)

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)
Opthalmic
Fetal
Abdominal		P	P						See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P						See Below
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

(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)

Ted Kens

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

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

Diagnostic Ultrasound Indications for Use Form UST-945B-5 (K900805)

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)
Opthalmic
Fetal		P	P						See Below
Abdominal
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-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		P	P						See Below

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

Additional Comments: Mixed mode operation includes- B/M

(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)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083254

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

Diagnostic Ultrasound Indications for Use Form UST-974-5 (K910153)

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

Clinical Application	B	M	Color Velocity Imaging
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic	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

(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)

Heubolem

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

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

. . .

: ·

Diagnostic Ultrasound Indications for Use Form UST-981-5 (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		N	N						See Below
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		N	N						See Below
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		N	N						See Below

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

Additional Comments: Mixed mode operation includes- B/M

(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)

Prescripti

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 083254 510(k) Number

・

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

Diagnostic Ultrasound Indications for Use Form UST-5512U-7.5 (K861538)

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)
Opthalmic
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-skeletalConventional
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

Applications: Small Parts- (breasts, tests, thyroid, etc.)

(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)

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

. . . .

ર્સ્વ

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

1 35

Diagnostic Ultrasound Indications for Use Form UST-5551 (K861538)

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)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		N	N						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

Applications: Small Parts- (breasts, tests, thyroid, etc.)

(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)

Hetlew

(Division Sign-Off)

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

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

. .

Diagnostic Ultrasound Indications for Use Form UST-5711 (K861538)

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	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		N	N						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N						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

Applications: Small Parts- (breasts, tests, thyroid, etc.)

(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)

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

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

Diagnostic Ultrasound Indications for Use Form UST-5820-5 (K840540)

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)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		N	N						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)		N	N						See Below
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

Applications: Small Parts- (breasts, tests, thyroid, etc.)

(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)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083254

. . .

રત

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

Diagnostic Ultrasound Indications for Use Form UST-9111-5 (K910153)

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)		N	N						See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		N	N						See Below
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
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

Applications: Intra-Operative- (Liver, pancreas, gall Bladder)

(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)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices,
510(k) Number K083254

રેસ

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

Diagnostic Ultrasound Indications for Use Form UST-9137 (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	Color.VelocityImaging	Combined(specify)
Opthalmic
Fetal		N	N						See Below
Abdominal		N	N						See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		N	N						See Below

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

Additional Comments: Mixed mode operation includes- B/M

(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)

Heleum

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

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

ાપ્ય છે

1.3.2 New Indications for Use: There are no new indications for use.

1.3.3 Previously Cleared Indications for Use:

The Prosound 2 diagnostic ultrasound system and its transducers are intended for use in diagnostic ultrasound examinations. These ultrasound applications for use include: Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal applications.

The Prosound 2 has the same indications for use as its predicate - Aloka SSD-500 (K910153) and other market cleared systems and transducers manufactured by Aloka.

Promotional information for the Prosound 2 is provided in Appendix D of this submission.

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.