Predicate Devices

K900805, K880900, K983879, K002003, K974269, K961459

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes replacement ultrasound transducers and does not mention AI or ML capabilities.

Therapeutic

No
The device is described as being for "diagnostic ultrasound imaging or fluid flow analysis," which indicates it is used for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the transducer assemblies are "intended for use... in diagnostic ultrasound imaging or fluid flow analysis." The listed specific indications of use also relate to anatomical sites for diagnostic imaging.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of physical components like piezoelectric crystals, an acoustic lens, a scan head, a cable, and a connector, which are hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The intended use of these ultrasound transducers is for "diagnostic ultrasound imaging or fluid flow analysis of the human body." This involves imaging the body directly, not analyzing samples taken from the body (like blood, urine, tissue, etc.).
The device description confirms it's a component for ultrasound imaging. It describes the physical parts of the transducer used to generate and receive ultrasound waves for imaging.
The indications for use are related to imaging specific anatomical sites. The table lists various body parts and systems that can be imaged with these transducers.

In summary, this device is a medical device used for in vivo (within the living body) diagnostic imaging, not in vitro (outside the living body) diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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:

AL3C34A: Abdominal, Fetal
AL7L50A: Small organ, Peripheral vascular
AL3C79B: Abdominal, Fetal, Pediatric
AL7L24B: Small organ, Peripheral vascular
AT3C42B: Abdominal, Fetal, Pediatric
AT3C52B: Abdominal, Fetal, Pediatric
AT5L40B: Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal
AT3P32A: Abdominal, Adult cephalic, Cardiac
AT3P42A: Abdominal, Adult cephalic, Cardiac

Product codes (comma separated list FDA assigned to the subject device)

90ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Fetal, Small organ, Peripheral vascular, Pediatric, Adult cephalic, Cardiac, Musculo-skeletal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K900805, K880900, K983879, K002003, K974269, K961459

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 Corporation
5F, No. 31, Shintai Road
Jupei City, Hsinchu 30252, Taiwan
Tel: 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, AL7L24B
AT3C42B, AT3C52B, AT5L40B, AT3P32A, AT3P42A
Common Name:	Diagnostic Ultrasound Transducer Assembly,
Ultrasound Imaging Probe,
Medical Ultrasound Probe, or
Diagnostic Ultrasound Probe
Classification Name:	Transducer, Ultrasonic, Diagnostic
Classification Regulation:	21 CRF 892.1570
Product Code:	90ITX
Class:	II

S10(k) Number: K070195

1

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 New
Replacement Model | Predicate OEM
Transducer 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:

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

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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.

4

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

5

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

6

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)

7

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, or
Diagnostic 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	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		P	P				Note 1
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 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	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)

(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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		P	P	P		Color
Doppler	P		Note 1
Intraoperative
(specify)
Pediatric		P	P	P		Color
Doppler	P		Note 1
Small Organ
(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		Color
Doppler			Note 1
Laparoscopic
Musculo-skeletal		P	P	P		Color
Doppler			Note 1
Conventional
Musculo-skeletal
Superficial		P	P	P		Color
Doppler
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	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	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)

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