(113 days)
Not Found
No
The document describes a standard ultrasonic diagnostic system and does not mention any AI or ML capabilities in the device description, intended use, or performance studies.
No
The device is described as an "ultrasonic diagnostic system" intended for various "exams," indicating its use for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "Diagnostic Ultrasound System" and is "intended for use in fetal, abdominal... and urology exams," all of which are diagnostic applications. Additionally, the "Device Description" calls it an "ultrasonic diagnostic system."
No
The device description explicitly states it is an "ultrasonic diagnostic system" that employs "an array of probes," which are hardware components necessary for acquiring ultrasound data. While it is software-controlled, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a diagnostic ultrasound system used for imaging various anatomical sites in different patient populations. This is a form of in vivo (within the living body) diagnostic imaging.
- Device Description: The description details the system's function in acquiring and displaying ultrasound data using different modes. This is consistent with an ultrasound imaging device, not a device that analyzes samples taken from the body.
- 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, which are the hallmarks of an IVD.
Therefore, the DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S 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-esoph(Cardiac), musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, LLZ
Device Description
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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, iScape,4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging 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.
Mentions image processing
Yes
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, Trans-esophageal (Cardiac), musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, 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)
Non-clinical tests were performed evaluating acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. The device conforms to applicable medical safety standards. Clinical studies were not required. The conclusion is that the device is substantially equivalent to currently cleared devices in terms of safety and effectiveness.
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.
K150204, K150080, K162267, K152545, K160807
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
§ 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 a stylized image of an eagle with three heads, depicted in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. April 20, 2017 YANG ZHAOHUI ENGINEER OF TECHNICAL REGULATION MINDRAY BUILDING, KEJI 12TH ROAD SOUTH HI-TECH INDUSTRIAL PARK NASHAN, SHENZHEN 518057 CN
Re: K163690
Trade/Device Name: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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 30, 2017 Received: April 4, 2017
Dear Mr. Yang:
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 (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 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
510(k) Number (if known)
Device Name
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Indications for Use (Describe)
The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-78/ DC-70S 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-esoph(Cardiac), musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Diagnostic Ultrasound Indications For Use Format
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer:
шиниси N/A
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: ﺴﻤﻴﻨﻴ
| 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, 4,6,7 | ||
| Abdominal | P | P | P | P | P | P | P | Note 1,2,3, 4,6,7,9 | |
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,7,8 | ||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,4,6,7 |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,6,7 | |
| Trans-rectal | P | P | P | P | P | P | Note 1,2,3,4,6,7 | ||
| Trans-vaginal | P | P | P | P | P | P | Note 1,2,3,4,6,7,8 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1,2,4,6,7,8 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2,4,7,8 | ||
| 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) | N | N | N | N | N | N | N | Note 1, 5,6 | |
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2,4,6,7,8 | |
| Other (Specify***) | P | P | P | P | P | P | 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 +B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography | |||||||||
| Note 9: Contrast imaging | |||||||||
| (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
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | C5-2E |
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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, 4,6,7,9 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Small Organ (Specify**) | |||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| 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***) |
1 Parisation
Hitchuru
Hearthern Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
5
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | C11-3E |
| 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 | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Small Organ (Specify**) | ||||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| 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(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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| 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 | ||||||||||
| Imaging & | ||||||||||
| Other | 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 | |||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Cardiac | Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3: 4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| 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, 4,7,8 | |||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Neonatal Cephalic | |||||||||
| 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***) | ||||||||||
| 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 | ||||||||||
| Imaging & | ||||||||||
| Other | 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, 4,7,8 | |||
| Neonatal Cephalic | ||||||||||
| 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 | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| 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(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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
I Tanback
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
6
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: C C7-3E
Intenueu
Home Diagno
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
7
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L12-3E
Intendeu
Hagnos
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
8
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
9
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | L14-6WE |
| 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 | ||||||||||
| Imaging & | ||||||||||
| Other | 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, 4,7,8 | |||
| Neonatal Cephalic | ||||||||||
| 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(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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| 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 | ||||||||||
| Imaging & | ||||||||||
| Other | 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 | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Trans-vaginal | P | P | P | P | P | N | Note 1, 2, 4,6,7,8 | |||
| 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***) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| 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 | ||||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | ||||||||||
| 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, 4,6,7,8 | |||
| 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***) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
miendeu Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: ﺴﺘﻠ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
10
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V11-3E
Intendeu
Haansducer: Diagnost
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
11
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V11-3BE
Intenueu
Haardeu Diagnostic
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
12
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | V11-3WE |
| 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 | ||||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | ||||||||||
| 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 Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| 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 | P | P | P | P | P | P | Note 1, 2,4,6,7 | |||
| Small Organ (Specify**) | ||||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| 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(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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
i Pansado
III entileu Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
13
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
14
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | P7-3E |
| 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 1,2,4,6 | |||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2,4,6 | ||||
| Fetal | |||||||||||
| Imaging & | |||||||||||
| Other | Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,4,6 | |||
| Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,6 | |||
| 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 | |||
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6 | |||
| 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. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note5: TDI | |||||||||||
| Note6: Color M | |||||||||||
| Note7: Biopsy Guidance | |||||||||||
| Note8: Elastography | |||||||||||
| Note 9: Contrast imaging | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General | Ophthalmic | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Imaging & | |||||||||||
| Other | Fetal | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | |||
| Abdominal | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal (Conventional) | |||||||||||
| Musculo-skeletal (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac | Cardiac Adult | ||||||||||
| 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. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note5: TDI | |||||||||||
| Note6: Color M | |||||||||||
| Note7: Biopsy Guidance | |||||||||||
| Note8: Elastography | |||||||||||
| Note 9: Contrast imaging | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
Praisado
Illiemaeu Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
15
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: D6-2E
Intendeu Diagno
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
16
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | DE10-3E |
| 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, 3, 4, 6 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal | Neonatal Cephalic | ||||||||
| Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | P | P | P | P | P | P | Note 1, 3, 4, 6 | |
| Trans-vaginal | P | P | P | P | P | P | Note 1, 3, 4, 6 | ||
| 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. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography | |||||||||
| Note 9: Contrast imaging | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
rransado
Imendeu Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
17
DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: CW5s
Intenueu
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | Amplitude Combined | Other (specify) | |
| (Track 1 | Doppler | Doppler | (specify) | ||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal | Neonatal Cephalic | ||||||||
| 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 | Peripheral vessel | P | |||||||
| 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. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography | |||||||||
| Note 9: Contrast imaging | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
18
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: L9-3E |
| 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 | |||||||||
| Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,7 | ||
| 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, 4,7,8 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| 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 | Cardiac Adult | ||||||||
| 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***) |
19
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | DE11-3E |
| Transducer: DE11-3E | 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 | N | N | N | N | N | N | Note 1, 3, 4, 6, 7 | |||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Neonatal Cephalic | |||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1, 3, 4, 6, 7 | |||
| Trans-vaginal | N | N | N | N | N | N | Note 1, 3, 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 | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) |
| Intended | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|---|
| ---------- | ------------------------------------------------------------------------------------ |
20
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | V11-3HE |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| Doppler (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4, 6, 7 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| 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, 8 | ||
| 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 | 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 +B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography | |||||||||
| Note 9: Contrast imaging | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
21
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: C5-1E |
| 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 | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Abdominal | N | N | N | N | N | N | Note 1, 2, 4,6,7,9 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Small Organ (Specify**) | |||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | 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 etc. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography | |||||||||
| Note 9: Contrast imaging | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
22
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | CB10-4E |
| 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 | ||||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| 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 | 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 +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
23
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | P10-4E |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| General | |||||||||
| (Track 1) | Ophthalmic | ||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,4,6 | |
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,6 | |
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6 | |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6 | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6 | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography | |||||||||
| Note 9: Contrast imaging | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
24
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | SP5-1E |
| 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 | N | N | N | N | N | N | N | Note 1, 2,4, 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**) | ||||||||||
| Fetal | ||||||||||
| Imaging & | Neonatal Cephalic | |||||||||
| Other | Adult Cephalic | N | N | N | N | N | N | N | 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 | 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 | Peripheral vessel | |||||||||
| vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
25
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | D6-2NE |
| 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 | N | N | N | N | N | N | Note 1, 3, 4, 6 | ||
| Abdominal | N | N | N | N | N | N | Note 1, 3, 4, 6 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography | |||||||||
| Note 9: Contrast imaging | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
1 Parisation
Hitchuru
Hearthern Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
26
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | D7-2E |
| 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 | N | N | N | N | N | N | N | Note 1, 3, 4, 6 | ||
| Abdominal | N | N | N | N | N | N | N | Note 1, 3, 4, 6 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| Note 9: Contrast imaging | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
27
| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|---|---|
| Transducer: | P7-3TE |
| 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 | |||||||||
| Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | Note 1, 5,6 | |
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||
| **Small organ-breast, thyroid, testes. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note7: Biopsy Guidance | |||||||||
| Note8: Elastography | |||||||||
| Note 9: Contrast imaging | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) |
28
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).
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: December 15, 2016
- Device Name: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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)
29
3. Device Description:
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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, iScape,4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging 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.
4. Intended Use:
The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S 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, Trans-esoph(Cardiac), musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
5. Summary of Modifications
-
New Added Models:
DC-75, DC-78, DC-70S -
New Added Transducers:
D7-2E D6-2NE C5-1E CB10-4E P7-3TE P10-4E
30
SPS-IE V11-3HE L9-3E DE11-3E
New Added Needle-Guided Bracket: ●
NGB-022, NGB-025, NGB-027, NGB-034
● Main Added Features:
Contrast Imaging Smart FLC Tissue Tracking Elastography to V11-3E, V11-3BE, V11-3HE
6. Comparison with Predicate Devices:
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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-8 | K150080 |
| 3 | Mindray | Resona 7 | K162267 |
| 4 | Mindray | DC-60 | K152545 |
| 5 | Philips | EPIQ 5 | K160807 |
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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
31
flow, and calculations.
- . Subject device DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S has the same intended uses as the predicated device DC-70(K150204)
| Subject Device | Predicate device |
|---|---|
| DC-70/DC-70T /DC-70 PRO/DC-70 EXP | DC-70(K150204) |
| The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S 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, Trans-esoph | |
| (Cardiac), musculo-skeletal (conventional, | |
| superficial), adult and pediatric cardiac, | |
| peripheral vessel and urology exams. | 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 cephalic, adult | |
| cephalic, trans-rectal, trans-vaginal, | |
| musculo-skeletal (conventional, superficial), | |
| cardiac adult, cardiac pediatric, peripheral | |
| vessel, urology exams. |
- The acoustic power levels of DC-70/ DC-70T/ DC-70 PRO/ DC-70 EXP / DC-75/ ● DC-78/ DC-70S are below the limits of FDA, which is the same as the predicated device DC-70(K150204).
- DC-70/ DC-70T/ DC-70 PRO/ DC-70 EXP / DC-75/ DC-78/ DC-70S 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-70/ DC-70T/ DC-70 PRO/ DC-70 EXP / DC-75/ DC-78/ DC-70S has similar probes as the predicated device:
| Subject device | Predicated device |
|---|---|
| DC-70/ DC-70T/ DC-70 PRO/ | |
| DC-70 EXP / DC-75/ DC-78/ | |
| DC-70S | |
| D7-2E | D7-2E &DC-60(K152545) |
| D6-2NE | D6-2E &DC-70(K150204) |
32
| C5-1E | C5-1U& Resona 7 (K162267) |
|---|---|
| CB10-4E | CB10-4E&DC-8(K150080) |
| P7-3TE | P7-3TE&DC-8(K150080) |
| P10-4E | P10-4E&&DC-8(K150080) |
| SP5-1E | SP5-1E &DC-8(K150080) |
| V11-3HE | V11-3WE &DC-8(K150080) |
| L9-3E | L9-3U& Resona 7(K162267) |
| DE11-3E | DE11-3U & Resona 7 (K162267) |
7. Non-clinical Tests:
DC-70/ DC-70T/ DC-70 PRO/ DC-70 EXP / DC-75/ DC-78/ DC-70S 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:
- AAMI/ANSI ES60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- . AAMI/ANSI/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
- IEC 62304: Medical device software - Software life cycle processes
- IEC:62366:Medical devices application of usability engineering to medical devices ●
- IEC 60601-1-6: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
- ISO14971: Medical devices - Application of risk management to medical devices
- UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
- . UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
33
- . ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.
8. Clinical Studies
Not applicable. The subject of this submission, DC-70/ DC-70T/ DC-70 PRO/ DC-70 EXP / DC-75/ DC-78/ DC-70S 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-70/ DC-70T/ DC-70 PRO/ DC-70 EXP / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.