The above referenced Broadsound transducer assemblies are intended for use, with standard ultrasound systems, in diagnostic ultrasound imaging or fluid flow analysis of the human body and to be operated by or under the direction of a physician.

Their specific indications for use are listed as following:

	Model Name	Specific Indications of Use*
1	AL3C34A	Abdominal, Fetal
2	AL7L50A	Small organ, Peripheral vascular
3	AL3C79B	Abdominal, Fetal, Pediatric
4	AL7L24B	Small organ, Peripheral vascular
5	AT3C42B	Abdominal, Fetal, Pediatric
6	AT3C52B	Abdominal, Fetal, Pediatric
7	AT5L40B	Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal
8	AT3P32A	Abdominal, Adult cephalic, Cardiac
9	AT3P42A	Abdominal, Adult cephalic, Cardiac

Device Description

The above referenced devices are replacement ultrasound transducers used with standard ultrasound systems. Each of them consists of piezoelectric crystals covered with an acoustic lens, a scan head that fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.

AI/ML Overview

This document describes the 510(k) summary for Broadsound Corporation's diagnostic ultrasound transducer assemblies. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo performance criteria. Therefore, the information provided relates to equivalence criteria and comparative testing against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here is "substantial equivalence" to predicate devices. The reported device performance is that the Broadsound transducers are "statistically comparable" to their corresponding predicate devices in terms of acoustic output and general performance.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Similar in features and use parameters to predicate devices. Used on the same diagnostic ultrasound systems. No new technology employed. Compliance with electrical, mechanical, thermal, and biocompatible safety standards. Acoustic output statistically comparable to predicate.	Broadsound transducers are "very similar to [their corresponding predicate device] in terms of features and use parameters."
		"used on the same diagnostic ultrasound systems."
		"No new technology is employed on these devices."
	Electrical, Mechanical, thermal, and biocompatible safety testing conducted.	"the results are included in the submission." (Implying compliance)
	Acoustic output and general performance comparable to predicate devices.	"acoustic output and found statistically comparable to each other." "Performance testing was also conducted and included in the submission."

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

The document does not specify the exact sample size for the test set used for performance testing. It states that "Each of above referenced ultrasound transducer assemblies and its corresponding predicate device were tested," which implies a comparison of individual units of each Broadsound model against individual units of its corresponding predicate model.

The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin of the data. However, the manufacturer is in Taiwan, so it is likely the testing was conducted there or arranged by the manufacturer.

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

This submission is for an ultrasound transducer assembly, not a diagnostic algorithm that requires expert interpretation of images for ground truth. Therefore, the concept of "experts" to establish ground truth in the context of image interpretation is not applicable here. The evaluation focuses on the physical and functional performance of the device against established predicate devices and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving human interpretation with adjudication. The performance testing is based on objective measurements of device characteristics and comparison to predicate devices and safety standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a premarket notification for a medical device (ultrasound transducer) demonstrating substantial equivalence to existing devices, not a comparative effectiveness study involving human readers and AI for diagnostic improvement.

6. Standalone (Algorithm Only) Performance Study

No, this is about hardware (ultrasound transducers) and their performance characteristics. It does not involve any algorithms in a standalone performance study as described in AI/ML performance evaluations.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established technical specifications, safety standards, and the performance characteristics of the predicate ultrasound transducers. The Broadsound devices are compared against these benchmarks, rather than against expert consensus, pathology, or outcomes data which are typically used for diagnostic accuracy studies. The ground truth for this submission would involve:

Predicate Device Specifications: The technical and performance characteristics of the legally marketed predicate ultrasound transducers.
Safety Standards: Established electrical, mechanical, thermal, and biocompatibility safety standards for medical devices.
Acoustic Output Measurements: Standardized measurements of acoustic power and intensity.

8. Sample Size for the Training Set

Not applicable. This submission is for hardware (ultrasound transducers) and does not involve a "training set" in the context of machine learning or AI models.

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

Not applicable, as there is no training set for this type of device submission.

Summary

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D9. 1 of 4
Section S
$101) Surmeи y у
PAGE 1 of 13 PAGES

OCT 1 5 2007

510(k) Summary

For BRODASOUND Model AL3C34A, AL7L50A, AL3C79B, AL7L24B, AT3C42B, AT3C52B, AT5L40B, AT3P32A, and AT3P42A Diagnostic Ultrasound Transducer Assemblies

510(k) Number:	K070195
Submitter:	Broadsound Corporation5F, No. 31, Shintai RoadJupei City, Hsinchu 30252, TaiwanTel: 886-3-5539868, Fax: 886-3-5539808
Contact Person:	Jiann-Hwa Jeng, Ph.D., President & CEO
Date Prepared:	August 30, 2007
Device Name:Trade Name:	BROADSOUND
Model Name:	AL3C34A, AL7L50A, AL3C79B, AL7L24BAT3C42B, AT3C52B, AT5L40B, AT3P32A, AT3P42A
Common Name:	Diagnostic Ultrasound Transducer Assembly,Ultrasound Imaging Probe,Medical Ultrasound Probe, orDiagnostic Ultrasound Probe
Classification Name:	Transducer, Ultrasonic, Diagnostic
Classification Regulation:	21 CRF 892.1570
Product Code:	90ITX
Class:	II

S10(k) Number: K070195

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K070195
pg. 2 of 4

5 HQ(la Summary PAGE Car H FAKES

Device Comparison:

Legally marketed devices for substantial equivalence comparison are listed as following:

Subject Device	510(k) Number	Model Name	Manufacturer
AL3C34A	K900805, K880900	UST-934N-3.5	Aloka Ltd.
AL7L50A	K900805, K880900	UST-5512U-7.5	Aloka Ltd.
AL3C79B	K983879	UST-979-3.5	Aloka Ltd.
AL7L24B	K983879	UST-5524-7.5	Aloka Ltd.
AT3C42B	K002003	C5-2	ATL Ultrasound Inc.
	Marketed product	C4-2	ATL Ultrasound Inc.
AT3C52B	K002003	C5-2	ATL Ultrasound Inc.
AT5L40B	K002003	L7-4	ATL Ultrasound Inc.
AT3P32A	K974269, K961459	Medison P4-2	Medison America, Inc.
	Marketed product	ATL P3-2	ATL Ultrasound Inc.
AT3P42A	K974269, K961459	Medison P4-2	Medison America, Inc.
	Marketed product	ATL P4-2	ATL Ultrasound Inc.

Each of above referenced transducer assemblies is substantially equivalent to its corresponding predicate device, and both of them are very similar to each other in terms of features and use parameters; as well, they are used on the same diagnostic ultrasound systems.

Legally marketed devices that Broadsound replacement transducers are intended to replace with are summarized as following:

Broadsound NewReplacement Model	Predicate OEMTransducer Model	Indicated System
AL3C34A	Aloka UST-934N-3.5	Aloka SSD-500
AL7L50A	Aloka UST-5512U-7.5	Aloka SSD-500
AL3C79B	Aloka UST-979-3.5	Aloka SSD-900
AL7L24B	Aloka UST-5524-7.5	Aloka SSD-900
AT3C42B	ATL C4-2	ATL HDI 5000
AT3C52B	ATL C5-2	ATL HDI 5000
AT5L40B	ATL L7-4	ATL HDI 5000
AT3P32A	ATL P3-2	ATL HDI 5000
AT3P42A	ATL P4-2	ATL HDI 5000

Description of Devices:

The above referenced devices are replacement ultrasound transducers used with standard ultrasound Each of them consists of piezoelectric crystals covered with an acoustic lens, a scan head systems. that fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.

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K070195
pg. 3 of 4

Section 510(k) Summary 彩金彩金 4 01 13 PAGES

Specification	AL3C34A	AL7L50A	AL3C79B	AL7L24B
Frequency range	5-2 MHz	10-5 MHz	5-2 MHz	10-5 MHz
Array type	Convex	Linear	Convex	Linear
Field of view	60 degree	38 mm	70 degree	42 mm
Element number	72	72	120	120
Pitch	1.0 mm	0.6 mm	0.6 mm	0.375 mm

The specifications of each transducer assembly are listed as following:

Specification	AT3C42B	AT3C52B	AT5L40B	AT3P32A	AT3P42A
Frequency range	4-2 MHz	5-2 MHz	7-4 MHz	3-2 MHz	4-2 MHz
Array type	Convex	Convex	Linear	Phased	Phased
Field of view	75 degree	75 degree	40 mm	90 degree	90 degree
Element number	128	128	128	64	64
Pitch	0.4 mm	0.4 mm	0.6 mm	0.32 mm	0.32 mm

Intended Use:

Their specific indications for use are listed as following:

	Model Name	Specific Indications of Use*
1	AL3C34A	Abdominal, Fetal
2	AL7L50A	Small organ, Peripheral vascular
3	AL3C79B	Abdominal, Fetal, Pediatric
4	AL7L24B	Small organ, Peripheral vascular
5	AT3C42B	Abdominal, Fetal, Pediatric
6	AT3C52B	Abdominal, Fetal, Pediatric
7	AT5L40B	Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal
8	AT3P32A	Abdominal, Adult cephalic, Cardiac
9	AT3P42A	Abdominal, Adult cephalic, Cardiac

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K070195
pg-Hof 4

3 (A) (2) 3 (2) (2007) (2007) PAGE of 13 CAGE

Characteristics of Technology:

Each of above referenced Broadsound transducer assemblies is substantially equivalent to its corresponding predicate device, and both of them are very similar to each other in terms of features and use parameters; as well, they are used on the same diagnostic ultrasound systems. No new technology is employed on these devices.

Safety Testing:

Electrical, Mechanical, thermal, and biocompatible safety testing were conducted on these devices; the results are included in the submission.

Performance Testing:

Each of above referenced ultrasound transducer assemblies and its corresponding predicate device were tested for acoustic output and found statistically comparable to each other. Performance testing was also conducted and included in the submission. -

CE Mark:

All above referenced devices have been granted CE0197 mark of European Union by TÜV Rheinland Product Safety GmbH, Germany since April 2006, and the pertinent information is included in the submission.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2007

Jiann-Hwa Jeng, Ph.D. President & CEO Broadsound Corporation 5F, No.31, Shintai Road JUPEI CITY HSINCHU 30252 TAIWAN

Re: K070195

Trade/Device Name: BROADSOUND Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: August 31, 2007 Received: September 4, 2007

Dear Dr. Jeng:

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 BROADSOUND, as described in your premarket notification:

Transducer Model Number
and and the first and the first of the first of the American American American	I

AL3C34A	AT3C52B
AL7L50A	AT5L40B
AL3C79B	AT3P32A
AL7L24B	AT3P42A
AT3C42B

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Page 2 - Dr. Jeng

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to 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 prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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

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Page 3 – Dr. Jeng

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

Sincerely yours,

Jouyi Tri Whang

for 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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Section 4 Indications For Use Statement PAGE: 1 of 1 PAGES

Indications For Use Statement

510(k) Number:	K070195
Common Name:	Diagnostic Ultrasound Transducer Assembly,Ultrasound Imaging Probe,Medical Ultrasound Probe, orDiagnostic Ultrasound Probe
Device Name
Trade Name:	BROADSOUND
Model Name:	AL3C34A, AL7L50A, AL3C79B, AL7L24B,AT3C42B, AT3C52B, AT5L40B, AT3P32A, AT3P42A

The above referenced devices are replacement ultrasound transducers intended to be used with standard ultrasound systems in diagnostic ultrasound imaging or fluid flow analysis of the human body and to be operated by or under the direction of a physician.

Their specific indications for use are listed as following:

	Model Name	Specific Indications of Use*
1	AL3C34A	Abdominal, Fetal
2	AL7L50A	Small organ, Peripheral vascular
3	AL3C79B	Abdominal, Fetal, Pediatric
4	AL7L24B	Small organ, Peripheral vascular
5	AT3C42B	Abdominal, Fetal, Pediatric
6	AT3C52B	Abdominal, Fetal, Pediatric
7	AT5L40B	Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal
8	AT3P32A	Abdominal, Adult cephalic, Cardiac
9	AT3P42A	Abdominal, Adult cephalic, Cardiac

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part21 CFR801 Subpart D)

(Division Sign-Off)

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

Over-The-Counter Use _ (Part21 CFR801 Subpart C)

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

510(K) Number (if known): K070195 Device Name (transducer): BROADSOUND AL3C34A Ultrasound System: Aloka SSD 500 series

Indications for Use:

Diagnostic ultrasound imaging 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)
Ophthalmic
Fetal		P	P						Note 1
Abdominal		P	P						Note 1
Intraoperative (specify)
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA under K900805 and K88090; E = added under Appendix E Note 1: Combined application includes B/M mode.

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

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

Section 5 510(k) Summary PAGE 6 of 13 PAGES

Diagnostic Ultrasound Indications for Use Form

510(K) Number (if known):	K070195
Device Name (transducer):	BROADSOUND AL7L50A
Ultrasound System:	Aloka SSD 500 series

Indications for Use:

Aloka SSD 500 series

Diagnostic ultrasound imaging 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
Intraoperative(specify)
Pediatric
Small Organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P						Note 1
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA under K900805 and K88090; E = added under Appendix E Note 1: Combined application includes B/M mode.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Wha
(Division Sign-Off)

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

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

510(K) Number (if known):
Device Name (transducer):
Ultrasound System:

K070195 BROADSOUND AL3C79B Aloka SSD 900 series

Indications for Use:

Diagnostic ultrasound imaging 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		P	P						Note 1
Abdominal		P	P						Note 1
Intraoperative(specify)
Pediatric		P	P						Note 1
Small Organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA under K983879; E = added under Appendix E

Note 1: Combined application includes B/M mode.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)

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

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

Section 5 510(k) Summary PAGE 8 of 13 PAGES

Diagnostic Ultrasound Indications for Use Form

510(K) Number (if known): K070195 Device Name (transducer): BROADSOUND AL7L24B Ultrasound System: Aloka SSD 900 series

Indications for Use: Diagnostic ultrasound imaging 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
Intraoperative(specify)
Pediatric
Small Organ(specify)		P	P						Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P						Note 1
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA under K983879; E = added under Appendix E

Note 1: Combined application includes B/M mode.

Small organ applications: Breast, Testes, Thyroid

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

louis Whan
(Divided Ben. Off)

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

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

510(K) Number (if known): Device Name (transducer): Ultrasound System:

K070195 BROADSOUND AT3C42B ATL HDI 5000 series

Indications for 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)
Ophthalmic
Fetal		P	P	P		P	P		Note 1
Abdominal		P	P	P		P	P		Note 2
Intraoperative (specify)
Pediatric		P	P	P		P	P		Note 2
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA under K002003; E = added under Appendix E Note 1: Combined application includes B/M mode.

Note 2: Combined applications include B/M, PWD/Color Doppler, and PWD/ Power Doppler modes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Tony M. White

ctive. Abdomin Badiolo 510(k) Num

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

510(K) Number (if known): K070195 Device Name (transducer): Ultrasound System:

Indications for Use:

BROADSOUND AT3C52B ATL HDI 5000 series

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		P	P	P		P	P		Note 1
Abdominal		P	P	P		P	P		Note 2
Intraoperative(specify)
Pediatric		P	P	P		P	P		Note 2
Small Organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA under K002003; E = added under Appendix E Note 1: Combined application includes B/M mode.

Note 2: Combined applications include B/M, PWD/Color Doppler, and PWD/ Power Doppler modes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

/Prescription Use
(Per 21 CFR 801.109)

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

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

510(K) Number (if known): K070195 Device Name (transducer): BROADSOUND AT5L40B Ultrasound System: ATL HDI 5000 series

Indications for 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		P	P	P		ColorDoppler	P		Note 1
Intraoperative(specify)
Pediatric		P	P	P		ColorDoppler	P		Note 1
Small Organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		ColorDoppler			Note 1
Laparoscopic
Musculo-skeletal		P	P	P		ColorDoppler			Note 1
Conventional
Musculo-skeletalSuperficial		P	P	P		ColorDoppler
Other (specify)

N = new indication; P = previously cleared by FDA under K002003; E = added under Appendix E Note 1: Combined applications include B/M, PWD/Color Doppler, and PWD/ Power Doppler modes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Vorge 7. Wh
(Division Sign-Off)

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

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

510(K) Number (if known): K070195 Device Name (transducer): Ultrasound System: ATL HDI 5000 series

Indications for Use:

BROADSOUND AT3P32A

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

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)
Ophthalmic
Fetal	P	P	P		P	P	Note 1
Abdominal	P	P	P	P	P	P	Note 2
Intraoperative (specify)
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	Note 2
Cardiac	P	P	P	P	P	P	Note 2
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

N = new indication; P = previously cleared by FDA under K974269 & K961459; E = added under Appendix E Note 1: Combined application includes B/M mode.

Note 2: Combined applications include PWD/Color Doppler and PWD/ Power Doppler modes..

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)

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

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

510(K) Number (if known): K070195 Device Name (transducer): BROADSOUND AT3P42A Ultrasound System: ATL HDI 5000 series

Indications for 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		P	P	P		P	P		Note 1
Abdominal		P	P	P	P	P	P		Note 2
Intraoperative
(specify)
Pediatric
Small Organ
(specify)
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		Note 2
Cardiac		P	P	P	P	P	P		Note 2
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA under K974269 & K961459; E = added under Appendix E Note 1: Combined application includes B/M mode.

Note 2: Combined applications include PWD/Color Doppler and PWD/ Power Doppler modes..

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Sign-Off) on of Reproductive, Abdominal, and cal Devices

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.