Predicate Devices

K063500, K010631, K012080, K042540, K990339, K062247, K061129

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and features (B-Mode, M-Mode, Color mode, PW mode, CW mode, Power/DirPower mode, Smart3D, iScape, Free Xros M) without mentioning any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No.
The device is a diagnostic ultrasound system intended to acquire and display ultrasound images for evaluation, not for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "ultrasound evaluation," and the "Device Description" calls it an "ultrasound diagnostic system," indicating its purpose is to aid in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "general purpose, mobile, software controlled, ultrasound diagnostic system" and mentions employing "an array of probes," which are hardware components essential for acquiring ultrasound images.

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 various anatomical sites. This involves using ultrasound technology to visualize internal structures of the body.
Device Description: The description details a "Diagnostic Ultrasound System" that acquires and displays ultrasound images.
Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not mention analyzing any such specimens.

The device is a diagnostic imaging system that uses ultrasound waves to create images of the body, which is a different category of medical device than 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, pediatric, neonatal cephalic, musculoskeletal (general and superficial), Urology/Prostate and intraoperative (liver, gallbladder, pancreas).

Product codes

IYO, IYN, ITX

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).

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, pediatric, neonatal cephalic, musculoskeletal (general and superficial), Urology/Prostate and intraoperative (liver, gallbladder, pancreas).

Indicated Patient Age Range

Not Found

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)

Not Found

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

Not Found

Predicate Device(s)

K063500, K010631, K012080, K042540, K990339, K062247, K061129

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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:

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).

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, pediatric, neonatal cephalic, musculoskeletal (general and superficial), Urology/Prostate and intraoperative (liver, gallbladder, pancreas).

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 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	PW
D	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	PW
D	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	PW
D	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	PW
D	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	PW
D	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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 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.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	PW
D	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	PW
D	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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