Predicate Devices

['K#010631', 'K#051500', 'K#012080', 'K#042540', 'K#052894', 'K#052410', 'K061189']

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound modes and hardware.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" for "ultrasound evaluation" and "acquire and display ultrasound images," which points to diagnostic rather than therapeutic use.

Diagnostic

Yes
The "Device Description" explicitly states, "The DC-6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system."

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," 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 imaging the internal structures of the body using ultrasound waves.
Device Description: The description confirms it's a "Diagnostic Ultrasound System" that acquires and displays ultrasound images.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body. IVD devices are specifically designed for in vitro examination of specimens derived from the human body.

The device described is a diagnostic imaging device, specifically an ultrasound system, used for non-invasive examination of the body.

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 adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.

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

IYN, IYO, 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, 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 and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.

Indicated Patient Age Range

Adult, pediatric, fetal

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 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.

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

Not Found

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

K#010631, K#051500, K#012080, K#042540, K#052894, K#052410, K061189

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

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 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

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

October 16, 2006 Date Prepared:

Device Name: DC-6 Diagnostic Ultrasound System

Classification

Regulatory Class: Il

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-FYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Marketed Device:

DC-6 Diagnostic Ultrasound System is substantially equivalent to the following devices: Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500), Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-9900 (#K061189).

0042

1

$$
\mathbb{Q}\mathbb{Q}\mathbb{S}\mathbb{Q}
$$

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, 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 and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.

5. Intended Use:

The device is intended for use by a qualified physician for ultrasound evaluation of adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.

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

0043

2

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, all facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2006

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

Re: K063500

Trade Name: DC-6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 17, 2006 Received: November 20, 2006

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of December 6, 2006.

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.

3

Page 2 - Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

3C1

This determination of substantial equivalence applies to the following transducers intended for I mis determination of backs of our as described in your premarket notification:

Transducer Model Number

6CV1

7L4

૩૮૨

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 it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA oun or louits in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advisou mail i Driv issum that your device complies with other requirements of the Act that I Dri has made a dollations 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 CITY art 607), adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 This letter will anow you to orgin manunting of your device to a legally marketed nonication. The I Driving of casting 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 IT you desire specific at 12-12-12-12-120. Also, please note the regulation entitled, Contact the Office of Confightalso as (2 + notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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

4

Page 3 - Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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

Sincerely yours,

David h. hyman

f

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

Enclosure(s)

5

3500

× System

Transducer

Model:

DC-6

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N
Abdominal		N	N	N		N	N	N	N
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N	N	N
Small organ(specify)		N	N	N		N	N	N
Neonatal Cephalic		N	N	N		N	N	N
Adult Cephalic
Cardiac		N	N	N		N	N	N	N
Transesophageal
Transrectal		N	N	N		N	N	N
Transvaginal		N	N	N		N	N	N
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N	N
Laparoscopic
Musculo-skeletal
Conventional		N	N	N		N	N	N
Musculo-skeletal Superficial		N	N	N		N	N	N
Other (specify)
N=new indication; P=previously cleared by FDA; E=added under Appendix E

A dditional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B,

Power + PW +B.

*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.

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

(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)

(Division Sign-Off)

0047

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

6

System	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Model:		3CS

× Transducer

510(k) Number(s)

4

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N
Abdominal		N	N	N		N	N	N	N
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B,

Power + PW +B.

*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.

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

510(k) Number _

Concurrence of CDRH, Office of Device Evaluation(ODE)

David h. Slayton
(Division Sign-Off)

Division of Reproductive, Abdominal, Prescription USE (Per 21 CFR 801.109) and Radiological Devices

7

System

Transducer ×

3CI Model:

510(k) Number(s)

D6 5500

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N	N	N
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N	N	N
Small organ(specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
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.

*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

David le. Leggans. 0043

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

Prescription USE (Per 21 CFR 801.109)

8

System
Transducer	X
Model:	6CV1
510(k) Number(s)	K063500

	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)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N.	N	N
Transvaginal		N	N	N		N	N	N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

Additional comments: Combined modes: B+M, PW+B, Color +B, Power + B, PW +Color+ B,

Power + PW +B.

(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)

(Division Sign-Off) 4
Division of Reproductive, Abdominal,.
and Radiological Devices
510(k) Number K063500

0050

9

System Model:

Transducer

7L4

510(k) Number(s)

K068500

×

	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) **		N	N	N		N	N	N
Neonatal Cephalic		N	N	N		N	N	N
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N	N
Laparoscopic
Musculo-skeletal
Conventional		N	N	N		N	N	N
Musculo-skeletal Superficial		N	N	N		N	N	N
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.

(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)

0051

(Division Sign-Off)
Division of Reproductive, Abdominal,..
and Radiological Devices
510(k) Number K063500