DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems

K150204 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Apr 10, 2015 · Radiology

Device Facts

• Record ID: K150204
• Device Name: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.

Device Story

The DC-70 series is a software-controlled diagnostic ultrasound system. It uses an array of probes (linear and convex, 3.0-10.0 MHz) to transmit ultrasonic energy into the body and receive echoes. The system processes these signals to generate real-time 2D, M-mode, Doppler (PW, CW, Color, Power/Dirpower), and Tissue Harmonic Imaging (THI) displays. It is operated by clinicians in clinical settings to visualize anatomic structures and analyze fluid flow. The system supports specialized measurements, calculations, body marks, and annotations. Output is displayed on-screen for the clinician to assess patient anatomy and pathology, aiding in diagnostic decision-making. The device is intended for a wide range of patient populations, including neonates and pregnant women.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements (UD 2), electrical/mechanical safety (ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and software lifecycle processes (IEC 62304).

Technological Characteristics

Software-controlled diagnostic ultrasound system. Probes: linear and convex arrays (3.0-10.0 MHz). Imaging modes: B, M, PW, CW, Color, Power/Dirpower, THI, and combined modes. Connectivity: supports reporting and image annotation. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, IEC 62304.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, and urology exams.

Regulatory Classification

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.

Predicate Devices

• Mindray DC-8 (K132341)
• Mindray DC-N2 (K132779)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 10, 2015

Shenzhen Mindray Bio-Medical Electronics Co., LTD % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K150204 Trade/Device Name: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, LLZ Dated: March 15, 2015 Received: March 19, 2015

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

| 510(k) Number (if known) | K150204 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System |
| Indications for Use (Describe) | The DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams. |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:white;stroke:black;stroke-width:1;" width="12"></rect> <path d="M2,2 L10,10 M2,10 L10,2" stroke="black" stroke-width="1"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:white;stroke:black;stroke-width:1;" width="12"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

13 - 015 € L = 800 - 1 > 34

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

| C<br>) |
|--------|
| C<br>p |
| 8 |
| 1 |
| p<br>D |

| | | | | | | | Mode of Operation | | | |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-------------------|--|
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | | | | | | | | | | |
| General | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | N | N | N | N | N | N | N | Note 1,2,3, 4,6,7 | |
| | Abdominal | N | N | N | N | N | N | N | Note 1,2,3, 4,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| Fetal Imaging<br>& Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| | Trans-rectal | N | N | N | N | N | N | N | Note 1,2,3,4,6,7 | |
| | Trans-vaginal | N | N | N | N | N | N | N | Note 1,2,3,4,6,7 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | Note 1,2,4,7 | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| | Other (Specify***) | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| 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 + | | | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3:4D(Real-time 3D) | | | | | | | | | | |
| Note 4: iScape | | | | | | | | | | |
| Note5: TDI | | | | | | | | | | |
| Note6: Color M | | | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | | | |
| Note8: Elastography | | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | | |

# ายทาง 1 จรุป 104 รู้ที่ 104 รินด้ายว่า 2017 คน

:ພາອາຣຽ

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

| C<br>p |
|--------|
| C<br>p |
| 8 |
| I |
| 3 |

| ISSUSURICIE | コフ-Cつ | | | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------|-----------------|
| | sevollo1 se vbod namud att 10 sizylems woft biult 10 gaigsmi bauosertlu 201501111 | | | | | | | | | |
| | സ്ഥാപിന്റെ Analistical | | | | | | uoitsaaqO to apoM | | | |
| ານສະຫຼຸບ<br>(xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx | Specific (Track Krack I & | B | M | awa | വഹ | appado T<br>Color | əpmişdir. Azərbaycan filmləri Filmin Mənbə Film Sənədlər Rəmaniya Rəsmin Film Sənədlər Rəsmin Film Sənədlər Film Sənədli Film Sənədlər Film Sənəd<br>Doppler | Combined<br>(({\iseds) | (yüzədə) vəqic | |
| phphphalmic | ophthalmic | | | | | | | | | |
| | Atata | P | P | P | | P | P | P | ote 1,224,6<br>.7 | |
| | bbbonds | P | P | P | | P | P | P | ote 1, 2, 4,6, | |
| | (*vfiisads) aviisiado-sun | | | | | | | | | |
| | intra-operative (Neuro | | | | | | | | | |
| | ാമ്പാട്ടാവുമുള | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | lote 1, 2, 4,6<br>7 | |
| | ***1109ds) urg.10 lleurs | | | | | | | | | |
| | sing the Charic | | | | | | | | | |
| ສິນເຮືອນໄປໄປໄປໄປໄປປຸງໆ | Adult Cephalic | | | | | | | | | |
| & Other | Trans-rectal | | | | | | | | | |
| | lanigav-suer | | | | | | | | | |
| | rans-urethu | | | | | | | | | |
| | aren-non) .uqose-sus r | | | | | | | | | |
| | Conventional<br>assembo-skeleta | P | P | P | | P | P | P | lote 1, 2, 4,6,<br>7 | |
| | ะเอ็อฟุร-oไทวรที่/ | | | | | | | | | |
| | laisifinding | | | | | | | | | |
| | arinoseveru | | | | | | | | | |
| | lubA osibus | | | | | | | | | |
| | ardiac Pediatric | | | | | | | | | |
| Cardia | intravascular (Cardiac | | | | | | | | | |
| | rans-esoph. (Cardiac | | | | | | | | | |
| | ാല്പ്മാലവന | | | | | | | | | |
| Periphers | Participing and the sex of | P | P | P | | P | P | P | lote 1, 2, 4,6,<br>7 | |
| vesssel | (***(Iiつきq() 19410 | | | | | | | | | |
| | :(14ESEIx)ACH vd bernsis vlauoiverq=9 : noitroibui wau=M | | | | | | ə xibnəqqə qəbun bəbbə=Ə | | | |
| | 1 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 -<br>on the say bas . Sistemore, the mores, and vessessed in | | | | | | | | | |
| | 2012-11-15 11:51 pm stressts theysels. testes | | | | | | | | | |
| | .vgolorU sebulɔni əsu 19db0* | | | | | | | | | |
| | ຂ້າມອອກ ການປະກວດຄວາມ ເດດ ຂອງ ອາເປນລາວ ອາໄປ .ງິດເມືອງຂອງປີ ວັນທຸລາວປີ : I ອາປ | | | | | | | | | |
| | Note 2: SamartISD | | | | | | | | | |
| | ote 3:4D(Real-time SD | | | | | | | | | |
| | Note 4: İSCape | | | | | | | | | |
| | ldır. İstinadlar Alban Alan Alan Alan Alan Alan Alan Alan Alan Alaban Alabaycan Alan Alan Alan Alan Alan Alat Alat Alat Alat Alat Alat Alat Alat Al | | | | | | | | | |
| | M 1010ଠ :9510k | | | | | | | | | |
|…