The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, pediatric, neonatal cephalic, musculoskeletal (general and superficial), Urology/Prostate and intraoperative (liver, gallbladder, pancreas).

Device Description

The DC-6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound mages in B-Mode. M-Mode. Color mode, PW mode, CW mode, Power/DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, phased array and convex array with a frequency range of approximately 2 MHz to 12 MHz. The modified DC-6 Diagnostic Ultrasound System also provides Smart3D imaging (Free hand 3D). iScape imaging (panoramic imaging) and Free Xros M imaging (anatomic M).

AI/ML Overview

The provided text describes a 510(k) summary for the Mindray DC-6 Diagnostic Ultrasound System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics or detailed study results against acceptance criteria in the typical sense of AI/ML device evaluations.

The document does not contain explicit acceptance criteria or a study design with reported device performance against those criteria in the context of an AI/ML algorithm evaluation. Instead, it refers to general safety and effectiveness.

However, I can extract information related to the device and its intended use, which can be framed in a table if we interpret "acceptance criteria" as the claimed functionalities and modes of operation for various clinical applications. The "reported device performance" would then be that these functionalities are present and effective (as implied by the declaration of substantial equivalence).

Here's an attempt to structure the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Claimed Functionality/Mode)	Reported Device Performance (Implied by Substantial Equivalence and Features)
Device operates in various modes for specific clinical applications (e.g., Fetal, Abdominal, Cardiac, Small organ, etc.)	The DC-6 Diagnostic Ultrasound System supports B-Mode, M-Mode, Color mode, PW mode, CW mode, Power/DirPower mode, and combined modes across a broad range of clinical applications. (Implied: these modes function as expected for diagnostic ultrasound imaging).
New imaging features (Smart3D, iScape, Free Xros M imaging)	The modified DC-6 Diagnostic Ultrasound System provides Smart3D imaging (Free hand 3D), iScape imaging (panoramic imaging), and Free Xros M imaging (anatomic M). (Implied: these features are correctly implemented and functional).
Acoustic output measurements	Measured and calculated per NEMA UD 2 (2004) and NEMA UD 3 standards. (Implied: device meets these standards).
Conformity to medical device safety standards	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1. (Implied: device meets these standards).
Substantial Equivalence to predicate devices	Conclusion: The device is as safe and effective as the legally marketed predicate devices.

Study Proving Device Meets Acceptance Criteria:

The document states: "The conclusions drawn from testing of the DC-6 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices."

This implies that the "study" conducted was primarily focused on demonstrating substantial equivalence to existing, legally marketed ultrasound systems. This typically involves:

Engineering and Performance Testing: Verifying that the technical specifications, acoustic output, image quality, and functionality of the new device are comparable to the predicate devices.
Compliance with Safety Standards: Demonstrating adherence to relevant national and international medical device safety standards (e.g., IEC, ISO, NEMA).
Clinical or Bench Testing (if required for specific aspects): While not explicitly detailed, comparisons for specific features or intended uses might have been performed to show equivalence. However, for a general diagnostic ultrasound system under a 510(k) pathway, extensive clinical performance studies demonstrating superiority or non-inferiority against a gold standard in a new clinical domain are often not required if substantial equivalence can be shown through technical and safety data.

Given the information, the answers to the specific questions are as follows:

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

The document does not specify a sample size for a test set in the context of an AI/ML algorithm or a clinical performance study. The evaluation method described is primarily through technical specifications comparisons and adherence to standards for substantial equivalence.
Data provenance is not mentioned; it's likely internal engineering and technical testing data rather than patient data from a specific country or study type.

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 / Not mentioned. The document does not describe a clinical study requiring expert ground truth for image interpretation or diagnosis. The assessment is an engineering and regulatory evaluation against predicate devices and standards.

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

Not applicable. No mention of an adjudication method, as there's no described clinical study involving multiple readers and a ground truth determination process.

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

No. The document does not mention any MRMC study or AI assistance. The device described is a general diagnostic ultrasound system, not an AI-powered diagnostic tool. The purpose is to show substantial equivalence of the hardware and core imaging functions.

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

No. This is not an AI/ML device, so no standalone algorithm performance evaluation would have been conducted or is mentioned.

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

Not applicable / Not mentioned. The evaluation focuses on technical performance and safety against engineering standards and comparison with predicate devices, not on diagnostic accuracy against a clinical ground truth like pathology for specific conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

Not applicable. As above, no training set or associated ground truth establishment is relevant to this device's submission.

Summary

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

510(K) SUMMARY Exhibit B

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is:

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: +86 755 2658 2888 Fax: +86 755 2658 2680

Contact Person:

Li Dongling Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan. Shenzhen. 518057, P. R. China

Date Prepared: Jun 21. 2007

2. Device Name: DC-6 Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892 1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Marketed Device:

The subject device is substantially equivalent in its technologies and functionality to the original DC-6 Diagnostic Ultrasound System that is already cleared under premarket notification number K063500 and other predicate devices noted below:

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

Predicate Device	Manufacturer	Model	510(k) Control Number
First	Toshiba	NEMIO SSA-550A	K010631
Second	Aloka	SSD-5000	K012080
Third	Philips	iU22	K042540
Fourth	Hewlett Packard	Sonos 5500	K990339
Fifth	Philips	HD11	K062247
Sixth	GE	Logiq 9	K061129

4. Device Description:

5. Intended Use:

6. Safety Considerations:

The DC-6 Diagnostic Ultrasound System has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 1997. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Output Display Standard. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-2. IEC 60601-2-37 and ISO 10993-1.

Conclusion:

The conclusions drawn from testing of the DC-6 Diagnostic Ultrasound System

PHATSIPERT DE LEBERT FREE MERKET PER TERRET DE PERSELLER PER LEGEN LE FART LE - JERDEREN LE

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

demonstrate that the device is as safe and effective as the legally marketed predicate devices.

ん - こ - 3 < 3 (3 0 0 0 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2

0047 , ::

September 19.

心 |

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle.

SEP - 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K072164

Trade Name: DC-6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN and ITX Dated: August 3, 2007 Received: August 6, 2007

Dear Mr. Mosenkis:

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 DC-6 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

$$\begin{array}{ll} \underline{\text{7L74}} \ \underline{\text{2P2}} \ \underline{\text{6L8}} \end{array} \tag{2.144} \ \begin{array}{ll} \underline{\text{6LE7}} \ \underline{\text{7L8}} \ \underline{\text{6C2}} \end{array} \tag{2.145}$$

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

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

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 (OS) 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

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

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

Sincerely yours,

Arpit MWhag sn NCB

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

System Model: × Transduccr DC-6

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic	P	P	P	P		P	P		P	Note 1, 2, 4
Fetal	P	P	P	P		P	P		P	Note 1, 2, 3,4
Intraoperative (specify)*	N	N	N	N		N	N		N	Note 2, 3, 4
Intraoperative Neurological
Pediatric	P	P	P	P		P	P		P	Note 1, 2, 3,4
Small organ(specify)*	P	P	P	P		P	P		P	Note 2, 3, 4
Neonatal Cephalic	P	P	P	P		P	P		P	Note 2, 3, 4
Adult Cephalic
Cardiac	P	P	P	N		P	P		P	Note 1, 4
Transesophageal
Transrectal	P	P	P	P		P	P		P	Note 2, 4
Transvaginal	P	P	P	P		P	P		P	Note 2, 4
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P		P	P		P	Note 2, 3, 4
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P		P	P		P	Note 2, 3, 4
Musculo-skeletal Superficial	P	P	P	P		P	P		P	Note 2, 3, 4
Other (specify) ***	N	N	N	N		N	N		N	Note 1, 2, 4
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Small organ-breast, thyroid, testes, etc.
** Intraoperative includes abdominal, thoracic, and vascular etc.
*** Other use includes Urology/Prostate.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Free Xros M imaging

(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)

JWhanx

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K072164 510(k) Number -

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

System

Model:

JUL 25 2007

510(k) Number(s)
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N	Note 2, 3, 4
Intraoperative (specify)*		N	N	N		N	N		N	Note 2, 3, 4
Intraoperative Neurological
Pediatric		N	N	N		N	N		N	Note 2, 3, 4
Small organ(specify) **		N	N	N		N	N		N	Note 2, 3, 4
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N	Note 2, 3, 4
Laparoscopic
Musculo-skeletal Conventional		N	N	N		N	N		N	Note 2, 3, 4
Musculo-skeletal Superficial		N	N	N		N	N		N	Note 2, 3, 4
Other (specify)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Small organ-breast, thyroid, testes, etc.
** Intraoperative includes abdominal, thoracic, and vascular etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Free Xros M imaging

Diagnostic Ultrasound Indications for Use Form

Transducer

7LT4

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancyc Sradon
(Division Sign-Off)

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

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

Mindray Co. Ltd. - DC-6 Diagnostic Ultrasound System

JUL 25 2007

Diagnostic Ultrasound Indications for Use Form

System Model:

510(k) Number(s)

Transducer × 2P2

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)"
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N	Note 1, 4
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (Urology)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW+B.
*Small organ-breast, thyroid, testes, etc.
** Intraoperative includes abdominal, thoracic, and vascular etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Free Xros M imaging

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

Nancy C.Bogdon
(Division Sign-Off)

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

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

Mindray Co. Ltd. - DC-6 Diagnostic Ultrasound System

JUL 25 2007

Diagnostic Ultrasound Indications for Use Form ×

Transducer

6LB7

System Model:

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		N	Note 2, 4
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)***		N	N	N		N	N		N	Note 2, 4
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Small organ-breast, thyroid, testes, etc.
** Intraoperative includes abdominal, thoracic, and vascular etc.
*** Other use includes Urology/Prostate.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Free Xros M imaging

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancy C. Boagdon

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

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

JUL 25 2007

System Model:

Transducer × 6LE7

510(k) Number(s)

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal		N	N	N		N	N		N	Note 2, 4
Abdominal		N	N	N		N	N		N	Note 2, 5
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		N	Note 2, 4
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify) ***		N	N	N		N	N		N	Note 2, 4
N=new indication; P=previously cleared by FDA; E=added under Appendix EAdditional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW+B.Small organ-breast, thyroid, testes, etc.* Intraoperative includes abdominal, thoracic, and vascular etc.*** Other use includes Urology.Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.Note 2: Smart3DNote 3: iScape

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

Nancy C. Brogdon
(Division Sign-Off)

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

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

Mindray Co. Ltd. - DC-6 Diagnostic Ultrasound System

JUL 25 2007

Diagnostic Ultrasound Indications for Use Form

System

Transducer メ

Model:

510(k) Number(s)

7L4A, 7L6, 10L4

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)*		E	E	E		E	E		E	Note 2, 3, 4
Neonatal Cephalic		E	E	E		E	E		E	Note 2, 3, 4
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		E	E	E		E	E		E	Note 2, 3, 4
Laparoscopic
Musculo-skeletal Conventional		E	E	E		E	E		E	Note 2, 3, 4
Musculo-skeletal Superficial		E	E	E		E	E		E	Note 2, 3, 4
Other (specify)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Small organ-breast, thyroid, testes, etc.
** Intraoperative includes abdominal, thoracic, and vascular etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Free Xros M imaging

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

Nancyc. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal and

Radiological Devices 510(k) Number

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

JUL 25 2007

System Model:

Transducer 6C2

510(k) Number(s)

—

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N	Note 2, 4
Intraoperative (specify)*
Intraoperative Neurological
Pediatric		N	N	N		N	N		N	Note 2, 4
Small organ(specify)**
Neonatal Cephalic		N	N	N		N	N		N	Note 2, 4
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Nancye Brogdon
(Division Sign-Off)

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

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

JUL 25 2007

System Model:

Transducer × 3CSA

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal		E	E	E		E	E		E	Note 1, 2, 4
Abdominal		E	E	E		E	E		E	Note 1, 2, 4
Intraoperative (specify)*
Intraoperative Neurological
Pediatric		N	N	N		N	N		N	Note 1, 2, 4
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (Urology)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B,
*Small organ-breast, thyroid, testes, etc.
** Intraoperative includes abdominal, thoracic, and vascular etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: Free Xros M imaging

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancy Brogdon

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

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.