(24 days)
Not Found
No
The summary describes a standard software-controlled ultrasound system with various imaging modes and post-processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The performance studies and device description focus on traditional ultrasound technology and safety standards.
No
The device is described as a "Diagnostic Ultrasound System" and its function is to "acquire and display ultrasound data," indicating its use for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System..." and details its use in various exams to generate diagnostic information. The "Device Description" also refers to it as an "ultrasonic diagnostic system."
No
The device description explicitly states it is a "software controlled, ultrasonic diagnostic system" and mentions the use of "an array of probes" and the transmission of "ultrasonic energy into patients," indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the DC-60/DC-60S/DC-60 Exp/DC-55 is a Diagnostic Ultrasound System. It works by transmitting ultrasonic energy into the patient's body and processing the received echoes to generate images of internal structures and fluid flow.
- No Sample Analysis: There is no mention of this device analyzing samples taken from the body. Its function is based on imaging within the body.
Therefore, based on the provided information, this device falls under the category of in vivo diagnostic imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
DC-60/DC-60 Exp/DC-55 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 exam.
Product codes
IYN, IYO, ITX, LLZ
Device Description
DC-60/DC-60S/DC-60 EXP/DC-55 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).
This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.
The differences between these 4 models are shown as followed table:
| Product Model | B-Profile | B-Histogram |
|---|---|---|
| DC-60 | √ | √ |
| DC-60 Exp | √ | X |
| DC-60S | X | X |
| DC-55 | X | √ |
Note: B histogram and B-Profile are the only two differences between the three models. They have exactly the same hardware and software configuration, mechanical features and appearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 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: K152545
Trade/Device Name: DC-60/DC-60S/DC-60 Exp/DC-55 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: September 4, 2015 Received: September 8, 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 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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
Indications for Use (Describe)
DC-60/DC-60 Exp/DC-55 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 exam.
✔ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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 PRAStaff(@fda.hhs.gov
"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."
3
Diagnostic Ultrasound Indications For Use Format
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: N/A
| Intended Use. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||
|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | 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 | Note 1,2,4,7 | ||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1,2,4,7 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6,7 | |
| Fetal Imaging & Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6,7 |
| Trans-rectal | N | N | N | N | N | N | Note 1, 2,4,6,7 | ||
| Trans-vaginal | N | N | N | N | N | N | Note 1, 2,4,6,7 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1,2,4,7 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | Note 1, 2,4,7 | ||
| Intravascular | |||||||||
| 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 | |
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2,4,6,7 |
| 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 | |||||||||
| **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 In Vitro Diagnostics and Radiological Health (OIR) |
4
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System:
Transducer: 3C5A
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|---|
| --------------- | ------------------------------------------------------------------------------------ |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K120699); 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. | |||||||||
| ***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) |
5
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: 6C2
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K120699); 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. | ||||||||||
| ***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) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track 1) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4,7 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1, 2, 4,7 | |||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | P | Note 1, 2, 4,7 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | P | Note 1, 2, 4,7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K120699); 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. | ||||||||||
| ***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) |
6
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System:
Transducer: 7L4A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
7
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System:
Transducer: L14-6NE
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows. | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | --------------------------------------------------------------------------------------------------- |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,7 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,7 | |||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | P | Note 1,2, 4,7 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | P | Note 1,2, 4,7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,2, 4,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150204); 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. | ||||||||||
| ***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) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150204); 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. | ||||||||||
| ***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) |
8
System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
Transducer: V11-3
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
9
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: V11-3B
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
|---|---|
| -------------------------------------------------------------------------------------------------- | -- |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| (Track 1 | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | Adult Cephalic | ||||||||
| & Other | Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| vessel | Other (Specify***) | ||||||||
| N=new indication; P=previously cleared by FDA(K150204); | 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. | |||||||||
| ***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) |
10
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: P4-2
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|
| Clinical Application | Mode of Operation | Other (specify) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 |
| 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, 2,4,5,6,7 | |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K120699); 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. | |||||||||
| ***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) |
11
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: P7-3
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,6 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,6 | ||
| Fetal Imaging | Adult Cephalic | |||||||||
| & Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6 | ||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K120699); 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. | ||||||||||
| ***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) |
12
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System: Transducer: D7-2E
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
|---|---|
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 3, 4, 6 | |||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 3, 4, 6 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150204); 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. | ||||||||||
| ***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) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | ||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150204); 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. | ||||||||||
| ***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) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | |||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K120699); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +1 | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **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) |
13
System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
Transducer: CW5s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
14
System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
Transducer: CW2s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
15
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: ___________________
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 8188 5640 Fax: +86 755 2658 2680
Contact Person:
Yang Zhaohui 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: July 27, 2015
2. Device Name: DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound System Classification
Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX) 21 CFR 892.2050 Picture Archiving and Communications System(LLZ)
3. Device Description:
16
DC-60/DC-60S/DC-60 EXP/DC-55 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).
This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.
| Product Model | B-Profile | B-Histogram |
|---|---|---|
| DC-60 | √ | √ |
| DC-60 Exp | √ | X |
| DC-60S | X | X |
| DC-55 | X | √ |
The differences between these 4 models are shown as followed table:
Note: B histogram and B-Profile are the only two differences between the three models. They have exactly the same hardware and software configuration, mechanical features and appearance.
4. Intended Use:
DC-60/DC-60S/DC-60 EXP/DC-55 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 exam.
5. Comparison with Predicate Devices:
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate
Device | Manufacturer | Model | 510(k) Control
Number |
|---------------------|--------------|-------|--------------------------|
| 1 | Mindray | DC-70 | K150204 |
| 2 | Mindray | DC-T6 | K120699 |
| 3 | Mindray | DC-8 | K150080 |
17
DC-60/DC-60S/DC-60 EXP/DC-55 has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
- Subject device DC-60/DC-60S/DC-60 EXP/DC-55 has the same intended uses as the . predicated device DC-70(K150204)
| Subject Device | Predicate device |
|---|---|
| DC-60/DC-60S/DC-60 EXP/DC-55 | DC-70(K1502041) |
| The DC-60/DC-60S/DC-60 EXP/DC-55 | |
| 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. | The DC-70 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. |
- All of the patient contact material of the DC-60/DC-60S/DC-60 EXP/DC-55 are the ● same as that of the predicated device DC-8(K150080).
- The acoustic power levels of DC-60/DC-60S/DC-60 EXP/DC-55 are below the limits of FDA, which is the same as the predicated device DC-70(K1502041).
- DC-60/DC-60S/DC-60 EXP/DC-55 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device DC-70(K150204).
- . DC-60/DC-60S/DC-60 EXP/DC-55 has the same imaging modes as the predicated device DC-70(K150204): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode and combined mode.
18
- . DC-60/DC-60S/DC-60 EXP/DC-55 has some special functions. All of them are identical as the predicated device DC-70(K150204).
- DC-60/DC-60S/DC-60 EXP/DC-55 has the same capacity in term of making . comments and body marks on the images, reporting patient exam results as the predicated device DC-70(K150204).
| Subject device
| DC-60/DC-60S/DC-60 EXP/DC-55 | Predicated device |
|---|---|
| 3C5A | 3C5A (K120699) |
| 6C2 | 6C2 (K120699) |
| 7L4A | 7L4A (K120699) |
| P4-2 | P4-2 (K120699) |
| P7-3 | P7-3 (K120699) |
| V11-3 | V11-3E (K150204) |
| V11-3B | V11-3BE (K150204) |
| L14-6NE | L14-6NE (K150204) |
| D7-2E | D6-2E (K150204) |
| CW2s | CW2s (K150080) |
| CW5s | CW5s (K150204) |
- . DC-60/DC-60S/DC-60 EXP/DC-55 has similar probes as the predicated device:
- . DC-60/DC-60S/DC-60 EXP/DC-55 has the same measurement and calculation functions as the predicated device DC-70(K150204).
6. Non-clinical Tests:
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:
- UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- AAMI / ANSI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
19
- . IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
- . IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- . ISO14971 Medical devices - Application of risk management to medical devices
- ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and ■ testing within a risk management process
- . IEC 62366 Medical devices - Application of usability engineering to medical devices
- IEC 62304 Medical device software - Software life cycle processes These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.
7. Clinical Studies
Not applicable. The subject of this submission, DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Conclusion:
Intended uses and other key features are consistent with traditional clinical practices. FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.