The device is intended for use by a qualified physician for ultrasound evaluation of gynecology, obstetrics, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedial, and musculoskeletal, perficial vascular, exams exams.

Device Description

The DC-3/DC-3T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. It function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode, 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, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

AI/ML Overview

The provided document is a 510(k) summary for the Mindray DC-3/DC-3T Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.

Therefore, the document does not contain the following information:

A table of acceptance criteria and the reported device performance: The submission is for a general-purpose diagnostic ultrasound system, and its "performance" is demonstrated through its substantial equivalence to predicate devices, compliance with safety standards (e.g., acoustic output, electrical safety), and its ability to acquire and display various ultrasound modes. There are no specific quantitative performance metrics or acceptance criteria for a diagnostic algorithm provided.
Sample size used for the test set and the data provenance: No specific test set data is described for algorithmic performance. The indications for use are established based on the capabilities of the ultrasound system and its transducers, and their equivalence to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic algorithm requiring ground truth establishment for a test set described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as no AI model training is mentioned.
How the ground truth for the training set was established: Not applicable.

However, based on the document, here's what can be extracted:

Acceptance Criteria (Implied by the 510(k) process for ultrasound systems):

The implied acceptance criteria for this diagnostic ultrasound system are focused on demonstrating substantial equivalence to existing legally marketed predicate devices, along with compliance with relevant safety and performance standards. While not explicitly stated in a table with performance targets, the document indicates that the device meets these criteria through:

Technological Equivalence and Functionality: The device shares similar technologies and functionality with predicate devices.
Intended Use Equivalence: The device has the same intended uses as the predicate devices across various clinical applications and modes of operation.
Compliance with Safety Standards: Adherence to recognized medical device safety and acoustic output standards.

Study Proving Acceptance Criteria (General Description):

The "study" proving the device meets the acceptance criteria is the 510(k) premarket notification process itself, where the manufacturer (Shenzhen Mindray Bio-medical Electronics Co., LTD) demonstrates substantial equivalence. The summary states:

"The conclusions drawn from testing of the DC-3/DC-3T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices." (Page 2)

This demonstration of safety and effectiveness, leading to the FDA's substantial equivalence determination, relies on:

Comparison to Predicate Devices: The primary method is a direct comparison of the DC-3/DC-3T system's technological characteristics, intended use, and performance claims to those of its predicate devices:
- Original DC-3/DC-3T Diagnostic Ultrasound System (K083505)
- Mindray M5 (K080640)
- Mindray DC-6 (K072164)
- GE Voluson 730 (K041688)
Compliance with Recognized Standards:
- Acoustic Output: Measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Standards, such as IEC 6004.
- Medical Device Safety: Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.

Specific Information Found in the Document:

Device Type: General purpose, mobile, software-controlled diagnostic ultrasound system.
Operating Modes: B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode, or combined modes (e.g., B/M Mode, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B).
Probes: Linear array, convex array, and phased array.
Frequency Range: Approximately 2.0 MHz to 12.0 MHz.
Intended Use: Wide range of clinical applications including gynecology, obstetrics, abdominal, pediatric, small parts, neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal exams. The Indications for Use forms (pages 4-17) detail which transducers are indicated for which specific clinical applications and modes.

In summary, for this type of conventional diagnostic imaging device, the acceptance criteria are largely met by demonstrating adherence to established engineering, performance, and safety standards, and by showing that the device is equivalent in its intended use and fundamental technological characteristics to devices already on the market.

Summary

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

JUL - 9 2009

K091941

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §801 13 Donny

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, D. Cu 518057, P. R. China

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

Contact Person:

Tan Chuanbin 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: May 26, 2009

Device Name: DC-3/DC-3T Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-TYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-11

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-3/DC-3T Diagnostic Ultrasound System that is already cleared under premarket notification number K083505, and the other predicate devices are listed below: Mindray M5 (K080640), Mindray DC-6 (K072164),GE Voluson 730(K041688),

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

4. Device Description:

5. Intended Use:

6. Safety Considerations:

The DC-3/DC-3T 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 in September 2008. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Standards, such, as JEC 6004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-2, IEC 60601-2-37 and ISO 10993-1.

Conclusion:

The conclusions drawn from testing of the DC-3/DC-3T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of what appears to be an abstract symbol, possibly representing a person or a bird.

JUL = 9 2009

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: K091941

Trade/Device Name: DC-3/DC-3T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: June 24, 2009 Received: June 30, 2009

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-3/DC-3T Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C5A ୧୯.୮୮.୧ 7L4A 716 10L4 6C2 6LE7

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

6LB7
3C1
2P2
7L5
7LT4
D6-2

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 Paul Hardy at (240) 276-3666.

Sincerely yours,

Heidi Remer
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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× |

Diagnostic Ultrasound Indications for Use Form

Transducer

DC-3/DC-3T

System Model:

510(k) Number(s)

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	Note 1, 2, 3, 4
Abdominal	P	P	P	P	P	P	P	Note 1, 2, 3, 4
Intraoperative (specify)*	P	P	P	P	P	P	P	Note 2, 3, 4
Intraoperative (Neuro)
Laparoscopic
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 1, 2, 3, 4
Adult Cephalic	P	P	P	P	P	P	P	Note 1,2, 3
Trans-rectal	P	P	P	P	P	P	P	Note 2, 3, 4
Trans-vaginal	P	P	P	P	P	P	P	Note 2, 3
Trans-urethral								Note 2, 3
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 2, 3, 4
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 2, 3, 4
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	Note 1,2, 3
Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2, 3
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	P	P	P		P	P	P	Note 2, 3, 4
	P	P	P		P	P	P	Note1, 2, 3, 4

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

0085

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

Mindray Co. Ltd.- DC-3/DC-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

3CSA

Transducer

System Model: 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	Note 1, 2, 3
Abdominal	P	P	P		P	P	P	Note 1, 2, 3
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1, 2, 3
Small organ(specify) **								Note 1, 2, 3
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1, 2, 3
Other (specify) ***	P	P	P		P	P	P	Note 1, 2, 3
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.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
System	Diagnostic Ultrasound Indications for Use Form
Model:			6CVI	Transducer	X
510(k) Number(s)

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	Note 2, 3
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	P	P	Note 2, 3
Trans-vaginal	P	P	P		P	P	P	Note 2, 3
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify) ***	P	P	P		P	P	P	Note 2, 3
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.
*Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D

Note 3: iScape
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P
Intraoperative (specify)*					P	P	P	Note 2, 3, 4
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P
Small organ(specify)**	P	P	P		P	P	P	Note 2, 3, 4
Neonatal Cephalic	P	P	P		P	P	P	Note 2, 3, 4
Adult Cephalic						P	P	Note 2, 3, 4
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 2, 3, 4
Intravascular					P	P	P	Note 2, 3, 4
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P
Other (specify)***					P	P	P	Note 2, 3, 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.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: iBeam

Note 2: Smart3D Note 3: iScape

Note 4: iBeam

Hula leum

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

0086

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

Diagnostic Ultrasound Indications for Use Form

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

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

Diagnostic Ultrasound Indications for Use Form System Transducer Model: 7L4A 510(k) Number(s) ·

Hechd Lewn

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

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

System Transducer × Model: 716 510(k) Number(s) Mode of Operation Clinical Application Color Amplitude B M Combined PWD CWD Other (specify) Doppler Doppler (specify) Ophthalmic Fetal Abdominal P P P P P P Intraoperative (specify)* Note 2, 3, 4 Intraoperative (Neuro) Laparoscopic Pediatric P P P P P Small organ(specify)** P Note 2, 3, 4 P P P P P P Neonatal Cephalic Note 2, 3, 4 P P P P p Adult Cephalic P Note 2, 3, 4 Trans-rectal Trans-vaginal Trans-urethral Trans-esoph.(non-Card.) Musculo-skeletal Conventional P P P P P Musculo-skeletal Superficial P Note 2, 3, 4 P P P P P Intravascular P Note 2, 3, 4 Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-Cardiac Peripheral Vascular P P P P P P Other (specify) ** * Note 2, 3, 4 N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B, * Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc. ***Other use includes Urology. Note I: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3: iScape Note 4: iBeam

Hes Rem

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

Diagnostic Ultrasound Indications for Use Form

0089

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

Diagnostic Ultrasound Indications for Use Form System Transducer × Model: I OLA 510(k) Number(s) Mode of Operation Clinical Application Color-Amplitude B Combined M PWD CWD Other (specify) Doppler Ophthalmic Doppler (specify) Fetal Abdominal p P P P Intraoperative (specify)* P P Note 2, 3, 4 Intraoperative (Neuro) Laparoscopic Pediatric P P P P P Small organ(specify) ** P Note 2, 3, 4 P P P P P Neonatal Cephalic P Note 2, 3, 4 P P P P Adult Cephalic P P Note 2, 3, 4 Trans-rectal Trans-vaginal Trans-urethral Trans-esoph.(non-Card.) Musculo-skeletal Conventional P P P P Musculo-skeletal Superficial P P P Note 2, 3, 4 P p P Intravascular P P Note 2, 3, 4 Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph (Cardiac) Intra-Cardiac Peripheral Vascular p P P P P Other (specify) ** P Note 2, 3, 4 N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, PW +Color+ B, Power + PW +B, *Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc. ***Other use includes Urology. Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D

Helda Perm

ision Sign Off) on of Reproductive, Abdominal a Radiological Devices 510(k) Number

Note 3: iScape Note 4: iBeam

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

and the comments of the count

...

、

System
Model:	6C2
510(k) Number(s)

Diagnostic Ultrasound Indications for Use Form

Transducer	X
------------	---

Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 2, 3
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 2, 3
Small organ(specify)**
Neonatal Cephalic	P	P	P		P	P	P	Note 2, 3
Adult Cephalic	P	P	P		P	P	P	Note 2, 3
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	P	P	P		P	P	P	Note 2, 3
Cardiac Pediatric	P	P	P		P	P	P	Note 2, 3
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	P	P	P		P	P	P	Note 2, 3.

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.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note 4: iBeam

(Division Sign-Off)

Division of Reproductive, Abdominal and

Radiological Devices

510(k) Number	K091941
---------------	---------

0091

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

System				Transducer		X
Model:		6LE7
510(k) Number(s)

Clinical Application						Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	Note 2, 3, 4
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P
Trans-vaginal	P	P	P		P	P	P	Note 2, 3, 4
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	P	P	P	P	P	P	P	Note2, 3, 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.* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: iBeam

Diagnostic Ultrasound Indications for Use Form

Hele Keen

(Division Sign off)

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

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

. *-

: : : : : : : : : : : : : : : : : : : : : : : : :

System

Transducer X

Model:	6LB7
510(k) Number(s)

Clinical Application	B	M	PW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	P	Note 2, 3, 4
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	P	P	P	P	P	P	Note2, 3, 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.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note 4: iBeam

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices

510(k) Number	K091941
---------------	---------

Diagnostic Ultrasound Indications for Use Fe

0093

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

System Transducer × Model: 3C1 510(k) Number(s) Mode of Operation Clinical Application PW Color Amplitude Combined B M CWD Other (specify) D Doppler Doppler (specify) Ophthalmic Fetal P P P p P P Note 1, 2, 3 Abdominal P P P P P P Note 1, 2, 3 Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic Pediatric P P P P p P Note 1, 2, 3 Small organ(specify)** Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal Conventional Musculo-skeletal Superficial Intravascular Cardiac Adult P P P P P P Note 1, 2, 3 Cardiac Pediatric P P P P p P Note 1, 2, 3 Intravascular (Cardiac) Trans-esoph.(Cardiac) Intra-Cardiac Peripheral Vascular Other (specify)*** N=new indication; P=previously cleared by FDA; E=added under Appendix B Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B, * Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc. ***Other use includes Urology. Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3: iScape Note 4: iBeam (Division Sign-Offy Division of Reproductive, Abdon

0094

Radiological Devices 510(k) Number

Diagnostic Ultrasound Indications for Use Form

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

Mindray Co. Ltd. - DC-3/DC

:40 : 0 : 0 : 0 : 0 : 0 :

System				Transducer		X
Model:			2P2
510(k) Number(s)

Clinical Application						Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	Note 1,
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	Note 1,
Small organ(specify)**
Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,
Adult Cephalic	P	P	P	P	P	P	P	Note 1,
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2
Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
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.*Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: iBeam

Diagnostic III+

: . .

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

Mindray Co. Ltd.- DC-3/DC-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

System
Model:	7L5
510(k) Number(s)
Transducer	X

	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Clinical Application
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	Note 2, 3, 4
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	Note 2, 3, 4
Small organ(specify)**	P	P	P	P	P	P	Note 2, 3, 4
Neonatal Cephalic	P	P	P	P	P	P	Note 2, 3, 4
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P	P	P	P	P	Note 2, 3, 4
Musculo-skeletal Superficial	P	P	P	P	P	P	Note 2, 3, 4
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	P	P	P	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.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Nofe 4: iBeam

Note 4: iBeam

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Kem

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

.
.

0096

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

Mindray Co. Ltd.- DC-3/DC-3T Diagnostic Ultrasound System

7LT4

Diagnostic Ultrasound Indications for Use Form

System Model: 51006 N

Transducer

—

		Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 2, 3, 4
Intraoperative (specify)*	P	P	P		P	P	P	Note 2, 3, 4
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 2, 3, 4
Small organ(specify)**	P	P	P		P	P	P	Note 2, 3, 4
Neonatal Cephalic	P	P	P		P	P	P	Note 2, 3, 4
Adult Cephalic						P	P	Note 2, 3, 4
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletalConventional	P	P	P		P	P	P	Note 2, 3, 4
Musculo-skeletalSuperficial	P	P	P		P	P	P	Note 2, 3, 4
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 2, 3, 4
Other (specify) ***
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal	N	N	N		N	N	N	Note 1, 2
Abdominal	N	N	N		N	N	N	Note 1, 2
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	Note 1, 2
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
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.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: iBeam
Note 5: 4D
(Division Sign-Off)
Division of Reproductive, Abdominal andRadiological Devices

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

*** Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D Note 3: iScape

Note 4: (Beam

Note 4. Beam

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

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

Diagnostic Ultrasound Indications for Use Form

Transducer

× ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

System Model: 510(k) Number(s)

D6-2

098

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.