Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" and its function is to "acquire and display ultrasound images". There is no mention of treating or preventing diseases.

Diagnostic

Yes
The device description clearly states, "The DC-3/DC-3T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system." Additionally, the "Intended Use / Indications for Use" section describes its use for "ultrasound evaluation," which is a diagnostic activity.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "software controlled, ultrasound diagnostic system" and mentions employing "an array of probes" and conforming to hardware safety standards (IEC 60601-1, etc.), indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for "ultrasound evaluation of abdominal, cardiac, small parts...". This describes a diagnostic imaging procedure performed on a living patient, not a test performed on a sample taken from the body (which is the hallmark of an IVD).
Device Description: The description details an "ultrasound diagnostic system" that acquires and displays ultrasound images. This aligns with in-vivo imaging, not in-vitro testing.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD devices.

Therefore, the DC-3/DC-3T Diagnostic Ultrasound System is a diagnostic imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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, intraoperative (abdominal, thoracic, and vascular etc. ), pediatric, neonatal cephalic, musculoskeletal (general and superficial).

Product codes

IYN, IYO, ITX

Device Description

The DC-3/DC-3T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, intraoperative (abdominal, thoracic, and vascular etc. ), pediatric, neonatal cephalic, musculoskeletal (general and superficial).

Indicated Patient Age Range

pediatric, neonatal cephalic

Intended User / Care Setting

qualified physician

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)

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 Output Display Standard: 2004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 and ISO 10993-1.

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

Not Found

Predicate Device(s)

K081320, K083001, K072164

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

DEC 1 2 2008

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 §807.92(c).

The assigned 510(k) number is: צורך 3 לס ל

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:

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: October 24, 2008

2. 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-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 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 K081320, and the other predicate devices are listed below: Mindray M5 (K083001), Mindray DC-6 (K072164).

0042

1

4. Device Description:

The DC-3/DC-3T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power 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.

5. Intended Use:

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, intraoperative (abdominal, thoracic, and vascular etc. ), pediatric, neonatal cephalic, musculoskeletal (general and superficial).

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 Output Display Standard: 2004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, 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.

0043

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President CITECH, Medical Device Testing and Consulting 5200 Butler Pike Plymouth Meeting, PA 19462-1298

DEC 1 2 2008

Re: K083505

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: TYN, IYO, and ITX Dated: November 25, 2008 Received: November 26, 2008

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

6CV1	10L4	3C1
3C5A	6C2	2P2
7L4A	6LE7	7L5
7L6	6LB7	7LT4

3

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/cdrb/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.

Sincerely yours,

Joyce M. Whang, Ph.D.
Acting Director, Division of Re

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

Enclosure(s)

4

×

Diagnostic Ultrasound Indications for Use Form

Model:

System

Transducer DC-3/DC-3T 083505

510(k) Number(s)

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

(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)

Hubert Lee

5

System				Transducer		X
Model:			6CV1
510(k) Number(s)			K083505

	Mode of Operation
Clinical Application	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
Note 4: iBeam

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

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083505

6

Transducer

×

System Model:

510(k) Number(s)

3C5A
K083505

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic
Petal	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
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	N	N	N		N	N	N	Note 1, 2, 3
Other (specify)***	N	N	N		N	N	N	Note 1, 2, 3

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.

Nete 2: Smart3D

Note 3: iScape Note 4: iBeam

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

Concurrence of CDRH, Office of Device Evaluation(DDE)

Prescription USE (Per 21 CFR 801.109)

Skelut Keun

7

System Model: Transducer ×

510(k) Number(s)

083505

7L4A

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N		N	N	N	Note 2, 3, 4
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	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
Note 4: iBeam

(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)

Herbert Lewis

8

System
Model:	7L6
510(k) Number(s)	K083505

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N		N	N	N	Note 2, 3, 4
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	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) ***								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

(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)

Helen Burns

9

Diagnostic Ultrasound Indications for Use Form10L4